A new Ambien sleeping pill warning announced by The Food and Drug Administration on Thursday, Jan. 10 has been circulating news sites, and has been one of the to trending topics on Twitter. Fox8.com reported that the FDA has announced that they are requiring manufacturers of insomnia products, such as Ambien, Edluar and Zolpimist, to lower their current recommended doses.
The sleeping pill Ambien contain an active drug ingredient called zolpidem, which causes drowsiness. Researchers have discovered that Ambien leaves high levels of zolpidem in the blood of patients the morning after a dose, so much so that it affects some user's’ cognitive skills, including their ability to drive.
The FDA's new Ambien warning claims that lowering doses of zolpidem will cut down on the amount of the drug found in the bloodstream the next morning. Studies have also proven that the recommended dose should be lower for women, because they don’t process zolpidem out of their system as quickly as men.
The Food and Drug Administration strongly recommends the dosage levels of zolpidem for women be lowered to 5 milligrams from 10 milligrams for immediate-release products and to 6.25 milligrams from 12.5 milligrams for extended-release products. Patients who use the extended-release forms of these drugs have an even higher risk for next morning impairment, according to the FDA.
The FDA said new labeling on the insomnia products will let doctors know they should consider a lower dose for men, especially for those who are having difficulty concentrating the next morning. And all patients, the FDA said, should be told about the possible “morning after” risks.
“Patients should also read the medication guides and understand the benefits and risks of these drugs,” said Dr. Ellis Unger of the FDA’s Center for Drug Evaluation and Research. “We believe that by lowering these doses, we can decrease the side effects that happen the morning after.”
The new doses apply to all insomnia treatments containing the drug zolpidem, which is sold under the brands Ambien, Edluar and Zolpimist.
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