Sodium oxybate was approved for use by the 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 CNS depressants, such as alcohol and its use may cause dependence. In Canada and the European Union (EU) it was classified as a Schedule III and a Schedule IV controlled substance, respectively.