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FDA Changes Dosing on Ambien, Ambien CR, Zolpidem and Edluar

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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.

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.

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READER COMMENTS

Posted by

on
can be very dangerous for taker or people around taker, especially a stubborn taker who thinks their stable under the influence. Be prepared to call 911 for intervention.

Posted by

on
Seriously Jerry - read the directions. take the medicine - GET RIGHT IN BED. Dont make any plans - go directly to bed. if you know you might be doing something that might require you to be alert - you cant take it. Yes - it takes some personal responsibility but just like when you drink and drive - you cant blame someone else for your intake.

Posted by

on
My doctor prescribed Ambien Cr to take because I had trouble sleeping. After taking 1 ambien I felt as If I had drank a fifth of vodka. I could not walk in a straight line, I spoke in a slurred voice, I was not aware of my surroundings and I personally believe that people who are taking Ambien CR are a risk of killing themselves or others if they attempt to drive a vehicle.

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