Insomnia Drug Development Programs Must Include Driving Studies, FDA Says
This article was originally published in Pharmaceutical Approvals Monthly
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.
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Draft guidance describes various analyses and studies that can determine a drug’s effect on driving but doesn’t offer much advice on how to determine when a drug needs to progress to a higher level of scrutiny.
Indication for insomnia characterized by middle-of-the-night awakening followed by difficulty returning to sleep is a first.
Results from a driving impairment study strengthen the case for approval, the company says.