FDA approves Xyrem for the treatment of cataplexy and excessive daytime sleepiness in pediatric patients with narcolepsy.- Jazz Pharma

The FDA approved Xyrem (sodium oxybate) for the treatment of cataplexy and excessive daytime sleepiness (EDS) in pediatric patients (7 to 17 years old) with narcolepsy. Xyrem is a central nervous system depressant that was approved in 2002 for the treatment of cataplexy in adult patients with narcolepsy. Cataplexy is a sudden and transient episode of muscle weakness accompanied by full conscious awareness, typically triggered by emotions such as laughing, crying, or terror.

Xyrem either alone or in combination with other central nervous system depressants may be associated with adverse reactions including seizure, respiratory depression, decreases in the level of consciousness, coma, and death. The rapid onset of sedation, coupled with amnesia, particularly when combined with alcohol, has posed risks for voluntary and involuntary users (eg, assault victims). Xyrem is contraindicated in patients being treated with sedative hypnotic agents and in patients with succinic semialdehyde dehydrogenase deficiency. In addition, patients should not drink alcohol when using Xyrem. Succinic semialdehyde deficiency is a rare inborn error of metabolism variably characterized by mental retardation, hypotonia, and ataxia.