FDA Warns of Sleep Drug Risks
‘Sleep Driving,’ Severe Allergic Reactions Cited
WebMD News Archive
Congressman's Sleep Driving
Capitol Hill Police in Washington, D.C., briefly detained Rep. Patrick
Kennedy (D-R.I.) last spring after he collided with a road barrier while
driving late at night. Officers described him as disoriented.
Kennedy later said he had been taking prescription sleep aids and that he
had no memory of the events. He then checked himself into a drug rehabilitation
Katz said the new warnings were not sparked by Kennedy’s incident. He said
the agency had received more than a dozen reports of complex sleep behaviors in
patients taking the drugs.
Katz refused to share precise numbers of reports or to detail which drugs
were involved. But he said the incidents were likely more common than suggested
by the reports, which come voluntarily from doctors and drug companies.
“Whatever numbers we do get, even for serious events ... are considerably
underreported. So it's very difficult to know exactly how many of these are
occurring,” he said.
In a statement, Ambien manufacturer Sanofi Aventis said warnings on sleep
behaviors, known as somnambulism, were already included in its drug’s
“While complex behaviors associated with somnambulism have been reported,
the information currently contained in the U.S. prescribing information remains
accurate: Somnambulism is a possible rare adverse event that occurred in our
clinical trials at a rate of less than 1 in 1,000 patients,” the company
Sanofi Aventis sold $1.9 billion worth of Ambien and Ambien CR in the first
nine months of 2006, according to the company.
Sanofi Aventis is a WebMD sponsor.
Calls to Sepracor, which makes Lunesta, were not returned.
FDA officials offer the following precautions when using sleep drugs:
- Don't take them with alcohol.
- Don't take more than the prescribed dose.
- Don't take with other sedating medication.