Prescription medicine
Sodium oxybate Brand names: Lumryz, Xyrem
Sodium oxybate (Xyrem) is a prescription medicine with an FDA approval on record since 2002. FDA's NDC Directory lists it from 3 generic labelers.
- Generic listed
- A presentation discontinued
- Boxed warning
- DEA Schedule III
Check it at the source: the sodium oxybate FDA label on DailyMed (effective July 1, 2025, Jazz Pharmaceuticals, Inc.); the NDA 21196 record on Drugs@FDA; every sodium oxybate label on DailyMed.
Highlights of the record
FDA label of July 1, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
CENTRAL NERVOUS SYSTEM.
DEPRESSION and ABUSE AND MISUSE.
Central Nervous System Depression Xyrem (sodium oxybate) is a CNS depressant. In clinical trials at recommended doses, obtundation and clinically significant respiratory depression occurred in adult patients treated with Xyrem [see Warnings and Precautions ( 5.1 )]. Many patients who received Xyrem during clinical trials in narcolepsy were receiving central nervous system stimulants [see Clinical Trials ( 14 )].
Abuse and Misuse Xyrem ® (sodium oxybate) is the sodium salt of gamma-hydroxybutyrate (GHB). Abuse or misuse of illicit GHB, either alone or in combination with other CNS depressants, is associated with CNS adverse reactions, including seizure, respiratory depression, decreases in the level of consciousness, coma, and death [see Warnings and Precautions ( 5.2 )]. Because of the risks of CNS depression and abuse and misuse, Xyrem is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the XYWAV and XYREM REMS [see Warnings and Precautions ( 5.3 )]. WARNING: CENTRAL NERVOUS SYSTEM (CNS) DEPRESSION and ABUSE AND MISUSE. See full prescribing information for complete boxed warning. […]
Used for
From the label: indications and usageXyrem is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.
Forms and strengths
- 4.5 g
- 6 g
- 7.5 g
- 9 g
- 0.5 g/ml
- 500 mg/ml
Solution; extended-release for suspension; kit.
On the market
- Earliest approval on file
- July 17, 2002 Xyrem, Jazz Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 3 first January 17, 2017; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 6 of which 3 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- September 15, 2033 Xyrem oral solution; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- None current 1 past records
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 61,996 through July 30, 2026
What is sodium oxybate used for?
From the label: indications and usageXyrem is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. Xyrem is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy ( 1 ).
FDA pharmacologic class: Central Nervous System Depressant.
Source: FDA drug label (Xyrem), Jazz Pharmaceuticals, Inc., effective July 1, 2025 (SPL set 926eb076-a4a8-45e4-91ef-411f0aa4f3ca), via openFDA; the full label on DailyMed
What does the patient leaflet for sodium oxybate say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: 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: o trouble breathing (respiratory depression) o low blood pressure (hypotension) o changes in alertness (drowsiness) o fainting (syncope) o death Ask your doctor if you are not sure if you are, or your child is, taking a medicine 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 federal controlled substance (CI). Abuse of illegal GHB, either alone or with other CNS depressants may cause serious medical problems, including: o seizure o trouble breathing (respiratory depression) o changes in alertness (drowsiness) o coma o death Call your doctor right away if you have 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. […]
From the patient leaflet: How should I store XYREM?Store XYREM in the original bottle prior to mixing 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: o empty any unused XYREM down the sink drain o cross out the label on the XYREM bottle with a marker o 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.
Source: FDA drug label (Xyrem), Jazz Pharmaceuticals, Inc., effective July 1, 2025 (SPL set 926eb076-a4a8-45e4-91ef-411f0aa4f3ca), via openFDA; the full label on DailyMed
Is there a generic for sodium oxybate (Xyrem)?
The FDA approved the first generic sodium oxybate on January 17, 2017. 3 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists sodium oxybate from 3 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 7 patents for Xyrem oral solution, the last expiring on September 15, 2033; a patent listed only for Lumryz for oral suspension runs to March 16, 2042. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2002 earliest approval on file
- 2017 first generic approved
- 2033 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is sodium oxybate in shortage?
No sodium oxybate presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 1 record is all marked to be discontinued, the latest updated December 29, 2025. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Sodium Oxybate, Solution, .5 g/1 mL (NDC 69238-2391-1) | Amneal Pharmaceuticals | To Be Discontinued | December 29, 2025 |
Every sodium oxybate presentation in the FDA shortage database
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
What does the sodium oxybate label say about other medicines?
The sodium oxybate label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Divalproex | drug interactions | Concomitant use with divalproex sodium: An initial reduction in Xyrem dose of at least 20% is recommended ( 2.5 , 7.2 ). |
| Valproic acid | drug interactions | Concomitant use with divalproex sodium: An initial reduction in Xyrem dose of at least 20% is recommended ( 2.5 , 7.2 ). |
Source: FDA drug label (Xyrem), Jazz Pharmaceuticals, Inc., effective July 1, 2025 (SPL set 926eb076-a4a8-45e4-91ef-411f0aa4f3ca), via openFDA; the full label on DailyMed
What do FAERS reports show for sodium oxybate?
The FDA Adverse Event Reporting System holds 61,996 reports that list sodium oxybate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 935 are coded as a death and 7,490 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2016 (19,535, against a median of 2,958 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other central nervous system depressants
- the pharmacologic class, with prices and generics
- Sodium oxybate side effects
- the label's list beside FAERS reports
- Sodium oxybate shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other