FDA Drug Safety Podcast: FDA approves new label changes and dosing for zolpidem products and a recommendation to avoid driving the day after using Ambien CR

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Narrator: Welcome to the FDA Drug Safety Podcast from the Division of Drug Information. Today’s topic: FDA approves label changes for zolpidem products, including new dosing and a recommendation to avoid driving the day after Ambien CR use. This update is in follow-up to the FDA Drug Safety Communication “Risk of next-morning impairment after use of insomnia drugs; FDA requires lower recommended doses for certain drugs containing zolpidem” issued on January 10, 2013.

Karla Waters, a Consumer Safety Officer in the Division, will provide you with additional information about this Communication.

Karla Waters: On May 14, 2013 the FDA notified the public that the Agency 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,  brand name 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 or 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, such as 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 or 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.

Narrator: Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information.  A link to previous communications and this communication, including the drug labels for zolpidem products Ambien, Ambien CR, and Edluar can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

Prescribers, be sure that your patients are filling their mail-order prescriptions at legitimate online US pharmacies by guiding them to the BeSafeRx online pharmacy map and other resources on FDA’s website.

And follow us on Twitter @FDA_Drug_Info for up to the minute important drug information.  Know the moment it happens. 

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