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Insomnia Drug Development Programs Must Include Driving Studies, FDA Says

 
• By Sue Sutter

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.

Sponsors of investigational sleep aids will be required to conduct driving simulation studies to assess treatment-related impairment the morning after the drugs’ use, FDA said Jan. 10 in announcing dosing and labeling changes for zolpidem-containing insomnia treatments approved for bedtime use.

The agency is also requesting that driving simulation studies be conducted for currently approved insomnia agents, and it may invoke its authority under the FDA Amendments Act’s safety provisions to...

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