Zolpidem-containing medicines regulatory update
EMA's Pharmacovigilance Risk Assessment Committee (PRAC) recommended that the product information of zolpidem-containing medicines used for short-term treatment of insomnia further highlight the risks of impaired driving and mental alertness and strengthen warnings and precautions to minimize these risks. PRAC found that the benefit-risk balance of the drugs remain positive and said the recommended daily dose should remain at 10 mg and "must not be exceeded." PRAC said patients should take the lowest effective dose in a single intake just before going to bed and should not take the medicine again during the same night. The committee recommended avoiding activities that require mental alertness until 8 hours after taking zolpidem and said the sleep drug should not be taken with other medicines that have a CNS effect or with alcohol or other substances that affect mental function.
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. ...