Xyrem (sodium oxybate)
An approved treatment for Narcolepsy Type 1.
Drug facts
The same compound appears under different names depending on the context. Here is how to identify Sodium oxybate wherever you encounter it, plus the key facts at a glance.
- Generic name
- Sodium oxybate
- Brand name
- Xyrem
- Drug class
- Central nervous system depressant (oxybate)
- Manufacturer
- Jazz Pharmaceuticals
- How it's taken
- Liquid by mouth, mixed with water, in 2 doses each night
A liquid medicine taken in 2 doses each night, at bedtime and 2.5 to 4 hours later, for cataplexy or excessive daytime sleepiness in people 7 years and older with narcolepsy.
The FDA approved it for cataplexy in adults in 2002, and it later added daytime sleepiness and, in October 2018, children 7 and older. It carries a boxed warning for slowed breathing and dulled alertness and for abuse and misuse, is a Schedule III controlled substance, and is shipped only through a restricted program from 1 certified central pharmacy.
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Where Sodium oxybate fits
Xyrem (sodium oxybate) is a liquid taken in 2 doses each night for cataplexy or daytime sleepiness in people with narcolepsy aged 7 and older, and it was the first oxybate medicine approved for narcolepsy.
- Narcolepsy type 1 is also treated with daytime wake-promoting drugs such as modafinil, stimulants and Wakix (pitolisant), and since August 2026 Orzeyful, which acts on orexin receptors.
- Xywav and Lumryz contain the same active part, oxybate; Xywav uses a mix of salts with less sodium, and Lumryz is taken once a night.
- No trial has compared Xyrem head to head with Xywav, Lumryz or the daytime medicines, since its trials used placebo.
- A question to bring to a sleep specialist is how the nightly sodium load and any sedating medicines fit with a person's other health conditions.
How Sodium oxybate works
Narcolepsy type 1 is caused by the loss of brain cells that make orexin (also called hypocretin), a chemical messenger that keeps people awake and stabilizes muscle tone, which leads to daytime sleepiness, cataplexy (sudden muscle weakness set off by strong emotions) and broken nighttime sleep. Sodium oxybate is the sodium salt of gamma-hydroxybutyrate (GHB), a substance that acts on GABA-B receptors, which calm nerve activity. The label says it is thought to work through those receptors, but how it improves narcolepsy symptoms is unknown[1].
Side effects and safety
- Slowed breathing and other drugs that slow the brain. The label says not to combine it with alcohol or sedative sleep medicines. Opioids, benzodiazepines, sedating antidepressants or antipsychotics, sedating seizure medicines and muscle relaxants raise the risk of slowed breathing, low blood pressure, deep sedation and death. The label says not to drive or do hazardous work for at least 6 hours after a dose.
- Sleep apnea and breathing during sleep. Pauses in breathing and drops in oxygen during sleep have been seen in adults and children.
- Depression and suicidal thoughts. Among 781 adults in trials, 7% reported depression and there were 2 suicides and 2 suicide attempts. New or worse mood changes should be reported right away.
- Confusion, anxiety and sleepwalking. Confusion in 3% overall and sleepwalking in 6% of adults in trials.
- High sodium. About 550mg of sodium a night at 3g, 1100mg at 6g and 1640mg at 9g, which matters for people with heart failure, high blood pressure or kidney problems.
- Dispensed only through the XYWAV and XYREM REMS, 1-866-997-3688
- Tell your doctor about every medicine, especially opioids, benzodiazepines and other sedating drugs
- Divalproex (a seizure and mood medicine) raises oxybate levels, so the Xyrem dose is lowered by at least 20% when both are used
- Report mood changes, confusion or breathing problems during sleep
Xyrem has a boxed warning. It slows the brain and breathing, and in trials at recommended doses some adults had dulled alertness and slowed breathing. It is the sodium salt of GHB, and illegal GHB abuse has been linked to seizures, slowed breathing, coma and death, so Xyrem is available only through the XYWAV and XYREM REMS program.
The label says it must not be combined with alcohol or sedative sleep medicines, and other drugs that slow the brain, such as opioids and benzodiazepines, raise the risk of dangerous breathing problems. The label also says people should not drive or do hazardous work for at least 6 hours after a dose.
In adult trials, side effects seen in at least 5% of people and at least twice as often as on placebo were nausea (up to 20% at 9g against 3%), dizziness (up to 15% against 4%), vomiting (up to 11% against 1%), sleepiness, bedwetting (up to 7% against 1%) and tremor. Side effects led 10.3% of adults to stop, against 2.8% on placebo.
In children the most common were nausea (20%), bedwetting (19%), vomiting (18%) and headache (17%). Other warnings cover depression and suicidal thoughts, confusion and anxiety, sleepwalking and high sodium, about 1640mg a night at 9g[1].
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Sodium oxybate
Both nightly doses are prepared before bed, each mixed with about 1/4 cup (60mL) of water. The first is taken in bed at least 2 hours after eating, and the second 2.5 to 4 hours later; people lie down right away and often fall asleep within 5 minutes. Adults start at 4.5g a night split into 2 doses and go up by 1.5g a night each week to 6g to 9g a night; doses above 9g have not been studied.
Children 7 and older are dosed by weight, from 20kg up, with a lower starting dose and a lower maximum for lighter children; the label has no dose for children under 20kg. People with liver impairment start at half the usual dose, and the dose is lowered by at least 20% when divalproex is started. A missed second dose is skipped, and the 2 doses are never taken together[1].
Availability and cost
Only available as the brand-name product.
Help paying for Xyrem
With private insurance, the drugmaker's copay card can lower what you pay for Xyrem. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE, but charity funds often can. Of the 4 charity funds for Narcolepsy Type 1, 3 were open on October 26, 2026. Without insurance, you can apply to the drugmaker's free medicine program, which sets its own eligibility rules. Pick your insurance below to see which offers fit you.
- Copay help
Eligible patients can pay as little as $35 for a 30-day fill of Xyrem, subject to monthly and annual maximum benefits. Not valid for Medicare, Medicaid, VA or other federal or state healthcare programs, or for cash payers.
For: private insurance · source - Free medicine program
Quick Start Voucher for a free 1-month supply for eligible new patients.
For: private insurance · source - Bridge or quick-start supply
Bridge Program with up to 4 months of Xyrem free for eligible patients during a coverage delay or interruption.
For: private insurance · source - Free medicine program
The JazzCares Patient Assistance Program provides Jazz medicines at no cost to people who are uninsured or whose insurance does not cover the drug, subject to financial and residency criteria.
For: no insurance, underinsured · source - Insurance and case manager help
JazzCares offers a Nurse Case Manager and a pharmacist available 24/7. Phone 1-833-533-JAZZ (5299), Monday to Friday, 8 AM to 8 PM ET.
For: private insurance, Medicare, Medicaid, no insurance · source
Good to know: Jazz does not publish the dollar amount of the copay maximums. Authorized generic sodium oxybate launched in 2023, and other generics are FDA approved.
Charity funds for Narcolepsy Type 1
- From a charity · NORD RareCareNarcolepsy Medical Assistance fundOpen
Pays for: Medical and medication costs.
The foundation says: “Accepting Applications” - From a charity · NORD RareCareNarcolepsy Premium Copay Assistance fundOpen
Pays for: Insurance premiums and copays.
The foundation says: “Accepting Applications” - From a charity · TotalAssist (formerly PAN Foundation)Narcolepsy fundOpen
Pays for: Out-of-pocket costs for approved medications, up to $5,000 per year. Requires health insurance (any kind).
- From a charity · The Assistance FundNarcolepsy fundWaitlist
Pays for: Copays, coinsurance, deductibles and other health-related expenses.
Access and eligibility
Approved for cataplexy or excessive daytime sleepiness in people 7 years and older with narcolepsy. Not for use with alcohol or sedative sleep medicines, or in succinic semialdehyde dehydrogenase deficiency, a rare inherited condition. Prescribers and the dispensing pharmacy must be certified in the XYWAV and XYREM REMS, and patients must be enrolled. Schedule III controlled substance.
Source: JazzCares for Xyrem (Jazz Pharmaceuticals)
Access program details are provided for informational purposes and may vary based on insurance coverage, geographic location, and individual circumstances. Confirm current eligibility directly with the manufacturer or your specialty pharmacy.
Clinical trial results
The label rests on 4 adult trials and 1 in children. In a 4-week trial of 136 adults, weekly cataplexy attacks fell by a median of 16 on 9g and 10 on 6g against 4 on placebo. In a trial of 55 adults already on Xyrem, attacks rose by a median of 21 over 2 weeks when switched to placebo against 0 on Xyrem. In an 8-week trial of 228 adults, scores on the Epworth Sleepiness Scale, a 0 to 24 questionnaire where lower means less sleepy, fell by a median of 5.0 on 9g and 2.0 on 6g against 0.5 on placebo.
Most adults in the cataplexy trials were also taking stimulants. In children 7 to 17 (NCT02221869, 106 enrolled), those switched to placebo had a median rise of 12.7 weekly cataplexy attacks against 0.3 on Xyrem[1][3]. The trials compared Xyrem with placebo, not with other narcolepsy medicines.
Development history
The FDA approved Xyrem on July 17, 2002 for cataplexy in narcolepsy, approved a supplement on November 18, 2005 that the label history ties to excessive daytime sleepiness, and approved its use in children 7 and older on October 26, 2018, according to Drugs@FDA[2]. Hikma launched an authorized generic of Xyrem in January 2023 and Amneal launched another in July 2023, sold under Jazz's own application, according to their releases[4][5].
Drugs@FDA also lists generic sodium oxybate solutions from Amneal (approved September 2025) and Ascent (November 2025), and an earlier Hikma generic approved in January 2017 that is now discontinued[2]. Whether any generic or authorized generic is on sale today was not confirmed from a primary source as of November 10, 2026. Jazz later developed Xywav, a lower-sodium oxybate mix, and Lumryz from another company is a once-nightly sodium oxybate.
Explore Narcolepsy Type 1 trials
Other Narcolepsy Type 1 treatments
Narcolepsy type 1 has been treated with wake-promoting drugs such as modafinil and armodafinil, stimulants, oxybate medicines taken at night (Xyrem, Xywav and Lumryz), and pitolisant. Orzeyful, approved August 5, 2026, adds a treatment that acts on orexin receptors.
Common questions about Sodium oxybate
▸What is Sodium oxybate (Xyrem)?
A liquid medicine taken in 2 doses each night, at bedtime and 2.5 to 4 hours later, for cataplexy or excessive daytime sleepiness in people 7 years and older with narcolepsy. The FDA approved it for cataplexy in adults in 2002, and it later added daytime sleepiness and, in October 2018, children 7 and older. It carries a boxed warning for slowed breathing and dulled alertness and for abuse and misuse, is a Schedule III controlled substance, and is shipped only through a restricted program from 1 certified central pharmacy.
▸How does Sodium oxybate work?
Narcolepsy type 1 is caused by the loss of brain cells that make orexin (also called hypocretin), a chemical messenger that keeps people awake and stabilizes muscle tone, which leads to daytime sleepiness, cataplexy (sudden muscle weakness set off by strong emotions) and broken nighttime sleep. Sodium oxybate is the sodium salt of gamma-hydroxybutyrate (GHB), a substance that acts on GABA-B receptors, which calm nerve activity. The label says it is thought to work through those receptors, but how it improves narcolepsy symptoms is unknown[1].
▸What are the side effects of Sodium oxybate?
Xyrem has a boxed warning. It slows the brain and breathing, and in trials at recommended doses some adults had dulled alertness and slowed breathing. It is the sodium salt of GHB, and illegal GHB abuse has been linked to seizures, slowed breathing, coma and death, so Xyrem is available only through the XYWAV and XYREM REMS program. The label says it must not be combined with alcohol or sedative sleep medicines, and other drugs that slow the brain, such as opioids and benzodiazepines, raise the risk of dangerous breathing problems. The label also says people should not drive or do hazardous work for at least 6 hours after a dose. In adult trials, side effects seen in at least 5% of people and at least twice as often as on placebo were nausea (up to 20% at 9g against 3%), dizziness (up to 15% against 4%), vomiting (up to 11% against 1%), sleepiness, bedwetting (up to 7% against 1%) and tremor. Side effects led 10.3% of adults to stop, against 2.8% on placebo. In children the most common were nausea (20%), bedwetting (19%), vomiting (18%) and headache (17%). Other warnings cover depression and suicidal thoughts, confusion and anxiety, sleepwalking and high sodium, about 1640mg a night at 9g[1].
▸How is Sodium oxybate taken?
Both nightly doses are prepared before bed, each mixed with about 1/4 cup (60mL) of water. The first is taken in bed at least 2 hours after eating, and the second 2.5 to 4 hours later; people lie down right away and often fall asleep within 5 minutes. Adults start at 4.5g a night split into 2 doses and go up by 1.5g a night each week to 6g to 9g a night; doses above 9g have not been studied. Children 7 and older are dosed by weight, from 20kg up, with a lower starting dose and a lower maximum for lighter children; the label has no dose for children under 20kg. People with liver impairment start at half the usual dose, and the dose is lowered by at least 20% when divalproex is started. A missed second dose is skipped, and the 2 doses are never taken together[1].
▸Is Sodium oxybate FDA approved?
Yes, Sodium oxybate (Xyrem) is FDA approved (2002) for the treatment of Narcolepsy Type 1.
▸How do you take Xyrem?
Xyrem is taken in 2 doses each night, the first in bed at least 2 hours after eating and the second 2.5 to 4 hours later.
Preparing: both doses are mixed with about 1/4 cup of water before bed.
Adult dose: 4.5g a night to start, up to 6g to 9g a night.
Source: Xyrem label on DailyMed, revised July 2025
▸Why is Xyrem only available through one pharmacy?
Because of its boxed warning for slowed breathing and for abuse and misuse, Xyrem is available only through the XYWAV and XYREM REMS program.
How it works: prescribers are certified, 1 certified central pharmacy ships it, and patients are enrolled.
REMS phone: 1-866-997-3688.
Source: Xyrem label on DailyMed, revised July 2025
▸Is there a generic Xyrem?
Generic sodium oxybate exists, but whether any version is on sale today was not confirmed as of November 10, 2026.
Launches: Hikma launched an authorized generic in January 2023 and Amneal in July 2023, according to their releases.
Approvals: Drugs@FDA lists generic solutions from Amneal (September 2025) and Ascent (November 2025).
Source: Drugs@FDA; Hikma and Amneal releases
▸What are the side effects of Xyrem?
In adult trials the most common were nausea, dizziness, vomiting, sleepiness, bedwetting and tremor, and more often at higher doses.
Children: nausea 20%, bedwetting 19%, vomiting 18%, headache 17%.
Serious risks: slowed breathing, especially with alcohol, opioids or other sedating drugs.
Source: Xyrem label on DailyMed, revised July 2025
▸How much sodium is in Xyrem?
About 1100mg of sodium a night at 6g and 1640mg a night at 9g.
Who should ask: people with heart failure, high blood pressure or kidney problems.
Source: Xyrem label on DailyMed, revised July 2025
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- U.S. National Library of Medicine · 2025-07. DailyMed - XYREM- sodium oxybate solution. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=926eb076-a4a8-45e4-91ef-411f0aa4f3ca
- U.S. Food and Drug Administration. Drugs@FDA: XYREM (NDA 021196) approval history. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021196
- ClinicalTrials.gov. A Multicenter Study of the Efficacy and Safety of Xyrem With an Open-Label Pharmacokinetic Evaluation and Safety Extension in Pediatric Subjects With Narcolepsy With Cataplexy. https://clinicaltrials.gov/study/NCT02221869
- Hikma Pharmaceuticals · 2023-01-03. Hikma launches authorized generic of Xyrem® (sodium oxybate) in the US. https://www.hikma.com/news/hikma-launches-authorized-generic-of-xyrem-sodium-oxybate-in-the-us/
- Amneal Pharmaceuticals via Business Wire · 2023-07-03. Amneal Launches Authorized Generic for Xyrem (Sodium Oxybate) and Receives FDA Approval for Five Complex Generics in the Second Quarter. https://www.biospace.com/amneal-launches-authorized-generic-for-xyrem-sodium-oxybate-and-receives-fda-approval-for-five-complex-generics-in-the-second-quarter
- Jazz Pharmaceuticals. JazzCares | Xyrem Patients. https://www.jazzcares.com/patients/xyrem