FDA Warns of Sleep Drug Risks

The agency said it has asked the makers of more than a dozen drugs to alter drug labels and officially warn doctors and patients of the risks.

Allergic reactions included in the warning are anaphylaxis (a severe, life- threatening allergic reaction) and angioedema (severe facial swelling).

Both anaphylaxis and the sleep behaviors were described by officials as “rare.” The agency said no deaths have been reported as a direct result of taking the drugs.

Still, officials decided to ask for the warnings after a review showed all medications in the class of drugs known as sedative-hypnotics carried the risk. This class of drugs induces and/or maintains sleep.

Russell Katz, director of the FDA's Division of Neurology, said the agency received reports of severe facial swelling in some patients who had taken Rozerem, the most recently approved prescription sleep drug.

But a review showed “they all have cases reported with all the drugs,” he told reporters in a telephone conference call.

The agency said it would ask companies to send letters to doctors and also to issue new “medication guides” to patients filling prescriptions for the drugs.

The FDA has also requested that manufacturers create Patient Medication Guides for their products.

It recommends that manufacturers perform clinical studies into complex sleep- related behaviors connected to use of the individual drugs.

Strange Nighttime Behavior

Some patients who’ve taken the drugs, which include popular brands like Ambien and Lunesta, have reported participating in behaviors akin to sleepwalking, but far more complex.

They include preparing and consuming meals, talking on the telephone, or even having sex -- all with no memory of the events.

“They’re rare, but because they’re intended to put people to sleep ... it might be difficult for a patient to know they’re having this event if they’re falling asleep or report to someone that they’re having this event if they’re asleep,” said Katz.

FDA’s warnings include the following drugs:

• Ambien/Ambien CR
• Butisol Sodium
• Carbrital
• Dalmane
• Doral
• Halcion
• Lunesta
• Placidyl
• Prosom
• Restoril
• Rozerem
• Seconal
• Sonata

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 ishonest 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.

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