FDA Requiring Lower Recommended Dose For Certain Sleep Drugs Containing Zolpidem

The Food and Drug Administration Jan. 10 announced that it is requiring the manufacturers of sleep drugs containing zolpidem to lower current recommended doses.

The drugs include Ambien, Ambien CR, Edluar, and Zolpimist, the agency said. Ambien and Ambien CR also are available as generics. Ambien and Ambien CR are made by Paris-based Sanofi; Edluar is made by Somerset, N.J.-based Meda Pharmaceuticals Inc.; and Zolpimist is made by Bridgewater, N.J.-based NovaDel Pharma Inc.

FDA said new data show that zolpidem blood levels in some patients may be high enough the morning after use to impair activities that require alertness, including ...