Washington, DCThe US Food and Drug Administration (FDA) has approved label changes specifying new dosing recommendations for zolpidem products (Ambien, Ambien CR, and Edluar), which are widely prescribed sleep medications. In a statement issued Tuesday, the FDA stated it has approved these changes because of the known risk of next-morning impairment with these drugs.
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The 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).
In November 2012, a study conducted by researchers at the Mayo Clinic in Rochester, MN, found that hospitalized patients who were administered Ambien as a sleep aid had a greater risk of falling in the hospital than those patients who were not given the drug. The study was published in The Journal of Hospital Medicine (11/19/12). As a result of the study, the Mayo Clinic decided to phase out in-patient use of Ambien and seek other sleep aid alternatives. The study, while finding an association between Ambien use and falls, did not establish a cause and effect relationship between the two.
The FDA is continuing to evaluate the risk of impaired mental alertness with other insomnia drugs, including over-the-counter drugs available without a prescription.