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Xyrem sodium oxybate Medically reviewed by Tanya Kertsman, PharmD — By Jennifer Mitri Williamson, Pharm.D. — Updated on August 5, 2022
What is Xyrem Xyrem is a brand-name prescription drug that’s FDA-approved to treat narcolepsy.
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This condition is a sleep disorder that affects how well you’re able to sleep. And it can cause you to feel extremely tired when you’re not at rest. Narcolepsy may cause hallucinations or cataplexy (sudden muscle weakness or paralysis).
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It can also cause sleep paralysis (the inability to move while you’re sleeping). Xyrem treats narcolepsy by reducing both cataplexy and excessive daytime sleepiness (EDS). It’s approved for this use in adults and children ages 7 years and older.
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Xyrem contains the drug sodium oxybate, which belongs to a class of medications called central nervous system (CNS) depressants. Xyrem is thought to work by increasing the amount of time that your body spends in a deep sleep when you’re resting.
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This helps to decrease sleepiness when you’re not at rest. Xyrem comes as a solution that’s taken by mouth.
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It’s usually taken at bedtime and then again, 2.5 to 4 hours later. Xyrem is available in one strength: 0.5 grams per milliliter (g/mL).
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Effectiveness
In clinical trials, Xyrem was effective in treating narcolepsy by reducing both EDS and cataplexy. During treatment, adults who took either 6 g or 9 g of Xyrem each night had between 10 and 16 fewer cataplexy episodes each week. In comparison, people taking a placebo (no active drug) had 4 fewer cataplexy episodes each week.
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Xyrem also reduced EDS in adults using the drug. In one clinical study, a scale called the Clinical Global Impression of Change was used to measure the change in EDS that people had after taking Xyrem for 8 weeks.
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In this study, between 52% and 64% of people taking Xyrem had a significant reduction in their EDS. In comparison, about 22% of people taking a placebo had the same result. For information about Xyrem’s effectiveness in children, see the “Xyrem uses” section below.
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FDA approval
In 2002, Xyrem was approved by the Food and Drug Administration (FDA) for use in adults with narcolepsy. And in 2018, Xyrem was FDA-approved to treat narcolepsy in children ages 7 and older. Is Xyrem a controlled substance
Yes, Xyrem is a controlled substance.
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This means the use of Xyrem is regulated by the federal government. Xyrem is a controlled drug because it has the potential to be misused. For example, some people taking the medication may become dependent on it.
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(With dependence, your body needs the drug in order to feel like usual.) It’s also possible to build up a tolerance to Xyrem. (With tolerance, you need to take more medication to have the same effect over time.) Some people may also have cravings for Xyrem. Xyrem contains the drug sodium oxybate.
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It’s a form of another drug called gamma-hydroxybutyrate (GHB). GHB is a Schedule I (one) controlled substance that’s commonly misused and is illegal. In fact, Schedule I controlled substances have no accepted medical use.
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And they have a high potential for misuse. Schedule I drugs also lack information on the safety of their use. However, Xyrem, which is a form of GHB, is a Schedule III (three) drug.
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This means that it does have an approved medical use. And it was shown to be safe and effective in treating narcolepsy during clinical trials. Due to the risks associated with Xyrem treatment, the FDA requires that Xyrem only be prescribed through a Risk Evaluation and Mitigation Strategy (REMS) program.
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See “REMS program” just below for details. If you have questions about the risk of misusing Xyrem, talk with your doctor.
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They can help you choose a treatment plan that’s best for you. REMS program
The Xywav and Xyrem REMS program is used to help decrease the risk of serious side effects of Xyrem, such as misuse and central nervous system (CNS) depression. This program limits how freely Xyrem is prescribed (as well as a similar drug called Xywav).
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With the REMS program, Xyrem can only be prescribed by doctors who are certified to offer Xyrem treatment. Xyrem can also only be dispensed by pharmacies that are registered with the REMS program.
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And Xyrem can only be dispensed to people who are enrolled in the REMS program with documentation of safe use of the drug. For people who may have misused drugs in the past, their doctor may monitor them closely during Xyrem treatment.
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This allows their doctor to be sure that Xyrem isn’t being misused. You can learn more about this at the program website.
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If you have questions about the risk of misusing Xyrem, talk with your doctor. They can help you choose a treatment plan that’s best for you. Xyrem side effects
Xyrem can cause mild or serious side effects.
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The following lists contain some of the key side effects that may occur while taking Xyrem. These lists do not include all possible side effects. For more information on the possible side effects of Xyrem, talk with your doctor or pharmacist.
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They can give you tips on how to deal with any side effects that may be bothersome. Note: The Food and Drug Administration (FDA) tracks side effects of drugs they have approved. If you would like to report to the FDA a side effect you’ve had with Xyrem, you can do so through MedWatch.
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Mild side effects
The mild side effects of Xyrem that are more common* can include:nauseadizzinessvomitingtremorfeeling sleepy or drowsybedwetting
The mild or moderate side effects of Xyrem that are less common† can include:diarrheaupper abdominal paindry mouthfeeling intoxicatedswelling in your arms or legspain in your arms or legs, or all over your bodymuscle spasmscataplexy (sudden muscle weakness or paralysis)feeling pins and needles in your hands, feet, arms, or legshaving trouble paying attentionsleep paralysis (being unable to move while you’re sleeping)feeling disorientedbeing irritablesweating more than usual * “More common” means the side effect occurred in 5% or more of people who took Xyrem in clinical trials. It also means it occurred at least two times more often in people who took Xyrem compared to those who took a placebo. A placebo is a treatment without an active drug.
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† “Less common” means that side effect occurred in less than 5% of people who took Xyrem in clinical trials. It also means it occurred in people who took Xyrem less than twice as often as it occurred in people who took a placebo. Many of these side effects may go away within a few days or a couple of weeks.
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But if they become more severe or don’t go away, talk with your doctor or pharmacist. Serious side effects
Serious side effects from Xyrem can occur. Call your doctor right away if you have serious side effects.
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Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include:Mental changes. Symptoms can include:hallucinations (seeing or hearing things that aren’t really there)having abnormal thoughtsfeeling upsetthoughts of suicidefeelings of guilt or worthlessnessincreased tirednessanxietydepressionconfusiondifficulty concentratingSleepwalking.
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Symptoms, which occur during sleep, can include:repeated movements, such as rubbing your eyesnot responding to other peoplewalking or moving around as if you’re awakeunable to be woken uptalkingCentral nervous system (CNS) depression, including breathing problems.*Severe allergic reaction.†Misuse (sometimes called abuse) of the drug.* * Xyrem has boxed warnings from the FDA about this risk. Boxed warnings are the strongest warning the FDA requires. They alert doctors and patients about drug effects that may be dangerous.
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See “Side effect details” below for more information. † See “Side effect details” below for more information about this. Suicide prevention
If you know someone at immediate risk of self-harm, suicide, or hurting another person:Ask the tough question: “Are you considering suicide?”Listen to the person without judgment.Call 911 or the local emergency number, or text TALK to 741741 to communicate with a trained crisis counselor.Stay with the person until professional help arrives.Try to remove any weapons, medications, or other potentially harmful objects.
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If you or someone you know is having thoughts of suicide, a prevention hotline can help. The 988 Suicide and Crisis Lifeline is available 24 hours a day at 988.
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During a crisis, people who are hard of hearing can use their preferred relay service or dial 711 then 988. Click here for more links and local resources.
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Side effects in children
Xyrem is approved for use in children ages 7 years and older. During clinical trials, the most common side effects seen in children included:bedwettingnauseaheadachevomitingweight lossdecreased appetitedizzinesssleepwalking
More serious side effects can also occur in children. These include:slowed or troubled breathinganxietyangeruncontrollable laughing or cryingsleep apneadepression or thoughts of suicidepsychiatric side effects, such as hallucinationsabnormal movements, thoughts, or behaviors while sleeping
Some children using Xyrem during studies actually stopped taking the drug because of these side effects.
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If you or your child has side effects of Xyrem that are serious or bothersome, talk with your doctor. They can recommend ways to help reduce the side effects. Call 911 (or your local emergency number) if the symptoms feel life threatening or if you think you or your child may be having a medical emergency.
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Side effect details
You may wonder how often certain side effects occur with this drug, or whether certain side effects pertain to it. Here’s some detail on several of the side effects this drug may cause. Allergic reaction
As with most drugs, some people can have an allergic reaction after taking Xyrem.
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It wasn’t reported how many people had an allergic reaction to Xyrem during clinical trials. Symptoms of a mild allergic reaction can include:skin rashitchinessflushing
A more severe allergic reaction is rare but possible.
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Symptoms of a severe allergic reaction can include:swelling under your skin, typically in your eyelids, lips, hands, or feetswelling of your tongue, mouth, or throattrouble breathing
Call your doctor right away if you have a severe allergic reaction to Xyrem. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency. Weight loss or weight gain
Weight loss is a possible side effect of Xyrem.
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However, weight gain wasn’t a side effect of the drug during clinical trials. It wasn’t reported how many adults had weight loss during clinical trials.
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But for children, weight loss was a common side effect of Xyrem. In fact, weight loss occurred in 13% of children taking the drug. It’s not known how many people taking a placebo (no active drug) had weight loss.
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If you notice changes in your weight during Xyrem treatment, talk with your doctor. They can help you manage a body weight that’s healthy for you. Anxiety
It’s possible to have anxiety while you’re taking Xyrem.
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Symptoms of anxiety may include feeling nervous, panicking, or having an increased heart rate. Anxiety did occur in some people during Xyrem’s clinical trials, but it was a rare side effect. For example, in adults taking the drug, anxiety occurred in 1% of those taking 4.5 grams (g) or 6 g of Xyrem each night.
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And it occurred in 2% of people taking 9 g of Xyrem each night. In comparison, anxiety occurred in 1% of people taking a placebo (no active drug).
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If you start to feel anxious while you’re taking Xyrem, talk with your doctor. They’ll recommend ways to help decrease your anxiety. Sleep apnea
Sleep apnea is a possible side effect of Xyrem.
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With sleep apnea, you have periods of time when your breathing stops and restarts while you’re asleep. It’s not known how many people in clinical trials had sleep apnea that was caused by Xyrem.
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Symptoms of sleep apnea can include:feeling tired after periods of restsnoringhaving a headache after waking upgasping or choking while you’re sleeping
If you have symptoms of sleep apnea while you’re taking Xyrem, talk with your doctor. They may order certain tests to check and see if you have the condition.
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Xyrem and obstructive sleep apnea
Clinical trials showed that for people with obstructive sleep apnea who took 9 g of Xyrem each night, there was no increase in how severe their sleep apnea was. (With obstructive sleep apnea, soft tissue, such as that in your mouth or throat, relaxes and blocks your airway.)
During Xyrem treatment, the people also didn’t have larger decreases in their oxygen level than usual.
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And they didn’t have any longer periods of time with reduced oxygen levels than they had experienced before Xyrem treatment. Xyrem and central sleep apnea
During clinical trials, people with obstructive sleep apnea did have an increased risk of central sleep apnea.
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(With central sleep apnea, your brain doesn’t send messages to your muscles to help you breathe.)
Of the people affected by central sleep apnea, 6% had a large decrease in the amount of oxygen in their blood. Central sleep apnea can be serious, because a lower oxygen level in your blood means that your vital organs are getting less oxygen.
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Central nervous system depression
Xyrem can cause central nervous system (CNS) depression in some people. In fact, Xyrem belongs to a class of medications called CNS depressants.
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And Xyrem has a boxed warning from the FDA regarding the risk of CNS depression. A boxed warning is the strongest warning the FDA requires.
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It alerts doctors and patients about drug effects that may be dangerous. Xyrem and other CNS depressant drugs work by relaxing your central nervous system, including muscles that help you breathe.
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With CNS depression, the function of your central nervous system is slowed down too much. Sometimes this can cause respiratory depression (slow, weak breathing), which can be life threatening.
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Other symptoms of CNS depression can include:feeling sleepyblurry visionslurred speechinability to think clearlyslow reflexestrouble breathinglow blood pressuredrowsinessfainting
You should not do things that require you to be fully awake or are dangerous for at least 6 hours after taking Xyrem. This includes driving a car and operating machinery. This is important because the drug can decrease your ability to move or react.
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It may also slow down your ability to think and impair your judgement. When you first start taking Xyrem, you should avoid activities that require you to be fully awake until you know how Xyrem can affect you. If you have any symptoms of CNS depression while you’re taking Xyrem, call your doctor right away.
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If you feel that your symptoms are life threatening, call 911. Risk factors for CNS depression
Taking a CNS depressant, such as Xyrem, along with alcohol or medications that cause sedation increases your risk of CNS depression.
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Because of this risk, if you drink alcohol, you should never drink it while you’re taking Xyrem. During Xyrem treatment, you should also avoid using medications that cause sedation. Taking other drugs that are CNS depressants along with Xyrem can increase your risk of respiratory depression.
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With respiratory depression, you have weak and slow breathing. In some cases, this condition can be fatal. Examples of other CNS depressants that should be avoided while you’re taking Xyrem include:opioids (strong pain relievers), such as oxycodonebenzodiazepines, such as clonazepamgeneral anestheticsmedications that make you sleepy, which may include certain sedatives, antidepressants, antipsychotics, or seizure medicationsmuscle relaxants, such as cyclobenzaprineillegal CNS depressants, such as heroin or gamma-hydroxybutyrate (GHB)alcohol
Be sure to tell your doctor about all the medications you’re taking.
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If you need to take another CNS depressant with Xyrem, your doctor may change your dosages of the drugs so that they aren’t dangerous when taken together. If you need to take a CNS depressant for just a short period of time, your doctor may even have you stop taking Xyrem while you’re taking the other drug. This helps you to avoid having an increased risk of CNS depression.
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Note: Xyrem can only be prescribed through a Risk Evaluation Mitigation Strategy (REMS) program due to its risk of CNS depression and misuse. This means only certain doctors and pharmacies are able to prescribe and dispense this medication. See “REMS program” under “What is Xyrem ” above for details.
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Misuse
Xyrem has the potential to be misused. In fact, Xyrem has a boxed warning from the FDA regarding the risk of drug misuse (sometimes called abuse).
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Some people taking Xyrem may become dependent on it. (With dependence, your body needs the drug in order to feel like usual.) It’s also possible to build up a tolerance to Xyrem.
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(With tolerance, you need to take more medication to have the same effect over time.) Some people also have cravings for the medication. These conditions can all lead to misuse of Xyrem. Xyrem contains the active drug sodium oxybate.
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It’s a form of another drug called gamma-hydroxybutyrate (GHB). GHB is a substance that’s commonly misused and is illegal. Misuse of either GHB or Xyrem can cause serious CNS side effects, such as seizures, decreased consciousness, respiratory depression, coma, or even death.
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It’s not known how many people taking Xyrem during clinical trials misused the medication. But due to its high potential for misuse and the risk of CNS depression, Xyrem is only prescribed through a Risk Evaluation Mitigation Strategy (REMS) program. This means only certain doctors and pharmacies are able to prescribe and dispense the drug.
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See “REMS program” under “What is Xyrem ” above for details. Xyrem generic
Xyrem is available only as a brand-name medication.
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It’s not currently available in generic form. A generic drug is an exact copy of the active drug in a brand-name medication. Xyrem contains the active drug sodium oxybate.
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Xyrem uses
The Food and Drug Administration (FDA) approves prescription drugs such as Xyrem to treat certain conditions. Xyrem may also be prescribed off-label for other conditions.
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Off-label use is when a drug that’s approved to treat one condition is prescribed to treat a different condition. Xyrem for narcolepsy
Xyrem is FDA-approved to treat narcolepsy. This condition is a sleep disorder that affects how well you’re able to sleep.
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With narcolepsy, you may have difficulty staying awake, but also have trouble staying in a deep sleep when you’re resting. Symptoms of narcolepsy may include:excessive daytime sleepiness (EDS)hallucinations (seeing or hearing things that aren’t really there)waking up while you’re trying sleepsleep paralysis (being unable to move while you’re sleeping)
There are two types of narcolepsy: narcolepsy with cataplexy and narcolepsy without cataplexy. With cataplexy, you have sudden muscle weakness or paralysis.
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Typically, people with cataplexy have more severe forms of narcolepsy. You can learn more about narcolepsy and sleep from our sleep hub. Xyrem treats narcolepsy by reducing both cataplexy and excessive daytime sleepiness (EDS).
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It’s approved for use in adults and children ages 7 years and older. Effectiveness for narcolepsy
In clinical trials, Xyrem was effective in treating narcolepsy by reducing both EDS and cataplexy. During treatment, adults who took either 6 g or 9 g of Xyrem each night had between 10 and 16 fewer cataplexy episodes each week.
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In comparison, people taking a placebo (no active drug) had 4 fewer cataplexy episodes each week. Xyrem also reduced EDS in adults using the drug. In one clinical trial, a scale called the Clinical Global Impression of Change was used to measure the change in EDS that people had after taking Xyrem for 8 weeks.
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In this study, between 52% and 64% of people taking Xyrem had a significant reduction in their EDS. In comparison, about 22% of people taking a placebo had the same result. Xyrem and children
Xyrem is approved to treat narcolepsy in children ages 7 years and older.
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In clinical trials, Xyrem was effective in treating narcolepsy in children by reducing both EDS and cataplexy. In the studies, treatment with Xyrem decreased the children’s number of cataplexy attacks compared to treatment with a placebo (no active drug).
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During treatment, children taking Xyrem had about 3.8 cataplexy attacks each week. In comparison, children taking the placebo had 21.3 cataplexy attacks each week.
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Children also had reduced EDS while they were taking Xyrem. The Epworth Sleepiness Scale for children and adolescents was used to measure the severity of their EDS. (A higher EDS score means that a person is more tired than someone with a lower EDS score.) The study showed that children taking Xyrem had an EDS score of 9.
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For children taking the placebo, the EDS score was 12. Off-label uses for Xyrem
In addition to the use listed above, Xyrem may be prescribed off-label.
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Off-label drug use is when a drug that’s approved for one use is prescribed for a different one that’s not approved. Xyrem for fibromyalgia
Xyrem isn’t currently approved to treat fibromyalgia.
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In fact, in 2010, the FDA decided not to approve Xyrem for this use. But sometimes, Xyrem is prescribed off-label to treat the condition. Fibromyalgia causes pain or stiffness in your muscles and joints.
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It can also make you feel very tired. It’s not known exactly what causes fibromyalgia, but it’s thought be due to certain other health conditions.
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If you’d like to know more about treatment options for fibromyalgia, talk with your doctor. Effectiveness for fibromyalgia
Some studies have shown that Xyrem may be effective in treating fibromyalgia.
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In one study, between 42% and 51.4% of people taking Xyrem reported a reduction of 30% or more in their pain with treatment. In comparison, 26.8% of people taking a placebo (no active drug) had the same outcome. People taking Xyrem also had up to 20% to 25% improvement in their quality of sleep.
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In comparison, people taking the placebo had a 0.5% improvement in their sleep. However, up to about 20% of people in the study stopped using Xyrem because they had side effects from the drug.
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In comparison, only about 5% of people using the placebo stopped treatment because of side effects. Xyrem for idiopathic hypersomnia
Xyrem isn’t FDA-approved to treat idiopathic hypersomnia.
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But sometimes, it’s prescribed off-label for this purpose. Idiopathic hypersomnia is a rare condition that’s very similar to narcolepsy. With either condition, you may have EDS.
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However, people with idiopathic hypersomnia may sleep for a long time and find it very difficult to wake up after resting. In comparison, people with narcolepsy usually can’t sleep for very long, and they may feel very rested after just a short nap.
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Also, cataplexy (sudden muscle weakness or paralysis) typically occurs only with narcolepsy. It’s not a possible symptom of idiopathic hypersomnia. If you’d like to know more about treatment options for idiopathic hypersomnia, talk with your doctor.
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Effectiveness for idiopathic hypersomnia
One study reviewed medical charts of people taking Xyrem for idiopathic hypersomnia. The review showed that Xyrem had decreased people’s severe morning fogginess (also called morning inertia).
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In fact, 71% of people taking the medication had this result. There weren’t any people in the study taking a placebo (no active drug).
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However, this review also showed that side effects of Xyrem were common in people using the drug. As a result, about 53% of people stopped taking the medication within 15.8 months.
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There’s also a study that’s currently being done to test the safety and effectiveness of Xyrem in people with idiopathic hypersomnia. This study hasn’t been completed yet.
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Xyrem for alcohol use disorder or alcohol withdrawal
Xyrem isn’t FDA-approved to treat either alcohol use disorder or alcohol withdrawal. However, in countries other than the United States, Xyrem is approved to treat alcohol use disorder.
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Specifically, Xyrem is approved for this use in Italy and Austria. With alcohol use disorder, someone may have trouble controlling how much alcohol they drink.
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Or they may continue to drink alcohol even if it’s having a bad effect on their life. Alcohol withdrawal happens when you try to stop using alcohol after your body has become dependent on it from long-term use.
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(With dependence, your body needs the substance in order to feel like usual.)
If you drink alcohol, it’s important to note that you should never drink it while you’re taking Xyrem. See the section below called “Xyrem and alcohol” for more information.
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If you’d like to know more about treatment options for either alcohol use disorder or alcohol withdrawal, talk with your doctor. Effectiveness for alcohol use disorder or alcohol withdrawal
One study looking at alcohol use disorder treatment compared the use of gamma-hydroxybutyrate (GHB) with that of medications that are approved to treat the condition. (Xyrem is a form of GHB.) These approved medications included naltrexone (Revia) and disulfiram (Antabuse).
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This study was published in the American Psychiatric Association’s guidelines for alcohol use disorder treatment. It showed that each treatment had about the same result in decreasing the amount of alcohol that people consumed.
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However, a greater decrease in alcohol cravings seemed to occur in people taking GHB rather than either naltrexone or disulfiram. Some studies have also looked at using Xyrem in people with alcohol withdrawal. In one study, Xyrem was just as effective as oxazepam (Serax) in treating alcohol withdrawal.
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(Oxazepam is currently the most commonly used drug that’s approved for treating alcohol withdrawal.)
Xyrem use with other drugs
Xyrem is approved to treat narcolepsy (a sleep disorder that can make you feel extremely tired). It works by reducing cataplexy (sudden muscle weakness or paralysis) and excessive daytime sleepiness (EDS). Xyrem belongs to a class of drugs called central nervous system (CNS) depressants.
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It’s taken at bedtime and then again 2.5 hours to 4 hours later. It works by helping you to sleep better when you’re resting so that you’re not as sleepy as usual when you wake up. Medications called stimulants may sometimes be used along with Xyrem to help treat EDS.
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Stimulant medications work by helping you to stay awake when you’re not at rest. They also help you feel less sleepy and have a better ability to focus. Examples of stimulant medications that are approved for use in people with narcolepsy include:modafinil (Provigil)armodafinil (Nuvigil)methylphenidate (Ritalin, Concerta)amphetamine salts (Adderall)
If you’re still having EDS after starting Xyrem, talk with your doctor.
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They may recommend another medication for you, such as a stimulant, to help you stay awake and be more focused. Common questions about Xyrem
Here are answers to some frequently asked questions about Xyrem. Can Xyrem be used to treat insomnia
No, Xyrem isn’t approved to treat insomnia (trouble sleeping).
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Xyrem is only approved to treat narcolepsy (a sleep disorder that can make you feel extremely sleepy). The drug works by reducing cataplexy (sudden muscle weakness or paralysis) and excessive daytime sleepiness (EDS). At this point, there’s no information available on the safety or effectiveness of Xyrem in people with insomnia.
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One study was started in 2006 to look at Xyrem treatment in people with insomnia that was caused by post-traumatic stress disorder (PTSD). But the study wasn’t completed because there weren’t enough people who wanted to be included in it. If you have questions about treatment options for insomnia, talk with your doctor.
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Can Xyrem be misused or cause addiction
Yes, Xyrem can be misused. In fact, Xyrem has a boxed warning from the FDA regarding the risk of misuse (sometimes called abuse). A boxed warning is the strongest warning the FDA requires.
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It alerts doctors and patients about drug effects that may be dangerous. Xyrem is a form of gamma-hydroxybutyrate (GHB), which is an illegal drug that’s commonly misused. Xyrem may cause dependence in some people using the medication.
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(With dependence, people need to take the medication in order to feel like usual.) It’s also possible to build up a tolerance to Xyrem. (With tolerance, you need more and more of the medication in order for it to have the same effect in your body.) Either of these conditions may lead to misuse of the drug. Due to the risks associated with Xyrem treatment, Xyrem is prescribed through a Risk Evaluation and Mitigation Strategy (REMS) program.
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See “REMS program” in the “What is Xyrem ” section above for details. To help avoid these conditions, it’s important that you take Xyrem exactly as your doctor recommends.
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For more information about the risk of misuse with Xyrem, see the “Xyrem side effects” section above. If you have concerns about developing dependence or tolerance while you’re taking Xyrem, talk with your doctor.
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Will Xyrem show up on a drug test
Yes, Xyrem does show up on certain drug screens. This medication is a form of gamma-hydroxybutyrate (GHB), which is an illegal drug.
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Xyrem may turn positive certain drug tests that are screening for GHB. Certain drug tests, such as those used by employers, may not screen for GHB. Most drug tests look for drugs that are commonly misused, such as:amphetamines, including:amphetamine salts (Adderall and Adderall XR)methamphetaminebenzodiazepines, including lorazepam (Ativan)barbiturates, including phenobarbitalopioids, including:oxycodone (Roxicodone)methadone (Dolophine)marijuanacocainephencyclidine (PCP)
However, if you’re taking Xyrem as your doctor recommends, you should have a prescription for the drug.
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You’ll want to bring your prescription or a doctor’s note with you whenever you’re having a drug test done. Having one of these items with you should serve as proof that you’re taking Xyrem under the recommendation of your doctor.
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Is there a way for me to talk with other people who ve used Xyrem
There might be. A program called JazzCares is available for Xyrem, which lets you speak with a healthcare professional who is familiar with Xyrem treatment.
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Through this program, you may be able to speak with people who have narcolepsy and experience cataplexy (sudden muscle weakness or paralysis) and excessive daytime sleepiness (EDS). Or you may speak with a caregiver of someone with these conditions.
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To register for the JazzCares program, visit the program website or call 866-997-3688. Can I take Xyrem if I have sleep apnea
Yes, you should be able to take Xyrem if you have sleep apnea.
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With sleep apnea, you have periods of time when your breathing stops and restarts while you’re asleep. In clinical trials, some people had obstructive sleep apnea before starting Xyrem treatment.
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(With obstructive sleep apnea, soft tissue, such as that in your mouth or throat, relaxes and blocks your airway as you sleep.) Most of these people were able to safely take Xyrem. But some of the people stopped participated in the studies because their sleep apnea worsened or they had low oxygen levels in their bodies.
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It’s not known for sure if Xyrem caused these problems. Sleep apnea is a possible side effect of Xyrem.
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For more information on sleep apnea as a side effect, see the section “Xyrem side effects” above. If you have sleep apnea, talk with your doctor before starting Xyrem. They may order a sleep study to monitor your sleep apnea after you start taking Xyrem.
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This allows your doctor to see if your condition worsens during treatment. Xyrem dosage
The Xyrem dosage your doctor prescribes will depend on several factors. These include:the type and severity of your conditionyour ageother medical conditions you may haveother medications you are taking
Typically, your doctor will start you on a low dosage.
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Then they’ll adjust it over time to reach the amount that’s right for you. Your doctor will ultimately prescribe the smallest dosage that provides the desired effect.
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The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you.
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Your doctor will determine the best dosage to fit your needs. Drug forms and strengths
Xyrem comes as a solution that’s taken by mouth. It’s available in one strength: 0.5 grams per milliliter (g/mL).
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Note: Xyrem should be diluted with water before it’s taken. Dosage for narcolepsy
The typical dosage of Xyrem for narcolepsy is based on dosing schedule. With this dosing schedule, the dose of Xyrem that you take daily will increase over time until you reach your recommended dose.
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When you first start Xyrem treatment, you’ll take 4.5 g of the drug daily. This amount of Xyrem is always divided into two doses. The first dose is typically taken at your planned bedtime.
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The second dose is taken 2.5 hours to 4 hours after the first dose. So, when first starting Xyrem, you’ll take 2.25 g at bedtime and then 2.25 g a few hours later.
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During each week of treatment, your doctor may increase your dosage of Xyrem until you get to the typical recommended dose of 6 g to 9 g daily. Your doctor will likely increase your dose by 1.5 g per night each week.
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This means that after one week of treatment, you’ll start taking 6 g of the drug each day. (This would be divided as 3 g of the drug at bedtime and an additional 3 g a few hours later.)
You may need to set an alarm clock to be sure that you’re awake to take your second dose of Xyrem.
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Because Xyrem makes you fall asleep very quickly, it should only be taken at bedtime. You should take every dose while in bed.
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Lie down immediately after taking it, and remain in bed after taking each dose. And keep in mind that your doses of Xyrem need to be diluted before they’re taken.
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See the section “How to take Xyrem” below for more information about how to correctly take Xyrem. Pediatric dosage
When it’s used in children, Xyrem should also be taken twice daily. Recommended doses of Xyrem for children, which are described below, are based on the child’s body weight.
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As with adults, the daily recommended dose for children is always divided into two doses: one that’s taken at bedtime and one that’s taken 2.5 hours to 4 hours later. For children who weigh:Less than 20 kilograms (about 44 pounds): There isn’t a current recommended dosage of Xyrem. This is because the drug hasn’t been studied in children with this body weight.
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If Xyrem is used in children weighing less than 20 kilograms, it should be started at a low dose and increased in smaller amounts than usual. Children in this weight range should also have a lower maximum daily dose than children with a higher body weight.20 kilograms to less than 30 kilograms (about 66 pounds): The starting dosage is less than or equal to 1 g of Xyrem taken twice daily. The total daily dose can be increased once a week by a maximum of 1 g (0.5 g per single dose).
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The maximum dose of Xyrem for children in this weight range is 3 g twice daily.30 kilograms to less than 45 kilograms (about 99 pounds): The starting dosage is less than or equal to 1.5 g of Xyrem taken twice daily. The total daily dose can be increased once a week by a maximum of 1 g (0.5 g per single dose).
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The maximum dose of Xyrem for children in this weight range is 3.75 g twice daily.45 kilograms or more: The starting dosage of Xyrem is less than or equal to 2.25 g taken twice daily. The total daily dose can be increased once a week by a maximum of 1.5 g (0.75 g per single dose).
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The maximum dosage of Xyrem for children in this weight range is 4.5 g twice daily. What if I miss a dose
During Xyrem treatment, you should take your first daily dose of the drug at bedtime. If you miss a dose of Xyrem, take it as soon as you remember, unless you’re not planning to rest at that time.
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After taking your first dose, you’ll take your second dose as usual, 2.5 hours to 4 hours later. If you already took your first dose, but you missed your second dose, just skip the second dose. And don’t take any additional Xyrem until the next day or night, when you would usually take it at bedtime.
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Never take more than one dose of Xyrem at once. Doing so can increase your risk of serious side effects of the drug. To help make sure that you don’t miss a dose, try setting a reminder on your phone.
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A medication timer may be useful, too. Will I need to use this drug long term
Xyrem is meant to be used as a long-term treatment. If you and your doctor determine that Xyrem is safe and effective for you, you’ll likely take it long term.
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Alternatives to Xyrem
Other drugs are available that can treat narcolepsy. Some may be a better fit for you than others. If you’re interested in finding an alternative to Xyrem, talk with your doctor.
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They can tell you about other medications that may work well for you. Note: Some of the drugs listed below are prescribed off-label to treat these specific conditions.
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Off-label use is when a drug that’s approved to treat one condition is prescribed to treat a different condition. Examples of drugs other than Xyrem that may be used to treat narcolepsy include:modafinil (Provigil)armodafinil (Nuvigil)methylphenidate (Ritalin, Concerta)fluoxetine (Prozac)imipramine (Tofranil)clomipramine (Anafranil)dextroamphetamine (Adderall)atomoxetine (Strattera)venlafaxine ER (Effexor XR)
Xyrem vs Xywav
Xyrem and Xywav are similar drugs, but they have some differences. Xyrem contains the active drug sodium oxybate.
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Xywav contains sodium oxybate, calcium oxybate, magnesium oxybate, and potassium oxybate. Each drug comes as a solution that’s taken by mouth. Both drugs are used to reduce cataplexy (sudden muscle weakness or paralysis) and excessive daytime sleepiness (EDS) caused by narcolepsy.
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Xyrem and Xywav can be given to adults and children ages 7 years and older with narcolepsy. Xywav also treats idiopathic hypersomnia in adults. Idiopathic hypersomnia is a rare condition that’s very similar to narcolepsy.
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Xyrem is not approved to treat this condition, but is sometimes prescribed off-label for this use. (With off-label use, a drug that’s approved to treat certain conditions is prescribed to treat another.) See “Xyrem for idiopathic hypersomnia” under “Xyrem uses” above for details. Xyrem and Xywav can only be prescribed through a Risk Evaluation Mitigation Strategy (REMS) program that’s specific to these two drugs.
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This means only certain doctors and pharmacies are able to prescribe and dispense Xyrem and Xywav. This is because of the drugs’ risks of misuse and central nervous system (CNS) depression. See “Xyrem side effects” above for details about these side effects.
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You can talk with your doctor or pharmacist for more information about how these drugs compare. Xyrem vs Provigil
You may wonder how Xyrem compares with other medications that are prescribed for similar uses.
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Here we look at how Xyrem and Provigil are alike and different. Ingredients
Xyrem contains the drug sodium oxybate, while Provigil contains the drug modafinil.
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Uses
Xyrem is approved to treat narcolepsy (a sleep disorder that can make you feel extremely tired). It works by reducing both cataplexy (sudden muscle weakness or paralysis) and excessive daytime sleepiness (EDS). Xyrem can be given to adults and children ages 7 years and older.
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Provigil is approved to treat narcolepsy by increasing wakefulness in adults with EDS. Provigil is also approved to decrease EDS in adults with the following conditions:obstructive sleep apnea (a condition where soft tissue, such as that in your mouth or throat, relaxes and blocks your airway as you sleep)shift work sleep disorder (a sleep disorder that affects people who work nontraditional hours)
Xyrem and Provigil are sometimes taken together to help improve symptoms of narcolepsy.
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Xyrem is a central nervous system (CNS) depressant. It improves your sleep by reducing cataplexy, which also decreases EDS.
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Provigil, on the other hand, is a stimulant drug. It helps to decrease sleepiness when you’re not at rest.
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Drug forms and administration
Xyrem comes as a liquid solution. It’s taken by mouth at bedtime and then again 2.5 hours to 4 hours later.
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Xyrem makes you sleepy very quickly, so it should be taken only at bedtime. Provigil comes as tablets that are taken by mouth, typically once each day.
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It’s a stimulant medication, so it should be taken when you’re awake and not planning to rest. Side effects and risks
Xyrem and Provigil both contain medications that are used to treat EDS caused by narcolepsy. Therefore, these medications can cause very similar side effects.
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Below are examples of these side effects. Mild side effects
These lists contain examples of mild side effects that can occur with Xyrem, with Provigil, or with both drugs (when taken individually).Can occur with Xyrem:vomitingtremorfeeling sleepy or drowsybedwettingCan occur with Provigil:headachestuffy nosenervousnessback paininsomnia (trouble sleeping)upset stomachCan occur with both Xyrem and Provigil:nauseadiarrheadizziness
Serious side effects
These lists contain examples of serious side effects that can occur with Xyrem, with Provigil, or with both drugs (when taken individually).Can occur with Xyrem:central nervous system (CNS) depression (reduced function of your brain),* which may cause slowed breathingsleepwalkingCan occur with Provigil:serious rash, such as Stevens-Johnson Syndromeallergic reaction that involves several organs in your bodypsychiatric symptoms, such as psychosis or maniaheart problems, such as chest pain or abnormal heart rhythmCan occur with both Xyrem and Provigil:severe allergic reactionmental changes, such as depression, hallucinations (seeing or hearing things that aren’t really there), anxiety, or thoughts of suicidemisuse (sometimes called abuse)* * Xyrem has boxed warnings from the FDA regarding the risks of CNS depression and drug misuse.
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A boxed warning is the strongest warning the FDA requires. It alerts doctors and patients about drug effects that may be dangerous. See “Xyrem side effects” above for details.
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Effectiveness
Xyrem and Provigil have different FDA-approved uses, but they’re both used to treat EDS that’s related to narcolepsy. These medications have been taken together to help reduce symptoms of narcolepsy.
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In fact, during clinical trials of Xyrem, people taking Provigil were allowed to continue taking it while they also took Xyrem. These drugs haven’t been directly compared in clinical trials.
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But separate studies have found both Xyrem and Provigil to be effective in treating EDS related to narcolepsy. In a study that looked at the effectiveness of these drugs across multiple clinical trials, Provigil and Xyrem had about the same effectiveness in decreasing EDS. Costs
Xyrem and Provigil are both available as brand-name drugs.
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There is a generic form of Provigil available called modafinil. A generic drug is an exact copy of the active drug in a brand-name medication. The generic is considered to be just as safe and effective as the original drug.
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Brand-name medications usually cost more than generics. Xyrem is more expensive than either brand-name Provigil or its generic form, modafinil. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.
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Xyrem vs Effexor XR
You may wonder how Xyrem compares with other medications that are prescribed for similar uses. Here we look at how Xyrem and Effexor XR are alike and different.
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Ingredients
Xyrem contains the active drug sodium oxybate, while Effexor XR contains venlafaxine. Effexor XR in an extended-release drug, which means that the medication releases slowly over time into your body.
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Uses
Xyrem is approved to treat narcolepsy (a sleep disorder that can make you feel extremely tired). It works by reducing both cataplexy (sudden muscle weakness or paralysis) and excessive daytime sleepiness (EDS).
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Xyrem can be given to adults and children ages 7 years and older. Effexor XR isn’t approved to treat narcolepsy.
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But sometimes it’s prescribed off-label for this purpose. (With off-label use, a drug that’s approved to treat certain conditions is prescribed to treat another.)
In some articles and guidelines, Effexor XR is mentioned as a second treatment option for people with cataplexy. And according to an article that discussed new treatment options for narcolepsy, Effexor XR is the preferred medication to use with Xyrem for reducing cataplexy.
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Effexor XR is also sometimes used by itself off-label to treat cataplexy. Effexor XR is FDA-approved to treat:major depressive disorder (sometimes simply called depression)generalized anxiety disordersocial anxiety disorderpanic disorder
Drug forms and administration
Xyrem comes as a liquid solution. It’s taken at bedtime and then again 2.5 hours to 4 hours later.
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Xyrem makes you sleepy very quickly, so it should only be taken at bedtime. Effexor XR comes as capsules that are taken by mouth once daily. It’s usually taken in the morning.
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Side effects and risks
Xyrem and Effexor XR both contain drugs that are used to treat cataplexy. Therefore, these medications can cause very similar side effects.
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Below are examples of these side effects. Mild side effects
These lists contain examples of mild side effects that can occur with Xyrem, with Effexor XR, or with both drugs (when taken individually).Can occur with Xyrem:bedwettingCan occur with Effexor XR:constipationsexual problems, such as erectile dysfunction (difficulty having or keeping an erection) or decreased libido (reduced sex drive)loss of appetiteabnormal dreamsinsomnia (trouble sleeping)increased heart rateCan occur with both Xyrem and Effexor XR:nauseafeeling sleepy or drowsydry mouthsweatingvomitingtremordizziness
Serious side effects
These lists contain examples of serious side effects that can occur with Xyrem, with Effexor XR, or with both drugs (when taken individually).Can occur with Xyrem:misuse (sometimes called abuse)*central nervous system (CNS) depression (reduced function of your brain),* which may cause slowed breathingsleepwalkingCan occur with Effexor XR:serotonin syndrome (a dangerous condition that’s caused by a buildup of serotonin in your body)increased blood pressureabnormal bleedingseizureslung problems, including pneumoniaCan occur with both Xyrem and Effexor XR:mental changes, such as depression or thoughts of suicidesevere allergic reaction * Xyrem has boxed warnings from the FDA regarding the risks of CNS depression and drug misuse. A boxed warning is the strongest warning the FDA requires.
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It alerts doctors and patients about drug effects that may be dangerous. See “Xyrem side effects” above for details.
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Effectiveness
Xyrem and Effexor XR have different FDA-approved uses. While Xyrem is approved to treat narcolepsy by reducing cataplexy and EDS, Effexor XR is prescribed off-label to treat cataplexy.
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(With off-label use, a drug that’s approved to treat certain conditions is prescribed to treat a different condition.)
These drugs haven’t been directly compared in clinical trials. But separate studies have found both Xyrem and Effexor XR to be effective in treating cataplexy.
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Keep in mind though that current treatment guidelines recommend Effexor XR for people who either aren’t able to take Xyrem or didn’t improve with Xyrem in the past. Costs
Xyrem and Effexor XR are both brand-name drugs. There is a generic form of Effexor XR available called venlafaxine extended release.
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A generic drug is an exact copy of the active drug in a brand-name medication. The generic is considered to be just as safe and effective as the original drug. Brand-name medications usually cost more than generics.
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Xyrem is more expensive than either brand-name Effexor XR or its generic form, venlafaxine extended-release. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use. Xyrem and alcohol
If you drink alcohol, you should not drink it while taking Xyrem.
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Drinking alcohol during Xyrem treatment can increase your risk of central nervous system (CNS) depression. With CNS depression, you have slowed function of your brain.
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Symptoms of CNS depression can be severe and may include slow or weak breathing, low blood pressure, sleepiness, and passing out. And rarely, CNS depression may even lead to death. If you’d like to drink alcohol, and you need treatment for narcolepsy, talk with your doctor about treatment options other than Xyrem.
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Xyrem interactions
Xyrem can interact with several other medications. It is not known to interact with supplements, nor is it known to interact with any foods.
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Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe.
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Xyrem and other medications
Below are lists of medications that can interact with Xyrem. These lists do not contain all the drugs that may interact with Xyrem. Before taking Xyrem, talk with your doctor and pharmacist.
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Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.
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If you have questions about drug interactions that may affect you, ask your doctor or pharmacist. Xyrem and central nervous system depressants
Xyrem belongs to a class of drugs called central nervous system (CNS) depressants. Taking Xyrem along with other CNS depressants can cause very serious side effects.
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These side effects include slow heart rate, loss of consciousness, and slowed breathing. Usually, CNS depressants are used to improve sleep or treat anxiety. Examples of CNS depressants that should not be taken while you’re using Xyrem include:certain medications used to treat anxiety, such as:diazepam (Valium)lorazepam (Ativan)alprazolam (Xanax)clonazepam (Klonopin)certain medications used to treat insomnia, such as:zaleplon (Sonata)zolpidem (Ambien)eszopiclone (Lunesta)certain opioids (strong pain relievers), such as oxycodonegeneral anestheticscertain antidepressants, such as:doxepin (Silenor)mirtazapine (Remeron)trazodone (Desyrel)certain antipsychotics, such as:chlorpromazineclozapine (Clozaril)certain seizure medications, such as:carbamazepine (Tegretol)divalproex sodium (Depakote)phenobarbitalmuscle relaxants, such as cyclobenzaprineillegal CNS depressants, such as heroin or gamma-hydroxybutyrate (GHB)
If you’re taking a CNS depressant, talk with your doctor before starting Xyrem.
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They can help determine whether it’s safe for you to take Xyrem with other medications. Xyrem and divalproex sodium
Taking Xyrem along with the seizure drug divalproex sodium (Depakote) can increase the level of Xyrem in your body.
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This may increase your risk of certain side effects of Xyrem. If you need to take both Xyrem and divalproex sodium, your doctor may reduce your dosage of Xyrem.
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Talk with your doctor if you’re taking or planning to take divalproex sodium. Xyrem and herbs and supplements
There aren’t any herbs or supplements that have been specifically reported to interact with Xyrem. However, you should still check with your doctor or pharmacist before using any of these products while taking Xyrem.
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Xyrem and foods
There aren’t any foods that have been specifically reported to interact with Xyrem. If you have any questions about eating certain foods with Xyrem, talk with your doctor. Xyrem and pregnancy
It’s not known if Xyrem is safe to take while you’re pregnant.
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In an animal trial, Xyrem didn’t cause any problems with fetal development when it was given to pregnant females. However, the pregnancies did have an increased risk of stillbirth, reduced birth weight gain, and decreased survival after birth.
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But keep in mind that animal studies don’t always predict what will happen in people. If you’re pregnant or planning to become pregnant, talk with your doctor before starting Xyrem. Xyrem and birth control
It’s not known if Xyrem is safe to take during pregnancy.
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If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Xyrem. Xyrem and breastfeeding
It’s not known if Xyrem is safe to take while you’re breastfeeding.
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Gamma hydroxybutyrate (GHB) passes into breast milk when Xyrem is taken by a person who’s lactating. (Xyrem is a form of GHB.) It’s not known what effect either Xyrem or GHB may have on a child who’s breastfed.
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Talk with your doctor about whether it’s safe for you to take Xyrem while breastfeeding. How Xyrem works
Xyrem is approved to treat narcolepsy (a sleep disorder that makes you extremely sleepy).
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It treats this condition by decreasing excessive daytime sleepiness (EDS) and reducing cataplexy (sudden muscle weakness or paralysis). Xyrem increases the amount of time that you spend in deep sleep when you’re resting.
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This helps to decrease sleepiness when you’re awake. Xyrem belongs to a class of medications called central nervous system (CNS) depressants. It’s not known for sure how Xyrem works in your body to treat narcolepsy.
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However, it’s thought that Xyrem decreases both cataplexy and EDS by affecting certain chemicals (called neurotransmitters) inside your brain. How long does it take to work
Xyrem begins working right away after you take it.
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In fact, it can work very quickly in some people, helping them to fall asleep within 5 minutes after taking their dose. For most people, the drug helps them to fall asleep within 15 minutes after taking it. Xyrem cost
As with all medications, the cost of Xyrem can vary.
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The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use. It’s important to note that you’ll have to get Xyrem at a specialty pharmacy. This type of pharmacy is authorized to carry specialty medications.
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These are drugs that may be expensive or may require help from healthcare professionals to be used safely and effectively. Your insurance plan may require you to get prior authorization before approving coverage for Xyrem. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug.
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The insurance company will review the request and let you and your doctor know if your plan will cover Xyrem. If you’re not sure if you’ll need to get prior authorization for Xyrem, contact your insurance company.
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Financial and insurance assistance
If you need financial support to pay for Xyrem, or if you need help understanding your insurance coverage, help is available. Jazz Pharmaceuticals, Inc., the manufacturer of Xyrem, offers insurance and reimbursement support, the Xyrem Coupon Program, and the Xyrem Patient Assistance Program. For more information and to find out if you’re eligible for support, call 866-997-3688 or visit the program website.
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How to take Xyrem
It’s important to take Xyrem according to your doctor’s or healthcare professional’s instructions. When it’s not taken as prescribed, Xyrem can cause cravings. It can also cause dependence (when your body needs the drug in order to feel like usual) and tolerance (when you need to take more medication to have the same effect over time).
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These conditions can each lead to misuse of the drug. Before taking Xyrem, the medication needs to be diluted (mixed) with water. The manufacturer of Xyrem has provided step-by-step instructions that review how to prepare each dose of the drug, for yourself or for your child.
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Your daily Xyrem dose will be divided up into two doses. You’ll take one dose at bedtime, and one dose a few hours later. You should prepare both of your Xyrem doses before you go to bed.
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This way, when you wake up to take your second dose, you can just drink the dose and go right back to sleep. Once you dilute Xyrem, the prepared medication is only good for up to 24 hours. If you don’t take a diluted dose within 24 hours of preparing it, you’ll need to throw it away.
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Diluting your dose
When you pick up Xyrem from your pharmacy, you’ll receive two empty containers along with the medication. You’ll use these empty containers when you’re ready to dilute your doses of Xyrem.
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For example, when diluting a dose, start by measuring out about 1/4 cup of water into each of the empty containers. Then measure out your doses of Xyrem using a syringe.
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(This is done by placing the syringe into the center opening of the Xyrem bottle and pulling back on the syringe stopper to measure the correct amount.)
Next, place the measured amount of Xyrem into each container that’s holding the water you previously measured. Lastly, place the caps back onto the containers holding the diluted medication to safely store the drug until it’s time to take it. When to take
Xyrem should be taken at your bedtime and at least 2 hours after you’ve eaten food.
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A second dose of Xyrem should be taken 2.5 hours to 4 hours after you took your first dose. When you’re ready to take your first dose of Xyrem, drink the medication while you’re sitting in bed.
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Then lay down right away after taking the dose. This is important to do because you may become sleepy very quickly. In fact, during clinical trials, some people using Xyrem fall asleep within 5 minutes after taking their dose.
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Most people taking the medication fall asleep within 15 minutes of taking their dose. You may want to set an alarm to wake you up for your second dose of Xyrem.
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You should take the second dose 2.5 hours to 4 hours after you took the first dose. And you’ll take it in the same way as you took the first dose. To help make sure that you don’t miss a dose, try setting reminders on your phone.
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A medication timer may be useful, too. Taking Xyrem with food
You shouldn’t take Xyrem with food. Having food in your stomach can affect how well Xyrem is absorbed into your body.
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This may also affect how well the medication works for you. It’s recommended that you wait at least 2 hours after you’ve eaten before taking your doses of Xyrem.
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Xyrem precautions
This drug comes with several precautions. FDA warnings
This drug has boxed warnings.
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A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about drug effects that may be dangerous.
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It’s important to note that due to the risks described below, Xyrem can only be prescribed through a Risk Evaluation Mitigation Strategy (REMS) program. This means only certain doctors and pharmacies are able to prescribe and dispense this medication. See “REMS program” under “What is Xyrem ” above for details.
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Central nervous system depression. Xyrem is a central nervous system (CNS) depressant.
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This means that it works by relaxing your central nervous system, including muscles that help you breathe. With CNS depression, your CNS function slows down, which can be dangerous.
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Sometimes this can cause respiratory depression (slow, weak breathing), which can be life threatening. Symptoms can include slowed or trouble breathing, low blood pressure, or feeling sleepy, drowsy, fainting or dizzy. If you have any of these symptoms while taking Xyrem, call your doctor right away.
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See “Central nervous system depression” in the “Xyrem side effects” section above for details. Drug misuse.
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It’s possible to misuse Xyrem. This medication can sometimes cause dependence.
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(With dependence, your body needs the drug in order for you to feel like usual.) It’s also possible to build up a tolerance to Xyrem. (With tolerance, you feel like you need to take more and more of the drug to have the same effect over time.) Either of these conditions may lead to misuse of Xyrem (which is also called abuse). Keep Xyrem in a safe place to prevent misuse.
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If you take too much Xyrem, call your doctor right away, or call 911 (or your local emergency number) if your symptoms feel life threatening. For details about this warning, see “Misuse” in the “Xyrem side effects” section above. Other precautions
Before taking Xyrem, talk with your doctor about your health history.
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Xyrem may not be right for you if you have certain medical conditions or other factors affecting your health. These include:Depression or suicidal thoughts.
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Xyrem may increase your risk of depression or thoughts of suicide. If you have a history of depression or suicidal thoughts, your doctor may monitor you more carefully than usual during Xyrem treatment.
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If you feel depressed, have changes in your mood, or have thoughts of suicide, call your doctor right away.Heart failure. If you have heart failure, talk with your doctor before taking Xyrem. Xyrem contains a high amount of salt.
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People with heart failure may be on a low salt (sodium restricted) diet. This means Xyrem might not be safe for them to take.
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If you have heart failure, talk with your doctor before starting this drug.High blood pressure. Xyrem contains a high amount of salt, which may cause increased blood pressure.
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If you have high blood pressure or you’re on a low salt diet, be sure to include your Xyrem dose in your daily sodium intake. (Each gram [g] of the drug contains about 183 milligrams [mg] of sodium.) If you have high blood pressure, talk with your doctor before taking Xyrem.Decreased kidney function. Xyrem contains a high amount salt, which can worsen your kidney function if you already have certain kidney issues.
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If you’re on a low salt diet, it’s important to include your Xyrem doses in your salt daily intake. (Each gram of the drug contains about 183 mg of sodium.) If you have reduced kidney function, talk with your doctor before taking Xyrem.Pregnancy. It’s not known if Xyrem is safe to take during pregnancy.
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If you’re pregnant or planning to become pregnant, talk with your doctor before taking Xyrem. For more information, please see the “Xyrem and pregnancy” section above.Breastfeeding.
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It’s not known if Xyrem is safe to take during pregnancy. If you are breastfeeding, talk with your doctor before taking Xyrem. For more information, please see the “Xyrem and breastfeeding” section above.
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Note: For more information about the potential negative effects of Xyrem, see the “Xyrem side effects” section above. Xyrem overdose
Using more than the recommended dosage of Xyrem can lead to serious side effects. Do not use more Xyrem than your doctor recommends.
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In clinical trials of Xyrem, two cases of overdose occurred. One of these cases involved more than 15 times the maximum recommended dose. This caused the person to become unresponsive and to have trouble breathing.
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They recovered without further problems. The second case of overdose involved more than the recommended dose of Xyrem, and other drugs.
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This overdose was fatal. Overdose symptoms
The following symptoms were reported in clinical trials as possible symptoms of gamma-hydroxybutyrate (GHB) overdose.
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Keep in mind that while GHB is an illegal drug, Xyrem is a form of GHB that’s approved for medical use. Symptoms of overdose caused by GHB can include:confusionvomitingsweatingheadacheslower thoughts and movements than usualblurry visioncomaseizuresslowed breathingdecreased heart ratedecreased body temperatureunconsciousness
What to do in case of overdose
If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use its online tool.
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But if your symptoms are severe, call 911 or go to the nearest emergency room right away. Xyrem expiration storage and disposal
When you get Xyrem from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically 1 year from the date they dispensed the medication.
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However, after you dilute your doses of Xyrem, they should be used within 24 hours. The expiration date helps guarantee that the medication is effective during this time.
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The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk with your pharmacist about whether you might still be able to use it.
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Storage
How long a medication remains good can depend on many factors, including how and where you store the medication. Xyrem should be stored in its original bottle until you’re ready to prepare and take your doses. After preparing your doses, you’ll store the diluted drug in containers given to you at your pharmacy.
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For more information about diluting Xyrem, see the section “How to take Xyrem” above. Once you prepare diluted doses of Xyrem, they must be used within 24 hours.
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If you don’t take the doses within 24 hours, you’ll need to throw them away. Whether the drug is kept in its bottle or other storage containers, it should be stored with child-safe caps. This medication should be stored at room temperature (about 77°F/25°C) in a tightly sealed container away from light.
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Avoid storing this medication in areas where it could get damp or wet, such as in bathrooms. Disposal
If you no longer need to take Xyrem and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident.
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It also helps keep the drug from harming the environment. The recommended way to dispose of unused Xyrem is to pour it down a sink drain or toilet.
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The FDA website provides several useful tips on medication disposal. You can also ask your pharmacist for information on how to dispose of your medication.
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Professional information for Xyrem
The following information is provided for clinicians and other healthcare professionals. Indications
Xyrem is indicated for use in adults and children ages 7 and older with either cataplexy or excessive daytime sleepiness (EDS) related to narcolepsy. Mechanism of action
Xyrem works as a central nervous system (CNS) depressant.
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It is the salt form of gamma-hydroxybutyrate (GHB), which is a metabolite of GABA as well as an endogenous chemical. The exact mechanism of action of Xyrem is not known. However, it is believed that Xyrem works through the GABA-B receptor at noradrenergic and dopaminergic neurons.
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It also may work at thalamocortical neurons. In this way, it is believed that Xyrem treats narcolepsy by decreasing both cataplexy and excessive daytime sleepiness (EDS).
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Pharmacokinetics and metabolism
The pharmacokinetics of GHB, of which Xyrem is the salt form, are nonlinear. The average time to peak plasma concentration was between 30 minutes and 1.25 hours. After a high-fat meal, absorption was delayed.
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The major metabolism pathway for GHB is the Krebs cycle, in which carbon dioxide and water are produced. Through this pathway, GHB hydrogenase catalyzes the conversion of GHB to succinic semialdehyde.
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This compound is then transformed into succinic acid through succinic semialdehyde dehydrogenase. Succinic acid then goes through the Krebs cycle where the final products, water and carbon dioxide, are created. A transhydrogenase enzyme also converts succinic semialdehyde.
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The secondary metabolism pathway for GHB is beta-oxidation. This occurs through 3,4-dihydroxybutyrate, which converts GHB into carbon dioxide and water.
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GHB is mostly cleared from the body as carbon dioxide, which is breathed out. Six to eight hours post-dose, less than 5% of the drug is eliminated in the urine. The half-life of GHB is between 30 minutes and 1 hour.
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Contraindications
Xyrem is contraindicated for use in people with succinic semialdehyde dehydrogenase deficiency. This deficiency is a rare disorder; however, it causes decreased metabolism of Xyrem in the body, which can cause accumulation. Xyrem is also contraindicated for use in people who are taking either other sedative-hypnotics or alcohol.
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This increases the risk of CNS depression as well as respiratory depression. Misuse and dependence
Xyrem has the potential to cause dependence.
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This can lead to misuse of the drug. GHB (of which Xyrem is the salt form) is an illegal Schedule I controlled substance that can cause dependence.
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Dependence can lead to misuse (sometimes called abuse). Misuse is associated with seizures, respiratory depression, loss of consciousness, coma, and death. It is important to monitor people taking Xyrem for signs of dependence or misuse.
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The REMS program for Xyrem should be followed when prescribing and dispensing this drug. Storage
Xyrem should be stored in its original bottle or pharmacy containers.
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Child-resistant caps should be in place on the bottles. This medication should be stored at room temperature (77°F/25°C) in a tightly sealed container away from light. Avoid storing this medication in areas where it could get damp or wet, such as in bathrooms.
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Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication.
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The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.Pharmacy / PharmacistSleep / Sleep Disorders / InsomniaDrugsMedically reviewed by Tanya Kertsman, PharmD — By Jennifer Mitri Williamson, Pharm.D. — Updated on August 5, 2022
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