Jan 10 2013
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FDA to Drug Makers: Lower Recommended Doses on Some Sleeping Pills

The U.S. Food and Drug Administration (FDA) yesterday announced it is requiring the manufacturers of widely used sleeping pills that contain the active ingredient zolpidem, to lower current recommended doses. Recommended doses will be required to be lowered on drug labels that doctors use to prescribe medicines and on medication guides given to patients, for the following drugs: Ambien, Ambien CR, Edluar and Zolpimist. FDA is also urging physicians to prescribe the drugs at the lowest dose capable of treating the patient’s insomnia.

The FDA announcement is based on driving simulation and laboratory studies showing that, in some individuals, zolpidem blood levels the morning after use appear capable of impairing driving to a degree that increases the risk of a motor vehicle accident. Reducing deaths from motor vehicle accidents is a priority for the Centers for Disease Control and Prevention. While these deaths declined between 2000 and 2009, car crashes are still among the top ten causes of death for all Americans.

New data is driving the announcement, according to the FDA. “Over the years FDA has received spontaneous adverse event reports of driving impairment and motor vehicle accidents associated with zolpidem, but these reports lacked the information necessary to fully understand whether and how zolpidem affected people’s mental alertness and ability to drive,” said Dr. Unger. “Recently, data from clinical trials and other types of studies have become available, which allowed FDA to better characterize the risk of next-morning impairment.”

According to the FDA, using lower doses of zolpidem means less of the drug will remain in the blood in the morning hours.

Since women eliminate zolpidem from their bodies more slowly than men, the specific information for the drug makers is to post a lowered dose for women and to recommend on the labeling that health care professionals consider a lower dose for men. Data show the risk for next-morning impairment is highest for patients taking the extended-release forms of these drugs. The FDA urges health care professionals to caution all patients who use the drugs about the risks of next-morning impairment for activities that require mental alertness, including driving.

The FDA is requiring that the zolpidem dose for women be lowered from 10 milligrams to 5 mg for immediate-release products (Ambien, Edluar, and Zolpimist) and from 12.5 mg to 6.25 mg for extended-release products (Ambien CR). For men, the FDA has informed the manufacturers that the labeling should recommend that health care professionals consider prescribing these lower doses (5 mg for immediate-release products and 6.25 mg for extended-release products). The drugs are currently available on the market in both the higher and lower dosages.

In a Drug Safety Communication released today, the agency is also reminding the public that zolpidem is not the only sleeping pill that can cause impairment. Drowsiness is listed as a common side effect in the labels of all insomnia drugs, along with warnings that people may still feel drowsy the next day after taking one of these products. And, alertness can be impaired even in people who do not feel drowsy.

People who are currently taking the higher doses (10 mg or 12.5 mg) should continue taking the prescribed dose as directed until discussing a change to their dose with their health care professional.

Many people already take the lower dose. These lower doses of zolpidem (5 mg for immediate-release products and 6.25 mg for extended-release products) will be effective in most women and many men, said an FDA official, though each patient is unique, and the appropriate dose should be discussed with a health care provider.

Tags: Food and Drug Administration, Prescription drugs, Public and Community Health, Safety