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 more popular drugs in the pharmacy.
Most people assume that if they pop a sleeping pill at 10 p.m. when they go to bed, they will be good to go in the morning by 6 a.m. They don't think twice about getting in the car and driving to work. An article by Food and Drug Administration officials in the New England Journal of Medicine (online, Aug. 7) suggests that this assumption might be flawed seriously.
Ambien was first marketed in 1992. The recommended dose was 10 mg. Through 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 when they get 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 systems to pose a possible driving problem.
That might 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 7-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."
This kind of report is why the FDA has warned the public about the possibility of driving impairment the morning after taking zolpidem. It also has asked drug companies to lower the dose of zolpidem for women.
Other sleeping pills, including over-the-counter products containing the antihistamine diphenhydramine, also might create a hangover-like effect. It is very difficult for most individuals to judge whether they are impaired.
Adequate sleep is a keystone of good health, so finding safe ways to overcome insomnia is important. For information about sleeping pills and nondrug approaches to insomnia, we offer a "Guide to Getting a Good Night's Sleep" at PeoplesPharmacy.com.
Joe Graedon is a pharmacologist. Teresa Graedon holds a doctorate in medical anthropology and is a nutrition expert.