Gender-Based Dosing For Insomnia Drugs Dissected In NEJM
This article was originally published in The Pink Sheet Daily
CDER officials explain the rationale behind new labeling on zolpidem-containing immediate- and controlled-release products that halves the recommended dose for women. Labeling changes include a new precaution against next-day driving following use of Sanofi’s Ambien CR.
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Sanofi's sleeping pill has been revised once again in an update that also limits the recommended dosing.
Agency will require driving simulation studies for all new sleep aids and is asking sponsors of currently approved products to conduct such trials. FDA is directing zolpidem-containing product manufacturers to make labeling changes based, in part, on driving data submitted for Transcept’s Intermezzo.
Indication for insomnia characterized by middle-of-the-night awakening followed by difficulty returning to sleep is a first.