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Clinical Superiority Based on Greater Safety Due to Sodium Reduction1
According to the US Food and Drug Administration (FDA), XYWAV is clinically superior to XYREM® (sodium oxybate) oral solution due to greater cardiovascular (CV) safety because the reduction in sodium at recommended doses will help a substantial portion of indicated patients reduce the risk of developing CV disease.1,a
Low-sodium XYWAV is indicated for the treatment of cataplexy and/or EDS in patients 7 years of age or older with narcolepsy.b
See how XYWAV received clinical superiority over XYREM due to reduced sodium burden.1,2
XYWAV oral solution, 0.5 g/mL total salts (equivalent to 0.413 g/mL of oxybate) is indicated for the treatment of cataplexy and/or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.
aBased on the determination of orphan drug exclusivity by the FDA Office of Orphan Products Development (OOPD) between XYREM and XYWAV. There are no head-to-head data for XYWAV and XYREM.
bXYWAV contains 131 mg of sodium at the maximum recommended nightly dose.
References: 1. US Food and Drug Administration. Clinical superiority findings. https://www.fda.gov/industry/designating-orphan-product-drugs-and-biological-products/clinical-superiority-findings. Accessed July 1, 2024. 2. Chen C et al. Clin Transl Sci. 2021;14(6):2278-2287.
Comorbidity Data
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Sodium and CV Risk
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Sodium Difference
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Clinical Superiority
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Patient and HCP Voices
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Important Safety Information
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 were receiving CNS stimulants.