FDA Cuts Recommended Dose of Lunesta in Half

The Food and Drug Administration on Thursday cut in half the recommended dose of the popular sleeping pill Lunesta, concluding some patients were impaired the morning after taking it even if they felt fully awake.

Lunesta, made by the Sunovion Pharmaceuticals unit of Japan's Dainippon Sumitomo Pharma Co. Ltd., generated U.S. sales in 2013 of $867 million, according to IMS Health. The drug made its debut in 2005.

The FDA recommended that the beginning dose of the drug be lowered from two to one milligram for men and women.

Just over a year ago, the FDA made a similar cut in the recommended dose for zolpidem. That drug is sold generically and under brand names including Ambien, made by Sanofi. The federal agency said in its statement Thursday that it continues to scrutinize the possible risk of impaired mental alertness with all sleeping pills, include those sold over the counter.

Sanofi didn't immediately respond to a request for comment.

Dr. Ellis Unger, director of the FDA drug office that evaluates sleeping pills, said data from clinical studies had recently become available that allow the agency to better understand the extent of next-morning impairment. Sunovion didn't return a phone call seeking comment on its drug, which generically is called eszopiclone.

Officials said the agency's decision on Lunesta stemmed at least partly from a study of 91 healthy adults ages 25 years old to 40 years old. Compared with a placebo, Lunesta was linked to "severe" next-morning motion and memory impairment 7.5 hours after taking the drug. Some impairment continued for as long as 11 hours, the FDA said. Researchers found that people taking three milligrams of Lunesta the night before could suffer impairment in activities requiring alertness, including driving, even in people "who were often unaware they were impaired," the FDA said.

Similar findings occurred in some tests before Lunesta's 2005 introduction. FDA reviewers in December 2004 wrote that a six-month study of patients taking a three-milligram does of Lunesta showed a 1.3% rate of memory impairment versus a 0% rate in placebo patients.

In January 2013, the FDA recommended lowered dosages for generic zolpidem and brand-name Ambien, generally calling for lower dosages in women and in all patients taking an extended-release form of the drug.

In the case of Lunesta, which doesn't have an extended-release form on the U.S. market, federal officials said they saw no differences in how men and women responded, and that the lower dose recommendations thus apply to all patients.

Write to Thomas M. Burton at [e-mail]

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