US FDA lowers recommended dose for sleep drugs containing zolpidem

The US Food and Drug Administration yesterday announced it is requiring the manufacturers of Ambien, Ambien CR (both from French drug major Sanofi - Euronext: SAN), Edluar, from Sweden’s Meda (OMX: MEDA A), and Zolpimist from Novadel, widely used sleep drugs that contain the active ingredient zolpidem, to lower current recommended doses of the drug.

Ambien and Ambien CR are also available as generics. 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 driving. The recommendations for Transcept Pharmaceuticals' Intermezzo, which was approved by the FDA in 2011 and already has different doses for men and women, will be unchanged.

Using lower doses of zolpidem means less of the drug will remain in the blood in the morning hours. Since women eliminate zolpidem from their bodies more slowly than men, the FDA has notified the manufacturers that the recommended dose should be lowered for women and that the labeling should recommend that health care professionals consider a lower dose for men.