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Sodium oxybate (USAN) (brand names Xyrem, Alcover, Anetamin, Gamanest, Gioron, Somsanit), contracted from sodium γ-hydroxybutyrate, is a prescription medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of excessive daytime sleepiness (EDS) associated with narcolepsy, and by the FDA and Health Canada for the treatment of cataplexy associated with narcolepsy. Sodium oxybate is the sodium salt of γ-hydroxybutyric acid (GHB). Xyrem is manufactured by Jazz Pharmaceuticals in the US and Valeant Pharmaceuticals in Canada. Under the name Alcover, it is used in Italy for treatment of alcohol withdrawal and dependence. ==Side effects== The American Academy of Sleep Medicine (AASM) recommends sodium oxybate as a standard of care for the treatment of cataplexy, daytime sleepiness, and disrupted sleep due to narcolepsy in its Practice Parameters for the Treatment of Narcolepsy and other Hypersomnias of Central Origin, and the drug has been safely used by patients with narcolepsy since 2002.〔 A recent analysis evaluated the postmarketing safety of sodium oxybate, including rates of abuse, dependence, and withdrawal, using a conservative application of the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria to all worldwide sodium oxybate adverse event cases containing reporting terminology related to abuse or misuse.〔 The analysis included cases reported to the manufacture from market introduction in 2002 through March 2008. Using the DSM-IV criteria, the analysis found the following rates of abuse, dependence, and withdrawal of the approximately 26,000 patients who used sodium oxybate during this period: * Abuse – 10 cases (0.04%) * Dependence – 4 cases (0.016%) * Withdrawal symptoms after discontinuation – 8 cases (0.031%; including 3 of the previous 4 dependence cases) The analysis also found 2 confirmed cases (0.008%) of sodium oxybate–facilitated sexual assault; in both cases the women knew that they were taking sodium oxybate. In addition, there were 21 deaths (0.08%) in patients receiving sodium oxybate treatment, with 1 death known to be related to sodium oxybate, and 3 cases (0.01%) of traffic accidents involving drivers taking sodium oxybate. The extremely low rates of abuse, dependence, withdrawal, and assault found in this analysis suggest that after seven years of commercial availability, sodium oxybate use is largely appropriate and confined to patients with legitimate therapeutic needs.〔 In the US, sodium oxybate is classified as a Schedule III controlled substance for medicinal use under the Controlled Substances Act, with illicit use subject to Schedule I penalties. Examples of other schedule III products in the US include Tylenol with codeine, and testosterone.〔(【引用サイトリンク】title=Drug Scheduling )〕 In Canada and the European Union (EU), it is classified as a Schedule III and a Schedule IV controlled substance, respectively.〔 Sodium oxybate is the only treatment for narcolepsy approved by the World Anti-Doping Agency, and has been instrumental in allowing cyclist Franck Bouyer to resume his career.〔Bouygues (25 Jan. 2009) (Bouyer: "Une nouvelle expérience" ) (''in French''.) Retrieved 5 March 2010.〕 On October 18, 2011, Jazz Pharmaceuticals, Inc. disclosed that it had received a Warning Letter from the FDA for specific violations during the FDA's inspection of the firm from April 27, 2011 through May 6, 2011. In the letter the FDA cited 2 specific violations: 1. Failure to develop adequate written procedures for the surveillance, receipt, evaluation, and reporting of postmarketing adverse drug experiences to FDA (C.F.R § 314.80(b) ). 2. Failure to submit adverse drug experience (ADE) reports that are both serious and unexpected to FDA within 15 calendar days of initial receipt of the information by the applicant (C.F.R. § 314.80(c)(1)(i) ). The firm also received an FDA form 483 on September 27, 2007, for similar post-marketing safety violations.〔 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「Sodium oxybate」の詳細全文を読む スポンサード リンク
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