Skip to main content

Xywav FDA Approval History

Last updated by Judith Stewart, BPharm on Aug 16, 2021.

FDA Approved: Yes (First approved July 21, 2020)
Brand name: Xywav
Generic name: calcium, magnesium, potassium, and sodium oxybates
Dosage form: Oral Solution
Company: Jazz Pharmaceuticals plc
Treatment for: Narcolepsy; Idiopathic Hypersomnia

Xywav (calcium, magnesium, potassium, and sodium oxybates) is a low-sodium oxybate product for the treatment of cataplexy and excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy, and for the treatment of idiopathic hypersomnia (IH) in adults.

  • Xywav provides a low-sodium alternative to Xyrem (sodium oxybate) with 92 percent less sodium per nightly dose.
  • Xywav is a central nervous system (CNS) depressant. It contains a mixture of calcium oxybate, magnesium oxybate, potassium oxybate, and sodium oxybate (gamma-hydroxybutyrate). Sodium oxybate is thought to interact with GABAreceptors to improve sleep efficiency.
  • The Xywav product label carries a Boxed Warning for CNS depression, and potential for abuse and misuse. Xywav is available only through a restricted program under a REMS called the Xywav and Xyrem REMS Program. Xywav is listed as a Schedule III medicine under the Controlled Substances Act.
  • Xywav is an oral solution that is administered at night in two doses for the treatment of narcolepsy, and one or two doses at night for the treatment of idiopathic hypersomnia. The first dose is taken at bedtime at least 2 hours after eating, and the second dose is taken 2½ to 4 hours later. The doses can be titrated depending on response.
  • Common adverse reactions in adults include nausea, headache, dizziness, anxiety, insomnia, decreased appetite, hyperhidrosis, vomiting, diarrhea, dry mouth, parasomnia, somnolence, fatigue, and tremor. Common adverse reactions in children include nausea, enuresis, vomiting, headache, weight decreased, decreased appetite, dizziness, and sleepwalking.

 

Development Timeline for Xywav

DateArticle
Aug 12, 2021Approval  Jazz Pharmaceuticals Announces U.S. FDA Approval of Xywav (calcium, magnesium, potassium, and sodium oxybates) Oral Solution for Idiopathic Hypersomnia in Adults
Jul 22, 2020Approval  FDA Approves Xywav (calcium, magnesium, potassium, and sodium oxybates) Oral Solution for Cataplexy or Excessive Daytime Sleepiness Associated with Narcolepsy
Jan 22, 2020Jazz Pharmaceuticals Submits New Drug Application for JZP-258 for Cataplexy and Excessive Daytime Sleepiness Associated with Narcolepsy
Dec  3, 2018Jazz Pharmaceuticals Announces First Patient Enrolled in Phase 3 Clinical Trial Evaluating JZP-258 for the Treatment of Idiopathic Hypersomnia

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.