Zolpidem-containing medicines regulatory update

FDA will require manufacturers of zolpidem-containing insomnia drugs to lower the recommended doses for women and suggest that prescribers consider lower doses for men. The requirement follows data from driving simulation and laboratory studies showing that zolpidem blood levels in some patients, especially women, may remain high enough the morning after use to impair activities that require alertness. The drugs include generics and 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. ...