First Insomnia Drug for Middle-of-the-Night Waking Receives FDA Approval

Intermezzo (zolpidem tartrate sublingual tablets) has received FDA approval for use as needed to manage insomnia characterized by middle-of-the-night waking followed by difficulty in returning to sleep. This is the first time the FDA has approved a drug for this condition.

Intermezzo should be used only when a person has at least 4 hours of bedtime remaining and should not be taken if alcohol has been consumed or with any other sleep aid, the agency noted.

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 mg 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.

As with other sleep medicines, the use of Intermezzo may cause adverse effects, including getting out of bed while not fully awake and performing an activity without knowing it or remembering having done it. The drug is a federally controlled substance because its use can be abused or lead to dependence.

Intermezzo is made by Transcept Pharmaceuticals Inc, Port Richmond, California.