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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
*A walk in the desert*
I was prescribed Ambien in May of 2018.
Shortly after taking the generic for Ambien
I found myself in legal issues and unsure why... The only thing I can say, is "this isn't like me" I don't know why I am doing this. I am 26 and have two children and had a spouse at the time. I have my emt/ff and worked as an EMT. After the legal charges I soon lost my husband, job, and can now face losing my children and my license for my emt. I never linked what I have done on Ambien until late July of 2018. I had went to the hospital in globe Arizona to visit a friend after a major surgery and stayed over night at the hospital. I was unable to sleep with all the machines and commotion of the hospital setting. Well, I have taken my ziplodim then got on the hospital couch to go to sleep never realizing that I soon was going to become a patient as well. I was told that I got up around two and I wanted to go get doughnuts and I have no recollection of why or really even leaving the hospital the only thing I vaguely remember was the walk I started walking and decided to take a "short-cut" through the desert and this is where my memory gets even more foggy. As I was walking I fell in the desert and hurt my ankle to where I need surgery. Now I have a blown pupil on my right side. I remember waking up in the desert and thought I can't get up I am going to die here and then I got up and fell four more times. I finally got myself to my house to get my car because I couldn't find my phone I lost it in the desert.... I drove myself to find my phone and got my car stuck. I do not remember the drive. The clerk later at cirlce k stated I seemed like I was sleep walking and was a zombie. I have no recollection of this. Please call me at 928-940-9716 for more of this story. This drug needs a stronger label on this bottle!

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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