XYREM® (sodium oxybate) oral solution, 0.5 g/mL is a prescription medicine used to treat the following symptoms in people 7 years of age or older with narcolepsy:
- sudden onset of weak or paralyzed muscles (cataplexy);
- excessive daytime sleepiness (EDS).
It is used sometimes in France and Italy as an anesthetic given intravenously; it is also used in Italy to treat alcohol addiction and alcohol withdrawal syndrome.
Sodium oxybate is the sodium salt of γ-hydroxybutyric acid (GHB). 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 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 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. In Canada and the European Union it was classified as a Schedule III and a Schedule IV controlled substance, respectively.
It was approved for treating symptoms of narcolepsy in the European Union in 2005.
Orphan Medical had developed it and was acquired by Jazz Pharmaceuticals in 2005. The drug is marketed in Europe by UCB. 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.