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 Requiring Lower Recommended Dose for certain sleep drugs containing zolpidem
The US Food and Drug Administration today announced it is requiring the manufacturers of Ambien, Ambien CR, Edluar and Zolpimist, widely used sleep medications that contain the active ingredient zolpidem, to lower current recommended doses.