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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