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 tom.burton@wsj.com
Subscribe to WSJ: http://online.wsj.com?mod=djnwires