FDA label
What is sodium oxybate used for?
The FDA-approved uses of sodium oxybate, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “Sodium oxybate oral solution is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients with narcolepsy.”
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Sodium Oxybate, solution
Indications and Usage, quoted from the label by Camber Pharmaceuticals, Inc. (ANDA210523). Cross-references to other label sections are left out.
Sodium oxybate oral solution is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients with narcolepsy.
Pediatric use information is approved for Jazz Pharmaceuticals Inc.’s XYREM (sodium oxybate) Oral Solution. However, due to Jazz Pharmaceuticals Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Source: DailyMed label, set id 5dcf9a5c-312b-420b-82f3-42177d8f9ee4, version 3, effective April 21, 2026. NDC 31722-891, one of 3 listings for this product.
Questions
What is sodium oxybate used for?
The FDA label says: “Sodium oxybate oral solution is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients with narcolepsy.”
What drug class is sodium oxybate?
FDA lists sodium oxybate in the Central Nervous System Depressant established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
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