Special Web Page Has Information on New Narcolepsy Drug

Special Web Page Has Information on New Narcolepsy Drug

FDA's Center for Drug Evaluation and Research has created a Web page with background on Xyrem, a drug approved July 17 to treat cataplexy (weak or
paralyzed muscles) in patients with narcolepsy, a condition that causes an irresistable urge to fall asleep in unlikely situations. The page answers many questions about the drug such as how it will be distributed and what to do with unused medication.

Xyrem (sodium oxybate)

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The Food and Drug Administration approved Xyrem (sodium oxybate or gamma hydroxybutyrate, also known as GHB) for treating a small population of patients with narcolepsy who experience episodes of cataplexy, a condition characterized by weak or paralyzed muscles. Because of safety concerns associated with the use of the drug, the distribution of Xyrem will be tightly restricted.

• FDA Talk Paper on Xyrem


• Medication Guide for Xyrem


• Questions and Answers About Xyrem

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