Safety Overview of Postmarketing and Clinical Experience of Sodium Oxybate (Xyrem): Abuse Misuse Dependence and Diversion

摘要

Study Objectives:This study reviewed the cumulative postmarketing and clinical safety experience with sodium oxybate (Xyrem®), a treatment approved for cataplexy and excessive daytime sleepiness in narcolepsy. Study objectives were to investigate the occurrence of abuse/misuse of sodium oxybate since first market introduction in 2002, classify cases using DSM-IV criteria for substance abuse and dependence, and describe specific characteristics of these cases.