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FDA Warns That Morning-After Hazards from Sleeping Pills Could Make Driving Dangerous

Millions of Americans are desperate for a good night’s sleep. They toss and turn, stare at the clock and wake up feeling exhausted.

That’s why so many turn to sleeping pills. The most widely prescribed sleep aid is zolpidem (Ambien). In fact, it is one of the most popular drugs in the pharmacy.

Most people assume that if they pop a sleeping pill at 10 or 11 pm when they go to bed, they will be good to go in the morning by 6 or 7 am. They don’t think twice about getting in the car and driving to work. An article by FDA officials in The New England Journal of Medicine (online, Aug. 7, 2013) suggests that this assumption may be seriously flawed.

Ambien was first marketed in 1992. The recommended dose was 10 mg. Over the years, different formulations of zolpidem have become available at varying doses. Ambien CR was designed to help people get to sleep quickly with a fast-release outer coating and then help them stay asleep with a sustained-release inner core. The usual dose was 12.5 mg.

More recently, a fast acting formulation called Intermezzo was approved for people who wake up in the middle of the night and need help getting back to sleep. While the FDA was reviewing data on Intermezzo it made an interesting discovery. Even though Intermezzo contains far less of the active ingredient than Ambien, some people still have enough medicine in their bodies by morning to make them potentially hazardous behind the wheel.

Reanalysis of data by the FDA revealed that other formulations also resulted in surprisingly high blood levels of the drug in the morning. For example, eight hours after the 12.5 mg dose of Ambien CR was taken, a third of women and a quarter of men had enough zolpidem in their system to pose a possible driving problem. That may account for some reports on our website such as the following:

“A few years ago I started taking Ambien for a sleep disorder. One day I drove my seven-year-old daughter to school in the morning after taking Ambien the night before. Luckily the school was only a half mile from my house. I didn’t truly wake up until I was sitting in my car in the garage after returning home.

“I found out later that I had repeatedly driven into the curb. One of my tires was flat as a result. My daughter was so traumatized by the incident that she wouldn’t let me drive her to school again.

“I think this drug is dangerous. I got even more than a full night’s sleep but I still turned into a dangerous driving zombie in the morning.”

This kind of report is why the FDA has warned the public about the possibility of driving impairment the morning after taking zolpidem. It has also asked drug companies to lower the dose of zolpidem for women.

Other sleeping pills, including over-the-counter products containing the antihistamine diphenhydramine, may also create a hangover-like effect. It is very difficult for most individuals to judge whether they are impaired.

For more information about sleeping pills and non-drug approaches to insomnia we offer our Guide to Getting a Good Night’s Sleep. Adequate sleep is a keystone of good health, so finding safe ways to overcome insomnia is important.

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About the Author
Terry Graedon, PhD, is a medical anthropologist and co-host of The People’s Pharmacy radio show, co-author of The People’s Pharmacy syndicated newspaper columns and numerous books, and co-founder of The People’s Pharmacy website. Terry taught in the Duke University School of Nursing and was an adjunct assistant professor in the Department of Anthropology. She is a Fellow of the Society of Applied Anthropology. Terry is one of the country's leading authorities on the science behind folk remedies..
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