Like most drugs, Xyrem may cause mild or serious side effects. The following lists describe some of the side effects that Xyrem may cause. These lists do not include all possible side effects.
Keep in mind that side effects of a drug can depend on:
your ageother health conditions you heother medications you takeYour doctor or pharmacist can tell you more about the potential side effects of Xyrem. They can also suggest ways to help reduce side effects.
Mild side effectsHere’s a short list of some of the mild side effects that Xyrem can cause. To learn about other mild side effects, talk with your doctor or pharmacist, or read Xyrem’s prescribing information.
Mild side effects of Xyrem reported in studies include:
a tingling or prickling sensation, typically in your arms, feet, hands, or legsbedwettingabdominal paindiarrheadifficulty concentrating or paying attentiondizzinessnausea or vomitingsleepinesstremorIn addition, the following mild side effects he been reported in children taking Xyrem:
decreased appetiteweight lossheadacheMild side effects of many drugs may go away within a few days to a couple of weeks. But if they become bothersome, talk with your doctor or pharmacist.
Serious side effectsSerious side effects from Xyrem can occur, but they are not common. If you he serious side effects from Xyrem, call your doctor right away. But if you think you’re hing a medical emergency, you should call 911 or your local emergency number.
Serious side effects of Xyrem that he been reported include:
anxietydepressionaggression or paranoiahallucinations (seeing or hearing something that’s not really there)psychosis (loss of contact with reality)suicidal thoughts or actionsboxed warnings: risk of misuserisk of central nervous system (CNS) depressionatypical dreams or unusual behiors during sleepbreathing problems, including sleep apneaallergic reactionFor more information about risk of misuse, see the “Can Xyrem be misused?” section. For more information about some of these other side effects, see the “Side effect focus” section.
Suicide preventionIf you think someone is at immediate risk of self-harm or hurting another person:
Call 911 or your local emergency number.Stay with the person until help arrives.Remove any guns, knives, medications, or other things that may cause harm.Listen, but don’t judge, argue, threaten, or yell.If you or someone you know is considering suicide, get help from a crisis or suicide prevention hotline. Try the National Suicide Prevention Lifeline at 800-273-8255.
Side effect focusLearn more about some of the side effects Xyrem may cause.
Boxed warningsXyrem has boxed warnings. A boxed warning is a serious warning from the Food and Drug Administration (FDA).
Risk of misuse: It’s possible to misuse Xyrem. (Misuse is sometimes called abuse.) Misuse of Xyrem can result in serious side effects, including coma or difficulty breathing. In rare cases, it can even be fatal.
To learn more, see the “Can Xyrem be misused?” section.
Risk of CNS depression: Xyrem depresses (slows down) activity in your CNS. This is called CNS depression. Even when you take Xyrem at doses prescribed by your doctor, the drug will cause this side effect. CNS depression can impair your motor skills, judgment, and thinking.
Due to the risk of CNS depression, you should not take Xyrem with alcohol. And you should not take Xyrem together with drugs called sedative hypnotics. These are a type of medication prescribed to treat certain sleep disorders.
In addition, combining Xyrem with other CNS depressants can lead to serious side effects, such as:
difficulty breathinglow blood pressuredrowsinessfaintingIn rare cases, taking Xyrem with other CNS depressants may be fatal.
For more about sedative hypnotics and CNS depressants, see the “What should be considered before taking Xyrem?” section.
What might help
Due to the risks of misuse and CNS depression, only certain healthcare professionals with special certification may prescribe Xyrem. And only a specially licensed pharmacy may fill Xyrem prescriptions.
These restrictions apply to Xyrem because the drug is prescribed under a program called a risk evaluation and mitigation strategy (REMS). The Food and Drug Administration (FDA) can require certain drugs to he a REMS so that they’re prescribed only when their benefits outweigh their risks. To learn more, see the “Can Xyrem be misused?” section.
Due to Xyrem’s effects on the CNS, certain activities can be dangerous after you take a dose of this drug. You should wait at least 6 hours after a dose before taking part in activities that require you to be fully awake. Examples include driving a car and operating machinery.
Breathing problems, including sleep apneaTreatment with Xyrem can cause breathing problems, including sleep apnea. If you he existing breathing problems or sleep apnea, taking Xyrem may worsen your condition.
Certain people may be at higher risk of breathing problems if they take Xyrem, including:
people with obesitymalesfemales who he gone through menopause and are not taking hormone therapyWith sleep apnea, your breathing stops and restarts while you’re sleeping. This side effect was rare in studies of Xyrem. But a few people in these studies had to stop taking Xyrem due to this side effect.
Symptoms of sleep apnea can include:
choking or gasping during sleephing a headache upon waking upsnoringfeeling tired after sleepingNote: The use of binary terms such as “male” and “female” or “men” and “women” in this article reflects the language of the sources we’ve used. Unless otherwise noted, it’s unclear whether the research we reference included participants with expansive gender identities.
What might help
If you notice symptoms of sleep apnea or breathing problems while taking Xyrem, talk with your doctor. You should also contact your doctor if you he an existing breathing problem that worsens while you’re taking Xyrem. They can best advise you on whether it’s safe for you to continue taking Xyrem. They can also recommend another treatment for your condition that may be better.
Atypical dreams or unusual behiors during sleepTaking Xyrem may cause you to he atypical dreams or unusual behiors during sleep. These were among Xyrem’s most common side effects in studies.
Examples of unusual behiors during sleep that the studies reported include:
sleepwalkingperforming tasks, such as chores, in your sleepeating in your sleeptalking in your sleepFor some people, these behiors he led to injury.
What might help
While you’re taking Xyrem, notify your doctor right away if you notice atypical dreams or unusual behiors during sleep. They’ll likely want to examine your symptoms further. Your doctor may recommend that you stop taking Xyrem and can discuss alternative treatments with you.
Allergic reactionSome people may he an allergic reaction to Xyrem. While allergic reaction was not reported in studies of the drug, it has occurred in rare cases since the drug became ailable on the market.
Symptoms of a mild allergic reaction can include:
skin rashitchinessflushing (temporary warmth, redness, or deepening of skin color)A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include swelling under your skin, typically in your eyelids, lips, hands, or feet. They can also include swelling of your tongue, mouth, or throat, which can cause difficulty breathing.
Call your doctor right away if you he an allergic reaction to Xyrem. But if you think you’re hing a medical emergency, call 911 or your local emergency number.