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Xywav Approval History

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

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.

  • Xyrem (sodium oxybate) was the first medicine approved for the treatment of cataplexy and EDS in patients with narcolepsy, but it carries a warning about its high sodium content. Xywav provides a low-sodium alternative to Xyrem, with 92 percent less sodium per nightly dose.
  • Xywav has a Boxed Warning as a central nervous system depressant, and for its 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: the first at bedtime at least 2 hours after eating, and the second 2½ to 4 hours later. The two doses can be titrated into equal or unequal amounts, depending on response.
  • Common adverse reactions in adults include headache, nausea, dizziness, decreased appetite, parasomnia, diarrhea, hyperhidrosis, anxiety and vomiting. Common adverse reactions in children include bedwetting, nausea, headache, vomiting, weight decrease, decreased appetite, and dizziness.

Development History and FDA Approval Process for Xywav

DateArticle
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.