Please see Important Safety Information in the pinned post or at https://www.XywavHCP.com/#isi, and see full Prescribing Information, including BOXED Warning, at https://pp.jazzpharma.com/pi/xywav.en.USPI.pdf.
XYWAV is indicated for the treatment of cataplexy and/or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy, and for the treatment of idiopathic hypersomnia (IH) in adults.
WARNING: CENTRAL NERVOUS SYSTEM DEPRESSION AND ABUSE AND MISUSE.
Central Nervous System Depression
XYWAV is a CNS depressant. Clinically significant respiratory depression and obtundation may occur in patients treated with XYWAV at recommended doses. Many patients who received XYWAV during clinical trials in narcolepsy and idiopathic hypersomnia were receiving CNS stimulants.
Abuse and Misuse
The active moiety of XYWAV is oxybate or gamma-hydroxybutyrate (GHB). Abuse or misuse of illicit GHB, either alone or in combination with other CNS depressants, is associated with CNS adverse reactions, including seizure, respiratory depression, decreases in the level of consciousness, coma, and death.
Because of the risks of CNS depression and abuse and misuse, XYWAV is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the XYWAV and XYREM REMS.
To learn more about XYWAV, visit www.XywavHCP.com.
From time to time, this page may share links to third-party sites that you may find useful. Jazz Pharmaceuticals does not endorse and is not responsible for the content of these third-party sites.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. For information about adverse events or product complaints related to Jazz Pharmaceuticals’ products, visit www.jazzpharma.com/medicines/drug-safety.
This page is for US healthcare professionals (HCPs) only.
© 2025 Jazz Pharmaceuticals, Inc.
US-XYW-2400255 Rev0225
Company Details
- Industry
- Pharmaceutical Manufacturing
- NAICS
-
Pharmaceutical and Medicine ManufacturingMedicinal and Botanical ManufacturingPharmaceutical Preparation ManufacturingIn-Vitro Diagnostic Substance ManufacturingBiological Product (except Diagnostic) Manufacturing
- Website
- https://www.XywavHCP.com
- Keywords
- Raleigh.
Xywav® (Calcium, Magnesium, Potassium, And Sodium Oxybates) Questions
Xywav® (Calcium, Magnesium, Potassium, And Sodium Oxybates)'s website is https://www.XywavHCP.com
Xywav® (Calcium, Magnesium, Potassium, And Sodium Oxybates)'s LinkedIn profile is https://www.linkedin.com/company/xywavhcp
Xywav® (Calcium, Magnesium, Potassium, And Sodium Oxybates)'s industry is
Pharmaceutical Manufacturing
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Xywav® (Calcium, Magnesium, Potassium, And Sodium Oxybates)'s categories are Pharmaceutical Manufacturing
