FDA Label Changes for Zolpidem Products

Susan Jeffrey


May 14, 2013

The US Food and Drug Administration (FDA) today announced it has approved label changes specifying new dosing for products containing zolpidem (Ambien, Ambien CR, and Edluar), all widely prescribed sleep medications, because of the known risk for next-morning impairment with these drugs.

The agency is also warning against driving or other activities requiring mental alertness the day after taking extended-release zolpidem (Ambien CR) at the 6.25-mg or 12.5-mg dose because drug levels can remain high enough to impair these activities, a new statement from the FDA notes. This recommendation has been added to the "Warnings and Precautions" section of the physician label and the patient medication guide for Ambien CR.

This update is a follow-up to one issued in January 2013 and includes revised dosing recommendations previously stated in that communication, the FDA notes. Specifically, the FDA recommended that the initial dose of immediate-release zolpidem products Ambien and Edular is 5 mg for women and either 5 mg or 10 mg for men.

The recommended initial dose for extended-release zolpidem, Ambien CR, is 6.25 mg for women and either 6.25 or 12.5 mg for men.

If lower doses are not effective, the dose can be increased to 10 mg for immediate-release products and 12.5 mg for extended-release zolpidem, the FDA communication notes. "However, use of the higher dose can increase the risk of next-day impairment of driving and other activities that require full alertness."


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