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FDA: Strange Side Effects with Popular Sleep Aids

Popular sleeping pills can cause odd side effects such as eating and driving while asleep, said the Food and Drug Administration in a statement yesterday, adding that the 13 widely used drugs will get sterner warning labels.

In addition to the heightened warnings, the FDA is requiring manufacturers of drugs like Ambien and Lunesta to create patient fliers that will contain general information on how to safely use the medications.

The FDA has been working with drug makers since December 2006 to revise the labeling and inform healthcare professionals and consumers of the risk of severe allergic reaction and strange sleep-related behaviors associated with the 13 drugs.

“Hopefully this will make doctors think twice before blindly giving patients a prescription,” said sleep expert Dr. Mark W. Mahowald, director of the Minnesota Regional Sleep Disorders Center.

Soaring Popularity

Prescriptions for sleep aids like Ambien and Lunesta have soared in recent years, in part due to aggressive marketing campaigns. Last year alone, drug makers spent more than $600 million in print, television, and other advertising.

Those efforts have not been in vain. According to recent statistics, 44 million prescriptions were written for this class of drugs last year in the United States—more than half of which were for Ambien.

“I personally think the extent of advertising has just been unconscionable,” said Dr. Mahowald.

Dr. Mahowald and colleagues at the center have been involved in a study of patients who developed sleep-eating while taking Ambien. Patients who develop the problem have no memory of the event, and as a result some gained as much as 100 pounds before realizing they were eating in their sleep.

The 13 Drugs

The labeling changes will affect the following medications:

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

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