![]() ![]() 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.īecause 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. Abuse and MisuseThe active moiety of XYWAV is oxybate or gamma-hydroxybutyrate (GHB).Many patients who received XYWAV during clinical trials in narcolepsy and idiopathic hypersomnia were receiving CNS stimulants. Clinically significant respiratory depression and obtundation may occur in patients treated with XYWAV at recommended doses. Central Nervous System DepressionXYWAV is a CNS depressant. ![]() WARNING: CENTRAL NERVOUS SYSTEM DEPRESSION and ABUSE AND MISUSE. Prevalence of excess sodium intake in the United States-NHANES, 2009-2012. Jackson SL, King SM, Zhao L, Cogswell ME.US Department of Health and Human Services, US Food and Drug Administration website.Palo Alto, CA: Jazz Pharmaceuticals, Inc. Recently approved and upcoming treatments for narcolepsy. Efficacy and safety of calcium, magnesium, potassium, and sodium oxybates (lower-sodium oxybate JZP-258) in a placebo-controlled, double-blind, randomized withdrawal study in adults with narcolepsy with cataplexy. Bogan RK, Thorpy MJ, Dauvilliers Y, et al.XYWAV ® (calcium, magnesium, potassium, and sodium oxybates).Narcolepsy is complicated by high medical and psychiatric comorbidities: a comparison with the general population. ![]()
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