Under pressure from the federal government, drugmakers are revising the labels on Ambien, Lunesta and other popular sleep aids to warn that the pills may result in users driving, eating and even having sex while sleeping, health officials said Wednesday.
The manufacturers of 13 popular medications, taken by millions of Americans, are 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-thanrecommended 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 also may 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 although they had been behind the wheel of their car during the night, they had no recollection of driving.
Car accidents have been linked to its use, including one involving Rep. Patrick J. Kennedy, D-R.I., 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 published a study on the strange side effects and is working on another.
Schenck emphasized that the incidents are rare. They have 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.
Besides Ambien and Lunesta, the other medicines to receive warnings are: Butisol Sodium, Carbrital, Dalmane, Doral, Halcion, Placidyl, ProSom, Restoril, Rozerem, Seconal and Sonata.
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 the drugs are used too commonly. Patients should first try inducing sleep by avoiding alcohol late at night, eating earlier in the evening and avoiding overly exciting TV shows before bedtime, suggested Dr. Phil Buescher, who prescribes sleep aids to patients at Union Memorial Hospital in Baltimore.
Sleep specialists, however, emphasize the drugs’ safety and effectiveness.
“Just as likely for many people, it’s simply the amnesia that goes along with deep sleep or with taking these medications,” said Dr. David Neubauer, a sleep specialist who has worked as a paid consultant for several sleep-aid manufacturers. He also has served on an expert committee that advises the FDA about the drugs.