Side effects, use for narcolepsy, dosage, etc.

Like most medicines, Xyrem can cause mild or severe side effects. The lists below describe some of the more common side effects that Xyrem can cause. These lists do not include all possible side effects.

Keep in mind that the side effects of a medicine can depend on:

  • your age
  • other health problems you have
  • other medicines you are taking

Your 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 effects

Here is a short list of some of the mild side effects that Xyrem can cause. For more information about other mild side effects, talk to your doctor or pharmacist, or read the Xyrem package leaflet. prescribing information.

Mild Xyrem side effects that have been reported include:

Additionally, the following mild side effects have been reported in children using Xyrem:

Mild side effects of many medications can disappear within days to weeks. But if they become bothersome, talk to your doctor or pharmacist.

Serious side effects

Serious side effects from Xyrem can occur, but they are not common. If you have serious side effects from Xyrem, call your doctor right away. But if you think you have a medical emergency, you should call 911 or your local emergency number.

Serious Xyrem side effects that have been reported include:

* For more information on the risks of misuse, see “Can Xyrem be misused?” » section below.
† For more information on this side effect, see the “Focus on side effects” section below.

suicide prevention

If you think someone is at immediate risk of harming themselves or another person:

  • Dial 911 or your local emergency number.
  • Stay with the person until help arrives.
  • Remove any guns, knives, drugs, or other objects that could cause damage.
  • 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.

Focus on side effects

Learn more about some of the side effects Xyrem can cause.

Boxed warnings

Xyrem possesses framed warnings. A boxed warning is a serious warning from the Food and Drug Administration (FDA).

Risk of misuse. It is possible to abuse Xyrem. (Misuse is sometimes called abuse.) Misuse of Xyrem can cause serious side effects, including coma or difficulty breathing. In rare cases, it can even be fatal.

For more information, see “Can Xyrem be misused?” » section below.

Risk of CNS depression. Xyrem depresses (slows down) your CNS activity. This is called CNS depression. Even when you take Xyrem in the 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 shouldn’t take Xyrem with medicines called sedative hypnotics. It is a type of medication prescribed to treat certain sleep disorders.

Additionally, combining Xyrem with other CNS depressants can cause serious side effects, such as:

In rare cases, taking Xyrem with other CNS depressants can be fatal.

For more information on sedative hypnotics and CNS depressants, see “What to consider before taking Xyrem?” » section below.

What might help

Due to the risks of CNS misuse and depression, only certain healthcare professionals with special certification can prescribe Xyrem. And only a specially licensed pharmacy can fill prescriptions for Xyrem.

These restrictions apply to Xyrem because the drug is prescribed under a program called the Risk Assessment and Mitigation Strategy (REMS). The Food and Drug Administration (FDA) may require certain drugs to have REMS so that they are prescribed only when their benefits outweigh their risks. For more information, see “Can Xyrem be misused?” » section below.

Due to Xyrem’s effects on the CNS, some activities may be dangerous after taking a dose of this medication. 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 apnea

Treatment with Xyrem can cause breathing problems, including sleep apnea. If you already have breathing problems or sleep apnea, taking Xyrem may make your condition worse.

Some people may be at higher risk for breathing problems if they take Xyrem, including:

  • obese people
  • males*
  • women* who have gone through menopause and are not taking hormone replacement therapy

With sleep apnea, your breathing stops and starts again while you sleep. This side effect was rare in studies from Xyrem. But a few people in these studies had to stop taking Xyrem because of this side effect.

Symptoms of sleep apnea can include:

  • choking or gasping during sleep
  • having a headache when you wake up
  • snoring
  • feeling tired after sleeping

* In this article, we use the terms “male” and “female” to refer to the sex assigned to a person at birth. For more information on the difference between sex and gender, check out this article.

What might help

If you notice symptoms of sleep apnea or breathing problems while taking Xyrem, tell your doctor. You should also contact your doctor if you have an existing breathing problem that gets worse while taking Xyrem. They can better advise you on safety for you to continue using Xyrem. They may also recommend another treatment for your condition that might be better.

Abnormal dreams or unusual behaviors during sleep

Taking Xyrem may cause abnormal dreams or unusual behavior during sleep. These were among the most common side effects of Xyrem in studies.

Here are examples of unusual behaviors during sleep reported by studies:

  • somnambulism
  • performing tasks, such as chores, while you sleep
  • eat while sleeping
  • talk in your sleep

For some people, these behaviors have resulted in injury.

What might help

While taking Xyrem, tell your doctor right away if you notice any abnormal dreams or unusual behaviors while sleeping. They will probably want to examine your symptoms in more detail. Your doctor may recommend that you stop taking Xyrem and discuss alternative treatments with you.

Allergic reaction

Some people may have an allergic reaction to Xyrem. Although no allergic reactions have been reported in studies of the drug, this has happened in rare cases since the drug became available on the market.

Symptoms of a mild allergic reaction may include:

A more serious allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include swelling under the skin, usually on the eyelids, lips, hands or feet. They can also include swelling of the tongue, mouth, or throat, which can lead to difficulty breathing.

Call your doctor right away if you have an allergic reaction to Xyrem. But if you think you have a medical emergency, call 911 or your local emergency number.

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