By: Leslie Kux and Malcolm Bertoni As we continue to implement the exciting new tools provided by the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), we are inviting interested members of the public to use the … Continue reading →
The U.S. 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.
The U.S. Food and Drug Administration (FDA) is notifying the public of new information about zolpidem, a widely prescribed insomnia drug. FDA recommends that the bedtime dose be lowered because new data show that blood levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving.