Historical note and terminology
Sodium oxybate is a medical formulation of gamma-hydroxybutyrate, which occurs naturally in many human tissues as a metabolite of gamma-amino butyric acid. Gamma-hydroxybutyrate, classified as a Schedule I controlled substance in the United States, was used in the 1970s and 1980s and showed promise for various symptoms of narcolepsy.
Over-the-counter sales of this substance were banned in 1990 because of overdosing by weightlifters and recreational abusers. It got a bad reputation as a "date-rape" drug. Clinical development of gamma-hydroxybutyrate in narcolepsy started in 1996. A bill, passed in the United States Congress in 2000, supported the continued development of medically formulated gamma-hydroxybutyrate, and sodium oxybate is now classified as a Schedule III controlled substance by federal law. Although initially approved by the Food and Drug Administration in 2002, release for marketing was delayed pending further safety trials. In 2005, sodium oxybate was finally cleared by the Food and Drug Administration to treat excessive daytime sleepiness in patients with narcolepsy. It is the first and the only FDA-approved medication for the treatment of cataplexy associated with narcolepsy. Due to the known drug abuse of sodium oxybate, the approval of this drug is contingent on a risk management plan that restricts distribution through a single central pharmacy and requires use of a specific prescription form.
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