Zolpidem-containing medicines regulatory update

EMA's Pharmacovigilance Risk Assessment Committee (PRAC) began a review of zolpidem-containing medicines for short-term relief of insomnia following concerns that some patients may experience drowsiness and slower reactions the day after taking the drug. The review will consider whether lower doses of zolpidem could reduce the likelihood of reduced mental alertness and impaired driving ability and whether a dose reduction should be considered in certain patients. The Italian Medicines Agency (AIFA) requested the review.

The drugs include generics, as well as Ambien and Ambien CR from Sanofi; Edluar from Meda and Orexo; and Zolpimist from NovaDel. The ECR Pharmaceuticals Co. Inc. subsidiary of Hi-Tech Pharmacal Co. Inc. (NASDAQ:HITK, Amityville, N.Y.), has rights to manufacture and commercialize ZolpiMist in the U.S. and Canada. ...