Searle's Ambien

Executive Summary

Receives April 21 "approvable" letter. The nonbenzodiazepine hypnotic zolpidem tartrate, which was developed by the Searle/Synthelabo joint venture Lorex, has been pending approval at FDA since January 1989. FDA's Drug Abuse Advisory Committee recently voted by a narrow margin to classify zolpidem as a Schedule V drug ("The Pink Sheet" March 2, T&G-5). Benzodiazepine hypnotics are Schedule IV, a slightly more restrictive category. Ambien will be zolpidem's trade name in North America, where Searle has marketing rights. In Europe, where Synthlabo markets the drug, the brandname is Stilnox.