FDA Warns of Sleep Drug Risks
‘Sleep Driving,’ Severe Allergic Reactions Cited
Congressman's Sleep Driving continued...
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.