WASHINGTON — The Food and Drug Administration announced Thursday that people prescribed the sleeping pill Lunesta should be starting with half the current recommended dose, part of the agency’s continuing effort to reduce sleep aids’ risky side effects, such as drowsiness while driving.
The agency recommended a new starting dose of one milligram, down from two milligrams, and told the pill’s manufacturer, Sunovion Pharmaceuticals, to change its labels to reflect that. Using lower doses means less of the drug will remain in the blood in the morning hours, reducing the risk that people who take it will be impaired while driving. The dose can later be increased to two or three milligrams if needed, the agency said.
According to IMS Health, a health care services company, about 55 million prescriptions for sleep aids were dispensed in the United States in 2013. Lunesta represents a relatively small part of that market, with about three million pills prescribed.
It was not the first time the agency reduced the recommended dose of sleeping pills. In January 2013, the agency said that doses of Ambien and other sleeping pills that contain zolpidem should be halved for women. The agency also told manufacturers that labels should recommend that health care providers “consider” prescribing lower doses for men.
In the case of Lunesta, the agency is recommending lower doses for men and women.
“The F.D.A. is looking at the data as it comes out and making sure we understand that many sleeping pills are not as benign as we assume,” said Dr. Daniel J. Carlat, an associate clinical professor of psychiatry at Tufts University. “Lower doses can prevent next-day sleepiness and head off big problems, like car accidents.”
The change on Thursday was based partly on findings from a study of 91 adults by the Surrey Clinical Research Center in Britain, whose findings were published in the Journal of Clinical Psychopharmacology in 2012. The F.D.A. said it showed that taking three milligrams of Lunesta, whose active ingredient is eszopiclone, was associated with severe impairment of memory and motor skills the morning after taking the drug, compared with a placebo. The study found that the earlier recommended dose of two milligrams could hamper driving, memory and coordination for up to 11 hours after the drug was taken. Patients often did not know they were impaired.
Dr. Ellis F. Unger, an official at the agency’s Center for Drug Evaluation and Research, said the change was made because “data from clinical trials and other types of studies have become available, which allowed the F.D.A. to better characterize the risk of next-morning impairment with sleep drugs.”
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F.D.A. Recommends Lower Dose of the Sleeping Pill Lunesta – New York Times