FDA Warns of Sleep Aids' Strange Effects
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You can't watch an hour of television without seeing an ad for a drug. In fact, if drug advertising were pulled, it might threaten the entire broadcast industry.
Among the most popular ads and profitable (3 billion in sales last year) are those for sleep aids such as Ambien and Lunesta. Restful sleep they promise with no side-effects. But wait a minute -- the FDA says there may be a rash of very strange side-effects that people are likely under-reporting out of embarassment. Effects such as sleep-driving and sleep-eating with no memory later of the activities. It sounds like it could make a great excuse if pulled over, but this is serious stuff.
The FDA calls them sleep- related behaviors and is asking the drug manufacturers to strengthen warning labels.
The review was prompted in part, by a story in the New York Times.
Sleep-drivers reported frightening episodes in which they recalled going to bed, but woke up to find they had been arrested roadside in their underwear or nightclothes. The agency said that it was not aware of any deaths caused by sleep-driving.
Some of the effects include an allergic reaction or facial swelling, but some people have been seen weaving through traffic, or having a corn beef sandwich at 3 am, sleep-walking, hallucinations, violent outbursts, making phone calls, even purchasing items over the internet have been noted.
Rep. Patrick Kennedy of Rhode Island said Ambien made him do it when he was involved in a crash near the Capitol last May.
Ambien and Lunesta top the list of 13 drugs the FDA is reviewing.