FDA Orders Stronger Warning Labels for Ambien, Other Sleep Drugs

Doctors Debate Effect of Labeling

Even as the FDA pushes for stronger labeling, the agency maintains that sleeping drugs do not pose enough of a health hazard to warrant pulling them off pharmacists' shelves.

But some say that a labeling change will likely have little effect on the use of these drugs, which accounted for more than 45 million prescriptions in the United States in 2005.

"It's good to have the information available for patients, though I think they are so inundated with drug-related information that they are not in a position to interpret," says Dr. Greg Anderson, assistant professor of family medicine at the Mayo Clinic in Rochester, Minn.

"As a result of the volume of cautions and warnings on medications, as well as the difficulty they have with interpretation of actual risks, I have a hunch that most people do not bother to read the pharmacy handouts."

Dr. Melvyn Sterling, an internist practicing in Orange County, Calif., agrees that the labeling change may not make a huge impact in overall use.

"The product labeling changes appear reasonable, but I doubt that it will have much of an impact on the use of these medicines," Sterling says. "Patients who suffer with insomnia are likely to be willing to risk the adverse side effects noted, particularly since they are quite uncommon."

And the relatively rare nature of the side effects has some questioning why other drugs with similar side effects are not also subject to stricter labeling.

"What may be disappointing is that the labeling does not cover a large number of compounds that are commonly used off-label as hypnotic in clinical practice," Mignot says, noting that prescriptions for over-the-counter sedative drugs, sedative antidepressants and antipsychotic drugs may represent almost as many prescriptions as leading sleeping pills developed for insomnia.

"Whereas there is no data in this area, I would not be surprised if these other drugs can produce similar complications."

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