Transcept's Roller Coaster Year Ends with Intermezzo Approval

Back in July, it looked like Transcept Pharmaceutical Inc.'s insomnia drug Intermezzo (zolpidem tartrate) was down for the count. The company, aiming to provide the first treatment specifically for middle-of-the-night waking, had just gotten a surprise second complete response letter (CRL), despite conducting the FDA-requested next-day highway driving study.