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FDA Investigates Effects of Sleep Aid Drugs on Driving

Aug 14, 2013

Federal health officials are now looking into whether prescription sleep aid drugs like Ambien are causing people to get too much sleep, and what kind of safety risks that this may pose, particularly when one of these people is behind the wheel.

According to The New York Times, drugs like Ambien may be effective at helping one to fall sleep — though there are other serious side effects to ponder — but these sleep aid drugs may still be working the next morning. This could result in a drowsy drive to the office, which puts the driver, not to mention other drivers, as well as passengers and pedestrians, at risk of serious injury or death.

The Times highlights an example involving the ex-wife of New York Gov. Andrew Cuomo, who swerved into a tractor-trailer with her automobile the morning after she had taken Ambien to help her fall asleep. The report notes that the U.S. Food and Drug Administration (FDA) is trying to quantify the overall impact on drivers of sleep aid drugs like Ambien and other prescription drugs.

The National Highway Traffic Safety Administration (NHTSA) recently conducted a survey on drug use among drivers and found that just more than 6 percent of drivers were on some form of prescription drug.

More than 60 million prescriptions for drugs like Ambien are written annually. And lately, The New York Times notes, the FDA has taken action on several fronts that suggest it is concerned about the potency of sleep aid drugs and how they may be affecting the awareness of those who ingest them and wind up behind the wheel of an automobile.

The Times noted three recent examples of the FDA’s skepticism over the safety of sleep aids combined with driving — especially the next day. The regulator:

Rejected a proposed new sleep aid drug from Merck & Co., suvorexant: Regulators expressed concern over a study that found those who took the drug had trouble driving safely the next morning.

Warned against taking over-the-counter Benadryl and driving: The FDA said that the allergy medication’s effects lasted through the morning after it was taken.

Female doses of Ambien halved: The agency ordered that dosage levels for Ambien and its generic form, zolpidem, be cut in half because the effects were too strong.

A lead FDA researcher in this effort to understand the true impact of sleep aid drugs on driving safety told The New York Times that warnings on drugs that discourage driving and using heavy machinery are often ignored.

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