FDA approves Intermezzo (Transcept Pharmaceuticals) for use with middle-of-the-night Insomnia

The FDA has approved Intermezzo (zolpidem tartrate sublingual tablets), from Transcept Pharmaceuticals, for use as needed to treat insomnia characterized by middle-of-the-night waking followed by difficulty returning to sleep. This is the first time the FDA has approved a drug for this condition. Intermezzo should only be used when a person has at least four hours of bedtime remaining. It should not be taken if alcohol has been consumed or with any other sleep aid. Zolpidem tartrate was first approved in the United States in 1992 as the drug Ambien. Intermezzo is a lower dose formulation of zolpidem. The recommended and maximum dose of Intermezzo is 1.75 milligrams for women and 3.5 mg for men, taken once per night. The recommended dose for women is lower because women clear zolpidem from the body at a lower rate than men. The approval is based on two clinical trials involving more than 370 patients. In the studies, patients taking the drug had a shorter time to fall back asleep after waking compared to people taking an inactive pill (placebo). The most commonly reported adverse reactions in the clinical trials were headache, nausea and fatigue.