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# Jazz Pharma Hypersomnia Drug Approved
- URL: https://www.fdaweb.com/jazz-pharma-hypersomnia-drug-approved/
- Published: 2021-08-12T12:00:00.000Z
- Updated: 2026-09-14T17:10:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149928

FDA has approved a Jazz Pharmaceuticals NDA for Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for treating idiopathic hypersomnia in adults. Idiopathic hypersomnia is a debilitating neurologic sleep disorder characterized by chronic excessive daytime sleepiness. In addition to excessive daytime sleepiness, symptoms may include severe sleep inertia or sleep drunkenness, as well as prolonged, non-restorative nighttime sleep, cognitive impairment, and long and unrefreshing naps.  

Approval was based on data from a Phase 3 double-blind, placebo-controlled, randomized withdrawal study that demonstrated statistically significant and clinically meaningful differences compared to placebo in change in the primary endpoint of Epworth Sleepiness Scale score and secondary endpoints of Patient Global Impression of Change and the Idiopathic Hypersomnia Severity Scale, according to the company.  

During the study, the most common adverse reactions in adults were nausea, headache, dizziness, anxiety, insomnia, decreased appetite, hyperhidrosis, vomiting, diarrhea, dry mouth, parasomnia, somnolence, fatigue and tremor, Jazz says.