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Generic name: sodium oxybate

What is Xyrem?

Xyrem is a prescription medicine used to treat the following symptoms in people 7 years of age or older with narcolepsy:

  • sudden onset of weak or paralyzed muscles (cataplexy)
  • excessive daytime sleepiness (EDS)

It is not known if Xyrem is safe and effective in children less than 7 years of age.

What is the most important information I should know about Xyrem?

  • Xyrem is a central nervous system (CNS) depressant. Taking Xyrem with other CNS depressants such as medicines used to make you or your child fall asleep, including opioid analgesics, benzodiazepines, sedating antidepressants, antipsychotics, sedating anti-epileptic medicines, general anesthetics, muscle relaxants, alcohol, or street drugs, may cause serious medical problems, including:
    • trouble breathing (respiratory depression)
    • low blood pressure (hypotension)
    • changes in alertness (drowsiness)
    • dizziness (syncope)
    • death
  • Xyrem is a federal controlled substance (CIII). The active ingredient of Xyrem is a form of gamma-hydroxybutyrate (GHB) that is also a federal controlled substance (CI). Abuse of illegal GHB, either alone or with other CNS depressants may cause serious medical problems, including:
    • seizure
    • trouble breathing (respiratory depression)
    • changes in alertness (drowsiness)
    • coma
    • death
      Call your doctor right away if you or your child has any of these serious side effects. Ask your doctor if you are not sure if you are taking a medicine listed above.
  • Anyone who takes Xyrem should not do anything that requires them to be fully awake or is dangerous, including driving a car, using heavy machinery, or flying an airplane, for at least 6 hours after taking Xyrem. Those activities should not be done until you know how Xyrem affects you or your child.
  • Keep Xyrem in a safe place to prevent abuse and misuse. Selling or giving away Xyrem may harm others, and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
  • Because of the risk of CNS depression, abuse, and misuse Xyrem is available only by prescription and filled through the central pharmacy in the Xyrem REMS Program. Before you receive or your child receives Xyrem, your doctor or pharmacist will make sure that you understand how to take Xyrem safely and effectively. If you have any questions about Xyrem, ask your doctor or call the Xyrem REMS Program at 1-866-997-3688.

Who should not take Xyrem?

Do not take XYREM if you or your child:

  • takes other sleep medicines or sedatives (medicines that cause sleepiness)
  • drinks alcohol
  • has a rare problem called succinic semialdehyde dehydrogenase deficiency

What should I tell my healthcare provider before taking Xyrem?

Before taking Xyrem, tell your doctor about all medical conditions, including if you or your child:

  • have short periods of not breathing while sleeping (sleep apnea)
  • snores, has trouble breathing, or has lung problems. You or your child may have a higher chance of having serious breathing problems when taking Xyrem.
  • have or had depression or has tried to harm yourself or themselves. You or your child should be watched carefully for new symptoms of depression.
  • has or had behavior or other psychiatric problems such as:
    • anxiety
    • feeling more suspicious (paranoia)
    • acting aggressive
    • seeing or hearing things that are not real (hallucinations)
    • being out of touch with reality (psychosis)
    • agitation
  • have liver problems
  • are on a salt-restricted diet. Xyrem contains a lot of sodium (salt) and may not be right for you or your child.
  • have high blood pressure
  • have heart failure
  • have kidney problems
  • are pregnant or plan to become pregnant. It is not known if Xyrem can harm unborn babies.
  • are breastfeeding or plan to breastfeed. Xyrem passes into breast milk. You and your doctor should decide if you or your child will take Xyrem or breastfeed.

Tell your doctor about all the medicines you take or your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially, tell your doctor if you take or your child takes other medicines to help you sleep (sedatives). Know the medicines you take or your child takes. Keep a list of them to show your doctor and pharmacist when you or your child gets a new medicine.

How should I take Xyrem?

  • Read the Instructions for Use that come with Xyrem on how to take Xyrem.
  • Take or give Xyrem exactly as your doctor tells you to take or give it.
  • Xyrem can cause physical dependence and craving for the medicine when it is not taken as directed.
  • Never change the Xyrem dose without talking to your doctor.
  • Xyrem can cause sleep very quickly without feeling drowsy. Some patients fall asleep within 5 minutes and most fall asleep within 15 minutes. Some patients take less time to fall asleep and some take more time. The time it takes to fall asleep might be different from night to night.
  • Falling asleep quickly, including while standing or while getting up from the bed, has led to falls with injuries that have required some people to be hospitalized.
  • Xyrem is taken at night divided into 2 doses.
    • Adults: Take the first Xyrem dose at bedtime while you are in bed and lie down immediately. Take the second Xyrem dose 2½ to 4 hours after the first Xyrem dose. You may want to set an alarm clock to make sure you wake up to take the second Xyrem dose. You should remain in bed after taking the first and second doses of Xyrem.
    • Child: Give the first Xyrem dose at bedtime or after an initial period of sleep, while your child is in bed and have them lie down immediately. Give the second Xyrem dose 2½ to 4 hours after the first Xyrem dose. You may want to set an alarm clock to make sure you wake up to give the second Xyrem dose. Your child should remain in bed after taking the first and second doses of Xyrem.
  • If you miss or your child misses the second Xyrem dose, skip that dose and do not take or give Xyrem again until the next night. Never take or give 2 Xyrem doses at 1 time.
  • Wait at least 2 hours after eating before taking Xyrem.
  • You or your child should see your doctor every 3 months for a check-up while taking Xyrem. Your doctor should check to see if Xyrem is helping to lessen your or your child’s symptoms and if you feel or your child feels any side effects while taking Xyrem.
  • If you take or your child takes too much Xyrem, call your doctor or go to the nearest hospital emergency room right away.

What are the possible side effects of Xyrem?

Xyrem can cause serious side effects, including:

  • See “What is the most important information I should know about Xyrem?
  • breathing problems, including:
    • slower breathing
    • trouble breathing
    • short periods of not breathing while sleeping (sleep apnea). People who already have breathing or lung problems have a higher chance of having breathing problems when they use Xyrem.
  • mental health problems, including:
    • confusion
    • seeing or hearing things that are not real (hallucinations)
    • unusual or disturbing thoughts (abnormal thinking)
    • feeling anxious or upset
    • depression
    • thoughts of killing yourself or trying to kill yourself
      Call your doctor right away if you have or your child has symptoms of mental health problems.
  • sleepwalking. Sleepwalking can cause injuries. Call your doctor if you start or your child starts sleepwalking. Your doctor should check you or your child.

The most common side effects of Xyrem include:

  • nausea
  • sleepiness
  • dizziness
  • vomiting
  • bedwetting
  • tremor (in adults)

In pediatric patients, headache, decreased appetite, and weight decrease were also common.

Side effects may increase when taking higher doses of Xyrem.

These are not all the possible side effects of Xyrem. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Xyrem

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Xyrem for a condition for which it was not prescribed. Do not give Xyrem to other people, even if they have the same symptoms. It may harm them.

You can ask your pharmacist or doctor for information about XYREM that is written for health professionals.

How should I store Xyrem?

  • Store Xyrem in the original bottle or in pharmacy containers with child-resistant caps provided by the pharmacy.
  • Get emergency medical help right away if a child who has not been prescribed Xyrem drinks Xyrem. Store Xyrem between 68°F to 77°F (20°C to 25°C).
  • Xyrem solution prepared after dilution should be taken within 24 hours.
  • When you have finished using a Xyrem bottle:
    • empty any unused Xyrem down the sink drain
    • cross out the label on the Xyrem bottle with a marker
    • place the empty Xyrem bottle in the trash

Keep Xyrem and all medicines out of the reach of children and pets.

What are the ingredients in Xyrem?

Active ingredients: sodium oxybate

Inactive ingredients: purified water and malic acid

For more information, go to WWW.XYREMREMS.COM or call the XYREM REMS Program at 1-866-997-3688.

Source: National Library of Medicine. Last updated October 26, 2018.