FDA approves first insomnia drug for middle-of-the-night waking followed by difficulty returning to sleep

FDA approves first insomnia drug for middle-of-the-night waking followed by difficulty returning to sleep

The U.S. Food and Drug Administration today approved Intermezzo (zolpidem tartrate sublingual tablets) 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.

(More)