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FDA Recommends Low Zolpidem Doses to Prevent Morning Effects

In January 2013, the Food and Drug Administration (FDA) put out a warning to consumers and healthcare providers regarding the insomia drug, zolpidem.  Zolpidem is sold under the brand names Ambien, Ambien CR, Edluar, and Zolpimist. Zolpidem is normally taken at night to help with sleep but new data suggest that patients may still have the drug in their system the next morning.  While patients taking zolpidem may think they are fully awake, the drug's effects may still be present.  The warning states that zolpidem doses taken before bedtime may impair driving of motor vehicles and other daily activities that require attentiveness and alertness.

Current safety data suggest that the long-acting formulations of zolpidem (Ambien CR) pose the greatest risk for morning impairment.  Women seem to be more at risk since zolpidem is removed from their bodies at a slower rate than in men.  The FDA is now requiring drug manufacturers of zolpidem to lower the recommended initial zolpidem doses for women to 5mg (decreased from 10mg) for the immediate-release products Ambien, Edluar, and Zolpimist and 6.25 mg (decreased from 12.5 mg) for Ambiend CR.  The same lower initial doses for men can also be considered.  The does of Intermezzo, a new zolpidem product that is intended to be taken during the night upon awakening, remains unchanged.  The FDA is currently evaluating whether other insomnia medications are also associated with a risk of next-day impairment.

For more information, please see the warning on the FDA website:  http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm322743.htm

Additional information about zolpidem is available from the National Institutes of Health: http://www.nlm.nih.gov/medlineplus/druginfo/meds/a693025.html

 


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