The Food and Drug Administration has decided to require manufactures of Ambien, Ambien CR, Zolpimist, Edluar, and some other prescription sleep-aid medications to reduce their recommended dosages for women by half after laboratory studies and driving tests confirmed risks of drowsiness.
The drugs affected by Thursday's FDA announcement all contain the active ingredient zolpidem, which has been shown to impair alertness – particularly in women – when performing tasks the morning after it was taken, especially tasks that require one's full attention, such as driving.
"The changes are different in women and men," Dr. Ellis Unger, a director in FDA's Office of Drug Evaluation, told ABCNews.com
. "We don't understand why yet, but women are more susceptible to next-morning impairment."
Due largely to the increasingly high-paced nature of American life, the use of sleeping pills that include zolpidem have seen a dramatic surge since being introduced in the United States in 1993.
According to health care information and technology company IMS, approximately 60 million prescriptions for sleep-aid drugs were dispensed in the United states in 2011, a 20 percent increase since 2006. Nearly 40 million of such sleep-inducing medications contained zolpidem.
Dr. Robert Temple, an official in the FDA’s Center for Drug Evaluation and Research, said women on average take longer to metabolize the drug, with 15 percent of female test subjects having a level of zolpidem in their blood hours after they wake the following morning compared with just 3 percent of men.
For years, aftereffects of sleeping pills have circulated among users, which led many industry observers to ask what took the FDA so long to act.
"In this case, the FDA may be behind the eight ball," Daniel Carlat, an associate clinical professor of psychiatry at Tufts University, told the New York Times
. "Few doctors will be surprised hearing about this. They'll say, 'Oh yeah, we've already seen this in our patients.'"
The sentiment was shared by Diana Zuckerman, president of the National Research Center for Women & Families.
"This announcement is at least a decade overdue," Zuckerman told ABC News
. "The FDA's announcement today will save lives, but the agency needs to do more to determine all the risks of Ambien and other sleeping pills."
Though the FDA acknowledged having received approximately 700 reports of driving mishaps involving zolpidem use since its introduction, the agency told the Times that it was not easy to connect the reports with the drug. According to the FDA, some of the complaints came from people who had been drinking alcohol with the medication or had forgotten when they took the pill.
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