![]() Reviews of sodium oxybate concluded that it is well tolerated and associated with "significant reductions in cataplexy and daytime sleepiness," and that its effectiveness "in treating major, clinically relevant narcolepsy symptoms and sleep architecture abnormalities" has been established. The major use of sodium oxybate is in treating two of the symptoms of narcolepsy – cataplexy (sudden muscle weakness) and excessive daytime sleepiness. Medical use Ĭlinical use of sodium oxybate was introduced in Europe in 1964, as anesthetic given intravenously but it was not widely used since it sometimes caused seizures as of 2006, it was still authorized for this use in France and Italy but not widely used. Jazz raised the price of the drug dramatically after it acquired Orphan, and paid a $20M fine for off-label marketing of the drug in 2007. Orphan Medical had developed it and was acquired by Jazz Pharmaceuticals in 2005. It was approved for treating symptoms of narcolepsy in the European Union in 2005. In Canada and the European Union it was classified as a Schedule III and a Schedule IV controlled substance, respectively. The US label for sodium oxybate also has a black box warning because it is a central nervous system depressant and may cause respiratory depression, seizures, coma, or death, especially if used in combination with other central nervous system depressants, such as alcohol and its use may cause dependence. Sodium oxybate was approved for use by the US Food and Drug Administration (FDA) to treat symptoms of narcolepsy in 2002, with a strict risk evaluation and mitigation strategy (REMS) program mandated by the FDA. The clinical trials for narcolepsy were conducted just as abuse of GHB as a club drug and date rape drug became a matter of public concern in 2000 GHB was made a Schedule I controlled substance, while sodium oxybate, when used under an FDA NDA or IND application, was classified as a Schedule III controlled substance for medicinal use under the Controlled Substances Act, with illicit use subject to Schedule I penalties. ![]() Sodium oxybate is the sodium salt of γ-hydroxybutyric acid (GHB). It is used sometimes in France and Italy as an anesthetic given intravenously : 15, 27–28 it is also used in Italy to treat alcohol addiction and alcohol withdrawal syndrome. Sodium oxybate, sold under the brand name Xyrem among others, is a medication used to treat two symptoms of narcolepsy: sudden muscle weakness and excessive daytime sleepiness.
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