FDA label
What is Xywav used for?
Xywav contains sodium oxybate, calcium oxybate, potassium oxybate and magnesium oxybate. The FDA-approved uses below are 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 for Xywav lists 2 uses: Narcolepsy; Idiopathic Hypersomnia.
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Xywav, solution
Indications and Usage, quoted from the label by Jazz Pharmaceuticals, Inc. (NDA212690). Cross-references to other label sections are left out.
Narcolepsy
XYWAV is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.
Idiopathic Hypersomnia
XYWAV is indicated for the treatment of idiopathic hypersomnia (IH) in adults.
Source: DailyMed label, set id 1e0ae43a-037f-42af-8e23-a0e51d75abe8, version 16, effective July 1, 2025. NDC 68727-150, one of 1 listing for this product.
Questions
What is Xywav used for?
The FDA label for Xywav lists 2 uses: Narcolepsy; Idiopathic Hypersomnia.
What drug class is Xywav?
FDA lists sodium oxybate, calcium oxybate, potassium oxybate and magnesium 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.
More on Xywav
- Is Xywav a controlled substance?Schedule III
- Generic for XywavFDA Orange Book
- Is Sodium Oxybate, Calcium Oxybate, Potassium Oxybate and Magnesium Oxybate a controlled substance?Schedule III
- Central Nervous System Depressants listFDA drug class
- Xywav Medicare Part D coverageBy plan and state
- NDC 68727-150Xywav NDC record
- Schedule III drugs listDEA schedule