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Biotech / Medical : Biotech News

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From: Doc Bones5/6/2008 3:06:57 PM
   of 7143
 
To Cut Risks of Sleeping Pills,
Hide Car Keys, Unplug Phone

HEALTH JOURNAL
By MELINDA BECK
May 6, 2008; Page D1

One woman woke up with a paintbrush in her hand, having painted her front door in her sleep. People have set fire to their kitchens while trying to cook, cursed their bosses on the phone and crashed their cars into trees -- all in a sleeping-pill-induced haze and with no memory afterward.

A flurry of such cases prompted the U.S. Food and Drug Administration last year to require that Ambien, Lunesta and other "sedative-hypnotic" drugs carry strong warnings. But that scarcely dampened enthusiasm. U.S. sleep-aid prescriptions grew 10% last year, according to IMS Health, thanks in part to generic Ambien.

Now, an analysis of adverse-event reports filed with the World Health Organization suggests that some side effects of this generation of sleep medication, which debuted in the 1990s, may be nearly as problematic as the older generation, including Halcion, which was banned in some countries.

The WHO Collaborating Center for International Drug Monitoring received 867 reports from 24 countries of people encountering amnesia, often coupled with confusion, agitation and other behavior disturbances, while taking the newer sleeping aids, called nonbenzodiazepines (NBZs) through March, 2007. That compares with 1,032 adverse reports with the older class of benzodiazepines (BZs), even though they have been on the market for decades longer.

"We've moved from one problem drug to another," says Ralph Edwards, director of the Uppsala Monitoring Centre in Sweden, which monitors adverse-event signals for the WHO.

"The older pills are much more likely to cause daytime sedation, addiction and withdrawal symptoms," says P. Murali Doraiswamy, chief of biological psychiatry at Duke University Medical School and the lead author of the study, presented Monday at the American Psychiatric Association conference in Washington. But, he says, the reports of amnesia and erratic behavior appear to be similar with both kinds of drugs. "We still don't have a good handle on how common these events are -- some people may be particularly vulnerable," he says.



A spokeswoman for Sanofi-Aventis, which makes Ambien, the leading brand-name NBZ, says the company couldn't comment since it hadn't seen the report. She says somnambulism occurred in fewer than 1 in 1,000 patients in clinical trials, and wasn't necessarily caused by the medication.

Experts aren't sure what prompts some people to eat, walk, make phone calls or get behind the wheel in their sleep. But some speculate that sleep medication may act on brain circuits unevenly, leaving the parts that govern "automatic" behaviors like eating and driving active while shutting down the centers of judgment and control.

"It's like the parents are away and now the little kids can do whatever they want," says Dr. Doraiswamy. And, as with most dreams, the events aren't being stored in the brain's memory circuits, hence the amensia. "It's like a self-erasing tape," says Mark Mahowald, medical director of the Minnesota Regional Sleep Disorders Center in Minneapolis, Minnesota.

Dr. Mahowald notes that some people do engage in such odd sleep behaviors even when they aren't taking medications. "One common form is for a man to get up to go to the bathroom in his sleep and only make it to the closet. But people seldom report that," says Dr. Mahowald, though he adds that it's far more likely to occur on sleeping medication that off.

Psychiatrist Carlos Schenck, also at the Minnesota Regional Sleep Disorders Center, has studied some 40 cases of Sleep-Related Eating Disorder (SRED), and found that it's more common in women than men and often accompanies a mood disorder. Some patients he studied have cut themselves with knives, consumed inedibles like buttered cigarettes and woken up gasping for air with their mouths full of peanut butter, a particular sleep-eating favorite.

Experts all recommend trying non-drug means to combat insomnia -- such as exercise, stress reduction and avoiding caffeine. But if you need to resort to medication, there are ways to minimize the risks:

One is to get into bed immediately. Sleeping pills can work in 10 or 15 minutes.

Never take more than the maximum dose. Never mix sleeping pills with alcohol. And never attempt to drive while taking them.

"We've had some cases where people are leaving a party, and they're afraid they are going to have insomnia, so they take one before they get in the car," says Dr. Mahowald. He also cautions against taking a sleeping pill if you are the sole caregiver for a small child or are expecting an important phone call. In fact, a ringing phone may trigger a sleepwalking event, so unplug it if possible.

Stash your car keys in an unusual spot, suggests William C. Head, an Atlanta attorney who has defended sleeping-pill users who went on unplanned drives.

Dr. Schenck also suggests putting an alarm on your bedroom door. "That $14 could save your life," he says.

online.wsj.com
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