FDA label
What is Xyrem used for?
Xyrem contains sodium 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 says: “Xyrem is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.”
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Xyrem, solution
Indications and Usage, quoted from the label by Jazz Pharmaceuticals, Inc. (NDA021196). Cross-references to other label sections are left out.
Xyrem is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.
Source: DailyMed label, set id 926eb076-a4a8-45e4-91ef-411f0aa4f3ca, version 27, effective July 1, 2025. NDC 68727-100, one of 1 listing for this product.
Questions
What is Xyrem used for?
The FDA label says: “Xyrem is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.”
What drug class is Xyrem?
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.
More on Xyrem
- Is Xyrem a controlled substance?Schedule III
- Generic for XyremFDA Orange Book
- What is Sodium Oxybate used for?FDA label uses
- Is Sodium Oxybate a controlled substance?Schedule III
- Generic for LumryzFDA Orange Book
- Central Nervous System Depressants listFDA drug class
- NDC 68727-100Xyrem NDC record
- Schedule III drugs listDEA schedule