FDA to Study the Effects of Sleep Aids and Drowsy Driving
According to the New York Times, the U.S. Food and Drug Administration is beginning to show an interest in how sleep drugs that cause drowsiness may affect next day driving.
The Need for a Government Conducted Sleep Aid and Driving Safety Study
While most pharmaceutical companies conduct studies to observe how next day drowsiness caused by sleep aids may affect a patient’s ability to drive, these studies are normally done from a marketing standpoint and are considered to have little influence on whether a drug will be approved by the FDA.
With an FDA funded study, the government can begin to not only address how sleep aids may affect different people, but also more clearly define what constitutes sleep aid driver impairment.
Issues with Sleep Aids and Driver Safety
- According to Today, roughly 60 million prescriptions for sleep aids were filled in the U.S. last year.
- Currently, law enforcement faces a bit of a struggle when determining how best to prosecute drivers impaired by sleep aids, especially when the drugs are prescribed or when the effects of the drugs have lingered into the next morning.
- The New York Times cites a 2007 survey conducted by the U.S. government which found that almost 5 percent of daytime drivers tested positive for prescription and over-the-counter sleep aids.
Recent FDA Interest in Sleep Aids and Next Day Driving
- Last month, the FDA rejected an application by Merck requesting the approval of a new sleep aid drug after testing showed patients who had taken the drug had trouble driving the following day.
- In May of this year, the FDA began warning people of how taking allergy drugs like Benadryl can affect a person’s ability to drive, even into the following day.
- The FDA has also done studies that have determined the effects of sleep aids may vary from person to person. For example, a study in 2011 found that drowsiness tends to linger longer in women.
- In connection to such research, the FDA ordered that manufacturers of zolpidem (Ambien) halve all dosages of the drug when prescribed to women.
Contact an Experienced Product Liability Attorney
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