FDA Takes Action on Ambien; Concedes Women at Greater Risk

In an article published in Marie Claire in October 2013, the dangerous side effects of Ambien was discussed – particularly sleep driving, a form of sleep walking in which users get into their cars and drive without consciously intending to do so.  The article profiled a number of tragic incidents resulting from this dangerous side effect.  It also raised concerns that, according to recent studies, female users of Ambien were at greater risk.

The announcement by the FDA substantiates those concerns.  According to the release, women appear to be more susceptible to this risk [of next day impairment] because they eliminate zolpidem from their bodies more slowly than men.”  In a landmark shift, the FDA is now recommending that manufacturers lower the recommended dose of zolpidem for women from 10 mg to 5mg for immediate release products (Ambien, Edluar and Zolpimist) and from 12.5 mg to 6.25 mg for extended release products (Ambien CR).

For more on the dangers of Ambien side effects, read the Marie Claire story to include a discussion on Kerry Kennedy’s Ambien-related car crash.

Update:  On a press briefing call in December 2013, Dr. Ellis Unger of the FDA’s Office of Drug Evaluation clarified the rationale for the FDA’s decision to lower the recommended Zolpidem dosage for women.  He explained that it was not based on any one specific incident but on an accumulation of knowledge over a period of time, including recent driving simulation and other studies.  By lowering the dosage, Dr. Unger explained, the FDA hopes to reduce the incidence of not just “next day impairment” but also of “sleep driving,” the side effect I highlighted in a recent Marie Claire story.

REFERENCE:  WALL STREET; 10 JAN 2013; Kai Falkenberg, Forbes Staff

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