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:
