Searle’s Ambien (zolpidem)

Executive Summary

HHS recommends that the nonbenzodiazepine hypnotic be categorized as a Schedule IV controlled substance in a Sept. 15 request to the Drug Enforcement Administration, a Nov. 24 Federal Register notice states. DEA will accept comments until Dec. 24. Deemed "approvable" by FDA on April 21, Ambien has been pending approval since January 1989 as a treatment for short-term and chronic insomnia. Labeling discussions are ongoing with FDA, Searle reported Nov. 24. By a close vote, FDA's Drug Abuse Advisory Committee had recommended in February that the drug be classified as Schedule V ("The Pink Sheet" March 2, T&G-5). Benzodiazepine hypnotics are classified as Schedule IV. Ambien was developed by Lorex Pharmaceuticals, a joint Searle venture with the French firm Synthelabo. Searle bought out Lorex this year.