FDA warns of rare, odd reactions to sleep drugs

Posted: March 15, 2007

WASHINGTON - Sleeping pills prescribed to millions of people may sometimes cause sleep-driving and other odd behaviors as well as rare but life-threatening allergic reactions, federal health officials warned yesterday.

Sleep-driving is a more complex version of sleepwalking: getting up in the middle of the night and going for a drive, with no memory of having done so.

The Food and Drug Administration wouldn't say exactly how many cases of the side effect it had linked to insomnia drugs, but neurology chief Russell Katz said the agency uncovered more than a dozen reports - and was worried that more were going uncounted.

Given the volume of prescriptions for insomnia drugs, Katz called the problem rare, and said he was unaware of any deaths. But because sleep-driving is so dangerous - and there are precautions that patients can take - the FDA ordered the makers of 13 drugs to take a series of strict new steps.

Doctors in the United States wrote 57 million prescriptions for insomnia drugs in 2006, though sales slipped briefly after initial reports of bizarre behavior associated with the medicines, David Amsellem, an analyst at Friedman Billings Ramsey in Arlington, Va., said.

Debate about risks intensified after Rep. Patrick J. Kennedy (D., R.I.) crashed his car into a barrier near the Capitol in May. He said he had taken Ambien and, for nausea, Phenergan, which also acts as a sedative. He said he had no memory of the event.

Americans spent $3 billion last year just on Ambien and Lunesta, the two most advertised drugs in the nation.

Sidney Wolfe, health research director at the Washington-based consumer group Public Citizen, said an advertising war had encouraged many people to take sleep medicines even though they did not need them.

"The myth has been created by the industry that a huge portion of the population has sleep disorders," Wolfe said in an interview yesterday.

In addition to Ambien, made by Sanofi-Aventis, and Lunesta (Sepracor), the FDA listed the affected drugs as Butisol Sodium (MedPointe Pharmaceuticals), Carbrital (Parke-Davis), Dalmane (Valeant Pharmaceuticals), Doral (Questcor Pharmaceuticals), Halcion (Pharmacia & Upjohn), Placidyl (Abbott), ProSom (Abbott), Restoril (Tyco Healthcare), Rozerem (Takeda), Seconal (Eli Lilly), and Sonata (King Pharmaceuticals).

The companies were told to:

Put warnings on their labels about rare but serious side behavioral effects that include sleep-driving and less dangerous "complex sleep-related behaviors" such as making phone calls, fixing and eating food, and having sex while asleep.

Also warn on labels about rare but life-threatening allergic reactions, as well as severe facial swelling, both of which can occur the first time the pills are taken or anytime thereafter.

Starting this week, send letters to doctors notifying them of the new warnings.

Beginning later this year, include with all prescription sleeping pills medication guides that spell out the risks in easy-to-understand language.

The FDA's Katz stressed that any of the 13 drugs - known as "sedative-hypnotics" - can cause sleep-driving. To lower the risk, he advised patients to never take a prescription insomnia drug with alcohol or another sedative, or take higher-than-recommended doses.

"We really want people to know these things can occur, and these sleep behaviors can be . . . mitigated by behaviors the patients can control," he said.

Read the FDA announcement via

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