FDA Alerts
FDA Approves Label Changes for Zolpidem Products
The US Food and Drug Administration (FDA) is notifying the public that FDA has approved label changes specifying new dosing recommendations for zolpidem products (Ambien, Ambien CR, and Edluar), which are widely prescribed sleep medications.
FDA Approves Insomnia Drug Intermezzo
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.