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Thursday, March 22, 2007
FDA Demands Warning Labels on 'Sleep-Driving' Pills
Almost a year after Rep. Patrick Kennedy made headlines when he crashed his car after taking Ambien, federal health officials recently warned that all prescription sleeping pills might sometimes cause sleep driving.
It's a modern-day version of sleepwalking, except it's potentially lethal: getting up in the middle of the night and going for a drive —with no memory of doing so.
The Food and Drug Administration would not reveal the exact number of sleep-driving cases it had linked to insomnia drugs, but neurology chief Dr. Russell Katz said the agency discovered more than a dozen reports —and is concerned that more are going uncounted.
Katz called the problem rare, despite the millions of prescriptions for insomnia drugs, and said he was unaware of any deaths. But the FDA ordered a series of strict new steps because sleep driving is so dangerous, and there are precautions that patients can take.
Manufacturers of 13 sleep drugs must put warnings on their labels about two rare-but-grave side effects:
• sleep driving, and the other, less dangerous "complex sleep-related behaviors," such as making phone calls, fixing and eating food, and having sex while still asleep.
• life-threatening allergic reactions, as well as severe facial swelling, both of which can occur either the first time the pills are taken or anytime thereafter.
US doctors will soon begin getting letters notifying them of the new warnings.
Sometime this year, all prescription sleeping pills will be accompanied with special pamphlets called "Medication Guides" that make the risks clear, in easy-to-understand language.
Last May, sleep-driving made headlines when Kennedy, D-R.I., ran his car into a security barrier outside the U.S. Capitol after taking Ambien and a second drug, Phenergan, an anti-nausea pill that also acts as a sedative. Kennedy has no memory of the event. After pleading guilty to driving under the influence of prescription drugs, he was sentenced to court-ordered drug treatment and a year's probation.
Katz stressed that Ambien isn't the only insomnia drug that can cause sleep driving; any of the class known as "sedative-hypnotics" can. He advised patients to never take any prescription insomnia drug along with alcohol or any other sedating drug, and not to take higher-than-recommended doses of the pills.
"We really want people to know these things can occur,” he said, “and these sleep behaviors can be perhaps to a large extent mitigated by behaviors the patients can control."
The FDA also recommended that manufacturers conduct clinical trials to figure out if some insomnia drugs may be riskier than others.
The drugs are: Ambien; Butisol sodium; Carbrital; Dalmane; Doral; Halcion; Lunesta; Placidyl; Prosom; Restoril; Rozerem; Seconal; Sonata.
Less than one in 1,000 patients in Ambien studies reported somnambulism, a scientific term that includes the sleep behaviors flagged by the FDA. The side effect has remained similarly rare since large sales began.
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