U.S. Food and Drug Administration has now given the nod for new, lower-dose labeling for the popular sleep drug Ambien (zolpidem) with a view to reducing daytime drowsiness. Daytime drowsiness poses a problem while doing tough tasks like driving.
This action follows the FDA's request to manufacturers that such drugs should carry instructions to reduce the recommended dose and enable safety information to patients.
FDA has approved these changes because of the known risk of next-morning impairment with these drugs. The purpose of the lowering is to help decrease the risk of next-morning impairment of activities that require alertness. We're particularly concerned about driving. A large fraction of the population drives and driving is an inherently dangerous activity", Dr. Ellis Unger, director of the Office of Drug Evaluation I at the FDA's Center for Drug Evaluation and Research.