FDA Says Ambien Dosage is to Be Lowered for Women

The U.S. Food and Drug Administration issued a statement on Thursday revealing its decision to require that the makers of zolpidem, a common sleep aid drug, reduce the dosage that is given to patients, particularly women. The FDA issued the mandate due to the emergence of information that has shown that the drug can stay in a person's system for several hours after they wake up.

Zolpidem is commonly found in both generic and name-brand sleep aids. Ambien and Ambien CR are probably the most recognizable prescriptions that contain zolpidem, but it is also found in Zolpimist and Edluar, according to the FDA's statement.

Here is some of the key information to have emerged regarding the FDA's decision.

* The FDA is requiring that manufacturers cut the dosage in half for women and some men, citing the possibility that the drug's lingering effects may still make people drowsy or impaired in the morning when they are getting ready to drive to work.

* The Associated Press noted in a report of its own on Thursday that the FDA has different requirements for men and women because women absorb zolpidem more slowly, meaning that the effects of the drug can last longer at higher dosages.

* While the FDA is requiring that the prescribed dosage be cut in half for women, it is merely recommending that men be given the lower dosage.

* The Associated Press also noted that the change in the FDA's approach to zolpidem came after years of allegations and reports of car accidents in which the person involved had taken zolpidem the night before. The FDA could not link the drug specifically to the incidents up until now.

* CNN reported on Thursday that part of the FDA's investigation into zolpidem included running a "large driving simulation study" that found that some drivers who had taken the drug could not operate a car as well as other drivers who hadn't taken the drug or who were taking a lower dose.

* The New York Daily News, with the help of News Wire Services, delved into the actual percentages, and reported that in the study some 10 to 15 percent of women who had taken zolpidem the night before showed impaired driving ability eight hours later. Only 3 percent of men showed the same effects within the same time frame.

* In addition to requiring that the dosage be lowered for women, Dr. Ellis Unger, a director in the FDA's Office of Drug Evaluation, told the New York Daily News that everyone who has to drive a car first thing in the morning or do something else that requires "full alertness" ought to ask their doctor if using sleep aids is appropriate.

Vanessa Evans is a musician and freelance writer based in Michigan, with a lifelong interest in health and nutrition issues.

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