WASHINGTON -- Under pressure from the federal government, drug makers are revising the labels on Ambien, Lunesta and other popular sleep aids to warn that the pills may result in driving, eating and even having sex while sleeping, health officials said yesterday.
The manufacturers of the 13 popular medications are also preparing information bulletins for users that will highlight the possibility of bizarre nighttime side effects.
The Food and Drug Administration requested the action to discourage patients from taking higher than recommended doses or combining use with alcohol consumption. Dr. Russell Katz, director of the agency's neurology division, said it had received more than a dozen reports of strange behavior.
"We don't think that these [side effects] are sufficiently frequent that it would cause us to re-evaluate whether or not the drugs should be on the market," he said. "But we do believe the labeling needs to be changed."
The side effects may also include trouble breathing and other severe allergic reactions, Katz said, but it's the strange sleep-time behaviors that have prompted scientific study and attracted national attention.
Patients taking Ambien, in particular, have said they woke up to find themselves gorging on food. Some cooked while asleep. Others talked on the telephone while asleep or had sex. Some others learned afterward that they had been behind the wheel of their car during the night, but they have no recollection of driving.
Car accidents have been linked to its use, including one involving Rep. Patrick J. Kennedy, a Rhode Island Democrat, who later sought treatment for substance abuse.
"Two of our patients started fires in their kitchen, two drove automobiles - that's serious," said Dr. Carlos Schenck, a senior staff physician at the Minnesota Regional Sleep Disorders Center, who has published a study on the strange side effects and is working on another.
Schenck emphasized that the incidents are rare. In the past five years, only 35 of his patients have had the side effects, he said. They tended to occur in young and middle-age women taking other medications at the same time, and they followed from use of Ambien, not other sleep aids.
"With very few other exceptions, it's the Ambien," Schenck said. "So I question why the other" sleep aids are receiving warnings and medication guides.
Sleeping pills are widely used, with Ambien the most popular prescription sleep aid. Doctors wrote nearly 50 million prescriptions for sleep medications last year, generating $3.6 billion in sales, according to IMS Health, a health care information company.
Some physicians complain that the drugs are used too commonly.
Before taking one of the drugs, patients should try inducing sleep by avoiding alcohol late at night, eating earlier in the evening and turning off an overly exciting TV show before bedtime, Buescher said.
Sleep specialists, however, emphasize the drugs' safety and effectiveness. Schenck continues prescribing Ambien to two patients who have had the side effects because the drug treats their severe insomnia so well.
Dr. David Neubauer, a sleep medicine specialist in the Department of Psychiatry and Behavioral Sciences at Johns Hopkins Medicine, said the problem might not be that patients are undertaking complex behaviors while sleeping.
"Just as likely for many people, it's simply the amnesia that goes along with deep sleep or with taking these medications," said Neubauer, who has worked as a paid consultant for several sleep aid manufacturers. He has also served on an expert committee that advises the FDA about the drugs.
The FDA first asked drug makers to change the labels and draft medication guides in December. It asked the companies to submit their revisions for review by May.
Katz said the FDA acted after receiving more than a dozen reports of strange nighttime incidents and determining that all of the sleep aids could cause the side effects.
Ambien's manufacturer, Sanofi Aventis, has altered the drug's label and plans to notify physicians through a "Dear Healthcare Professional" letter and an education effort. Sanofi spokeswoman Lisa Kennedy said company studies indicated that somnambulism took place in less than one in every 1,000 patients.
Besides Ambien and Lunesta, the other medicines to receive warnings are: Butisol Sodium, Carbrital, Dalmane, Doral, Halcion, Placidyl, ProSom, Restoril, Rozerem, Seconal and Sonata.