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FDA Cuts Dosage in Half for Ambien–Sleepy Driving Concerns, Lunesta Not Affected

Posted Jan 10 2013 8:55pm

One other item that should be mentioned is the time of night whenimage you take the pill.  The warnings all tell you to not take it too late like at 1 am if you are going to get up at 6 am for example.  Sanofi now can make some additional revenue if they price doesn’t drop for the lower does:)  This is actually a good thing and reactions around the web today said what took so long as this has not been a big secret.  Remember Tom Brokaw who “accidentally” took an Ambien during the day and went to the hospital because he was light headed?  Maybe that helped move this up in priorities at the FDA. 

The order does not apply to Lunesta which is made by another company and have a different active ingredient. (Some Lunesta users chase butterflies though and it is not for little wussy boys-humor).  BD




The Food and Drug Administration announced Thursday that it will require manufacturers of zolpidem, a popular sleeping pill sold as Ambien and Edluar, to reduce recommended dosages amid concerns about morning drowsiness caused by the pills.



In its announcement, the FDA noted that "some patients may be high enough the morning after use to impair activities that require alertness, including driving" and said that "patients with high levels of zolpidem can be impaired even if they feel fully awake." The FDA has received 700 reports of zolpidem leading to "impaired driving ability and/or road traffic accidents."

Sanofi, who manufactures Ambien and Ambien CR, said in a statement that they "have been in contact with FDA on the issue of zolpidem dosing.

"

We agree that individuals taking zolpidem should always talk to their doctor about the most appropriate dose [and] they should never take more than the prescribed dose," the company said. "Sanofi stands behind the significant clinical data demonstrating the safety and efficacy of Ambien."



http://www.usnews.com/news/articles/2013/01/10/fda-cuts-ambien-dosages-in-half-amid-concerns-of-sleepy-driving

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