Intermezzo approved for as-needed treatment of sleep interruptions

The Food and Drug Administration (FDA) has approved a new sleep aid for people who wake in the middle of the night. Intermezzo was approved Nov. 23 for as-needed treatment when nighttime awakening is followed by difficulty returning to sleep. It’s the first drug used to treat insomnia with middle-of-the-night dosing. Intermezzo is to be taken at least four hours prior to awakening, the FDA said.

Driving safety was demonstrated through a driving study. Men and woman were tested. There was no significant effect on driving four hours after taking Intermezzo. However, the FDA said a significant effect was observed after three hours.

The key ingredient in Intermezzo is zolpidem tartrate. Zolpidem tartrate has been marketed as Ambien since 1992, and under several generic formulations. The FDA said the recommended dose for Intermezzo is 1.75 mg for women and 3.5 mg in men.

Other methods are also used to treat insomnia. Read more about sleep disorders and sleep medication from the American Academy of Sleep Medicine.