Transcept Pharmaceuticals announced that the FDA has approved Intermezzo (zolpidem tartrate sublingual tablets) for the treatment of insomnia characterized by middle-of-the-night waking followed by difficulty returning to sleep. This approval was based on data from two clinical trials involving more than 370 patients. In the studies, patients taking Intermezzo had a shorter time to fall back asleep after waking compared with patients taking a placebo.
Intermezzo is a Schedule C-IV substance.
For more information call (510) 215-3500 or visit www.transcept.com.