Prescription medicine
Calcium oxybate, magnesium oxybate, potassium oxybate and sodium oxybate Brand names: Xywav
Calcium oxybate, magnesium oxybate, potassium oxybate and sodium oxybate (Xywav) is a prescription medicine with an FDA approval on record since 2020. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
- DEA Schedule III
Check it at the source: the calcium oxybate, magnesium oxybate, potassium oxybate and sodium oxybate FDA label on DailyMed (effective July 1, 2025, Jazz Pharmaceuticals, Inc.); the NDA 212690 record on Drugs@FDA; every calcium oxybate, magnesium oxybate, potassium oxybate and 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 XYWAV is a CNS depressant. Clinically significant respiratory depression and obtundation may occur in patients treated with XYWAV at recommended doses [see Warnings and Precautions ( 5.1 , 5.4 )]. Many patients who received XYWAV during clinical trials in narcolepsy and idiopathic hypersomnia were receiving central nervous system stimulants [see Clinical Studies ( 14.1 , 14.2 , 14.3 )].
Abuse and Misuse The active moiety of XYWAV is oxybate or 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, XYWAV 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 usageXYWAV 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 ( 1.1 ).
Forms and strengths
- 0.5 g/ml / 0.5 g/ml / 0.5 g/ml / 0.5 g/ml
Solution.
On the market
- Earliest approval on file
- July 21, 2020 Xywav, Jazz; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- February 22, 2041 Xywav oral solution; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 8,562 through July 30, 2026
What is calcium oxybate, magnesium oxybate, potassium oxybate and sodium oxybate used for?
From the label: indications and usageXYWAV 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 ( 1.1 ).
Idiopathic Hypersomnia (IH) in adults ( 1.2 ). 1.1 Narcolepsy XYWAV is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. 1.2 Idiopathic Hypersomnia XYWAV is indicated for the treatment of idiopathic hypersomnia (IH) in adults.
FDA pharmacologic class: Central Nervous System Depressant.
Source: FDA drug label (XYWAV), Jazz Pharmaceuticals, Inc., effective July 1, 2025 (SPL set 1e0ae43a-037f-42af-8e23-a0e51d75abe8), via openFDA; the full label on DailyMed
What does the patient leaflet for calcium oxybate, magnesium oxybate, potassium oxybate and 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 XYWAV?XYWAV is a central nervous system (CNS) depressant. Taking XYWAV 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. • XYWAV is a federal controlled substance (CIII). The active ingredient of XYWAV 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 XYWAV 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 XYWAV. Those activities should not be done until you know how XYWAV affects you or your child. • Keep XYWAV in a safe place to prevent abuse and misuse. Selling or giving away XYWAV 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 XYWAV?Store XYWAV in the original bottle prior to mixing with water. After mixing with water, store XYWAV in the pharmacy containers with child-resistant caps provided by the pharmacy. • Store XYWAV at room temperature between 68°F to 77°F (20°C to 25°C). • XYWAV solution prepared after mixing with water should be taken within 24 hours. • When you have finished using a XYWAV bottle: o empty any unused XYWAV down the sink drain. o cross out the label on the XYWAV bottle with a marker. o place the empty XYWAV bottle in the trash. XYWAV comes in a child-resistant package. Keep XYWAV and all medicines out of the reach of children and pets.
Source: FDA drug label (XYWAV), Jazz Pharmaceuticals, Inc., effective July 1, 2025 (SPL set 1e0ae43a-037f-42af-8e23-a0e51d75abe8), via openFDA; the full label on DailyMed
Is there a generic for calcium oxybate, magnesium oxybate, potassium oxybate and sodium oxybate (Xywav)?
No generic calcium oxybate, magnesium oxybate, potassium oxybate and sodium oxybate is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 16 patents for Xywav oral solution, the last expiring on February 22, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2020 earliest approval on file
- 2041 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the calcium oxybate, magnesium oxybate, potassium oxybate and sodium oxybate label say about other medicines?
The calcium oxybate, magnesium oxybate, potassium oxybate and 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 XYWAV dose of at least 20% is recommended ( 2.7 , 7.2 ). |
| Valproic acid | drug interactions | Concomitant use with divalproex sodium: An initial reduction in XYWAV dose of at least 20% is recommended ( 2.7 , 7.2 ). |
Source: FDA drug label (XYWAV), Jazz Pharmaceuticals, Inc., effective July 1, 2025 (SPL set 1e0ae43a-037f-42af-8e23-a0e51d75abe8), via openFDA; the full label on DailyMed
What do FAERS reports show for calcium oxybate, magnesium oxybate, potassium oxybate and sodium oxybate?
The FDA Adverse Event Reporting System holds 8,562 reports that list calcium oxybate, magnesium oxybate, potassium oxybate and sodium oxybate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 81 are coded as a death and 1,601 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 2024 (2,063, against a median of 11 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
- Calcium oxybate, magnesium oxybate, potassium oxybate and sodium oxybate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other