FDA Approves Label Changes for Zolpidem Products

Label changes for new dosing recommendations approved for Zolpidem products

/ Author:  / Reviewed by: Joseph V. Madia, MD

The US Food and Drug Administration (FDA) is notifying the public that FDA has approved label changes specifying new dosing recommendations for zolpidem products (Ambien, Ambien CR, and Edluar), which are widely prescribed sleep medications.

FDA has approved these changes because of the known risk of next-morning impairment with these drugs.

FDA is also warning that patients who take the sleep medication zolpidem extended-release (Ambien CR)―either 6.25 mg or 12.5 mg―should not drive or engage in other activities that require complete mental alertness the day after taking the drug because zolpidem levels can remain high enough the next day to impair these activities.

This new recommendation has been added to the Warnings and Precautions section of the physician label and to the patient Medication Guide for zolpidem extended-release (Ambien CR).

Also included in the updated label are the dosing recommendations previously stated in FDA’s January 2013 Drug Safety Communication: The recommended initial dose of certain immediate-release zolpidem products (Ambien and Edluar) is 5 mg for women and either 5 mg or 10 mg for men.

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

If the lower doses (5 mg for immediate-release, 6.25 mg for extended-release) are not effective, the dose can be increased to 10 mg for immediate-release products and 12.5 mg for zolpidem extended-release.

However, use of the higher dose can increase the risk of next-day impairment of driving and other activities that require full alertness.

Review Date: 
May 14, 2013