FDA Warns of Sleep Drug Risks

‘Sleep Driving,’ Severe Allergic Reactions Cited

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Continued

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 clinic.

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 label.

“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 said.

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.
WebMD Health News Reviewed by Louise Chang, MD on March 14, 2007

Sources

SOURCES: FDA: Health Advisory, March 14, 2007. Russell Katz, MD, director, FDA Division of Neurology. Statement, Sanofi Aventis, March 14, 2007. Financial statement, Sanofi Aventis, Oct. 31, 2006.

© 2007 WebMD, Inc. All rights reserved.

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