Pronunciation: Zie-rem
Generic name: sodium oxybate
Dosage form: oral solution
Drug class: Miscellaneous anxiolytics, sedatives and hypnotics

Medically reviewed by Carmen Pope, BPharm. Last updated on Sep 26, 2024.

What is Xyrem?

Xyrem (sodium oxybate) is an oral prescription solution that may be used to treat cataplexy (sudden loss of muscle tone) or excessive daytime sleepiness (EDS) in adults and children aged 7 years and older with narcolepsy.

Xyrem’s mechanism of action for narcolepsy is thought to involve binding to GABA_B and GHB receptors to enhance deep sleep at night, which helps to reduce EDS. The exact way Xyrem works is unknown (see How does Xyrem work for narcolepsy?). Xyrem belongs to the class of medicines known as central nervous system (CNS) depressants.

Xyrem contains sodium oxybate, also known as GHB, which is a known street drug of abuse. Because of the potential for abuse and serious side effects, Xyrem is available only from a certified pharmacy under a special program called Xywav and Xyrem REMS Program (see What is Xyrem REMS?). You and your healthcare provider must be registered in the program and understand the risks and benefits of this medicine.

Xyrem gained FDA approval on July 17, 2002. A Xyrem generic is available under the name sodium oxybate.

Xywav vs Xyrem

Xywav is a low-sodium alternative to Xyrem, approved in 2020 after concerns about the high sodium content of Xyrem potentially contributing to heart disease, high blood pressure, or kidney disease (see What is the difference between Xywav vs Xyrem?).

Lumryz vs Xyrem

Lumryz is an extended-release version of sodium oxybate taken once at night (see What is the difference between Lumryz vs Xyrem?). 

What schedule is Xyrem?

Xyrem has dual classification and is classified as a Schedule 3 controlled substance when used legitimately and a Schedule 1 controlled substance when misused (see Is Xyrem a controlled substance/narcotic drug of abuse?).

• When misused either by patients or by those obtaining it illegally, Xyrem is treated as a Schedule 1 substance which carries severe legal penalties such as imprisonment and heavy fines.

Xyrem side effects

The most common side effects of Xyrem in adults include:

• nausea
• sleepiness
• dizziness
• vomiting
• bedwetting
• tremor.

The most common side effects of Xyrem in children include:

• nausea
• weight decreased
• bedwetting
• decreased appetite
• vomiting
• dizziness
• headache
• sleepwalking.

Side effects may increase when taking higher doses of Xyrem.

Serious side effects and warnings

Xyrem carries a Boxed Warning for CNS depression, abuse and misuse.

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)
• fainting (syncope)
• death.

Ask your doctor if you are not sure if you are, or your child is, taking one of the medicines listed above.

Xyrem is a federal controlled substance (CIII). The active ingredient of Xyrem is a form of gamma-hydroxybutyrate (GHB) that is also a federally controlled substance (CI). Abuse of illegal GHB, either alone or with other CNS depressants may cause serious medical problems, including:

• seizures
• 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.

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.

Xyrem may cause breathing problems, such as

• slower breathing
• trouble breathing
• short periods of not breathing while sleeping (sleep apnea).

People with breathing or lung problems have a higher chance of breathing problems when they take Xyrem.

Mental health problems have been reported with Xyrem, 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
• increased tiredness
• feelings of guilt or worthlessness
• difficulty concentrating.

Call your doctor right away if you have or your child has symptoms of mental health problems, or a change in weight or appetite.

Xyrem can cause sleepwalking which may lead to injuries. Call your doctor if you start or your child starts sleepwalking. Your doctor should check you or your child.

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 the FDA at 1-800-FDA-1088.

Before taking

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.

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

• have a history of drug abuse.
• have short periods of not breathing while sleeping (sleep apnea)
• 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 have 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, seeing or hearing things that are not real (hallucinations), feeling more suspicious (paranoia), being out of touch with reality (psychosis), acting aggressively, or agitated
• has 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
• has heart failure
• has kidney problems
• is pregnant or planning to become pregnant
• is breastfeeding or planning to breastfeed.

Pregnancy

It is not known if Xyrem can harm your unborn baby.

Breastfeeding

Xyrem passes into breast milk. You and your doctor should decide if you or your child will take Xyrem or breastfeed.

How should I take or give Xyrem?

Read the Instructions for Use in the Xyrem Package Insert for detailed instructions 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 is taken at night split into 2 doses. Prepare both doses of Xyrem before bedtime; dilute each dose with approximately ¼ cup of water in pharmacy-provided containers

• You should wait at least 2 hours after eating before taking or giving Xyrem.
• Take each dose while in bed and lie down after dosing.
• Xyrem can cause sleep very quickly without feeling drowsy. Some people fall asleep within 5 minutes and most fall asleep within 15 minutes. 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.

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.

Children: 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.

Xyrem dosage

The recommended starting dosage in people with liver disease is one-half of the original dosage per night administered orally, divided into two doses.

Xyrem dosage for adults with narcolepsy

• Initially: Xyrem 2.25 g at bedtime and 2.25 g taken 2.5 to 4 hours later.
• Increase the dosage by 1.5 g per night at weekly intervals to the effective dose range of 6 g to 9 g per night (split into 2 doses).
• Maximum dosage: 9 g at night (split into 2 doses)

Xyrem dosage for children with narcolepsy

• The dosage of Xyrem for children is based on body weight. See the Xyrem Prescribing information for the full recommended Pediatric dosages for Xyrem.

Related/similar drugs

Xywav, Adderall, methylphenidate, Ritalin, Concerta, modafinil, dextroamphetamine, sodium oxybate, Lumryz, calcium oxybate / magnesium oxybate / potassium oxybate / sodium oxybate

What happens if I miss a dose?

If you 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.

What happens if I take too much Xyrem?

If you or your child takes too much Xyrem, call your doctor or go to the nearest hospital emergency room right away.

Xyrem REMS

Because of the risk of CNS depression, abuse, and misuse, Xyrem can only be prescribed by healthcare providers enrolled in the Xywav and Xyrem REMS Program.

Before prescribing your healthcare provider will screen you for alcohol or substance abuse or other medical conditions that may prohibit the use of Xyrem. They should also provide you with an Xyrem REMS Program Patient Quick Start Guide. You will also need to complete a one-time enrollment in the Xywav and Xyrem REMS Program Patient Enrollment Form and be able to answer patient questions about usage, storage, the risks associated with Xyrem, and where to obtain it from.

The prescription for Xyrem can only be filled by the central certified pharmacy, not your local pharmacy. This is the only pharmacy in the United States permitted to fill the prescription and send it directly to patients. This pharmacy also allows the patient access to a pharmacist 24 hours a day, 7 days a week to answer questions about Xyrem; provides an overnight delivery service (includes Saturdays) - but only the patient or a designated adult can sign for delivery, and follows up your prescription with a nurse case manager two days after delivery who can answer any questions.

For information on how to receive Xyrem ask your healthcare provider, visit www.xywavxyremrems.com, or call Xywav and Xyrem REMS Program on 1-866-997-3688.

What other medicines will affect Xyrem?

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

Xyrem should not be taken in combination with sedative hypnotics or with alcohol.

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

Xyrem storage

Store Xyrem in the original bottle before mixing it with water. After mixing with water, store Xyrem in pharmacy containers with child-resistant caps provided by the pharmacy.

Store Xyrem at room temperature between 68°F to 77°F (20°C to 25°C).

Xyrem solution prepared after mixing with water 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.

Xyrem comes in a child-resistant package. Keep Xyrem and all medicines out of the reach of children and pets.

Xyrem ingredients

Active ingredients: sodium oxybate 0.5 g per mL (0.5 g/mL of sodium oxybate equivalent to 0.413 g/mL of oxybate).

Inactive ingredients: purified water and malic acid.

Available as Xyrem oral solution, 0.5 g per mL, in a 180 mL bottle with a child-resistant cap.

Who makes Xyrem?

Jazz Pharmaceuticals, Inc. makes Xyrem.

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