The U.S. Food and Drug Administration (FDA) has called for lowered bedtime doses of popular sleep medications to prevent drowsiness while driving to work in the morning, and during other activities that require alertness, Laura McMullen reports for U.S. News and World Report‘s Health.
In The Philadelphia Inquirer article appearing in The Herald, David Sell writes that the insomnia drug zolpidem that is sold as a generic under the names Ambien, Ambien CR, Edluar, and Zolpimist, was prescribed about 40 million times in 2011.
The FDA is urging patients and doctors to lower the bedtime doses after clinical tests for a recently approved drug were combined with tests involving driving simulators, Sell writes. As a result, the FDA will now require driving simulation tests to be done as part of any new application for insomnia drugs.
The FDA has received 700 reports of ‘impaired ability and/or road traffic accidents,’ which are believed to be the effects of zolpidem, the active ingredient in these sleeping pills. The FDA’s warning specifically addresses women, who are most at risk, and says recommended dosages should be cut from 10 mg to 5 mg in immediate-release pills, and from 12.5 mg to 6.25 mg in extended-release pills. In its safety announcement, the FDA reminded all doctors and patients: ‘To decrease the potential risk of impairment with all insomnia drugs, health care professionals should prescribe, and patients should take, the lowest dose capable of treating the patient’s insomnia.’
Sell notes that in 2011, about two-thirds of sleeping medications contained some form of zolpidem, and he points out that although not all sleeping pills contain the drug, all FDA-approved drugs have label warnings about morning drowsiness.
Sell writes that Dr. Ellis Unger, a director in the FDA’s Center for Drug Evaluation and Research, urges patients to discuss the situation with their doctors before changing any medication regime.
In answer to a reporter’s question in a conference call, Unger said that the FDA was not prompted to call for the lowered dosages as a result of various reports of celebrities using Ambien around the time of car accidents:
‘The new information was not tied to any specific case,’ Usher said, without naming names. But he added in reference to reports of celebrity accidents, ‘We don’t know the time of the accidents, we don’t know the last dosage or whether there was alcohol or other drugs involved.’
Before facing generic competition, two versions of Ambien had nearly $2 billion in sales in 2007 for drug maker Sanofi-Aventis, a company based in Paris, France, and with operations in New Jersey and Malvern, Pennsylvania, IMS health, a health care technology and information company, told Sell.
An Associated Press article appearing on 9news.com in Colorado, says that a recent government study found that 1 in 24 U.S. adults say they recently fell asleep while driving. Health officials believe the number is higher, because some people do not even realize it when they nod off for a second or two behind the wheel, AP writes. Slightly more than 4% of U.S. adults fell asleep while driving at least once in the previous month, said the study, which involved 147,000 adults in 2009 and 2010.
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