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November 10, 2009

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Editorial: When sleep is dangerous

Thursday, March 15, 2007 | 7:18 a.m.

A year ago we said the Food and Drug Administration should require stronger warning labels for the prescription sleeping pill Ambien, which had been associated with a bizarre disorder known as sleep driving.

On Wednesday the FDA announced that it has requested manufacturers of all "sedative-hypnotic" drugs, which include Ambien, Lunesta, Restoril, Seconal and nine other sleeping-pill brands, to strengthen their labels and take other precautionary measures.

Prompting our opinion last March was a report in The New York Times of an increasing number of incidents in which people who had been driving erratically had no memory of their actions. Blood tests found that people who were making these claims were apt to have Ambien in their systems.

One incident involved a Denver nurse driving late on a 20-degree night, wearing only a nightshirt. After being involved in a fender bender, she fought with police officers. She said the last thing she remembered was going to bed.

Other activity while not fully awake is also associated with this class of drugs, such as preparing and eating food and making phone calls.

Manufacturers say their products are safe if taken as directed. Because people do not always read the labels, we hope the manufacturers comply with the FDA's full request, which includes providing separate, attention-getting handouts for patients whenever they are prescribed sleeping pills.

The FDA has also asked the manufacturers to conduct clinical studies to determine which brands are most associated with the side effects. Such studies should begin at once.

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