The Food and Drug Administration said the starting
dose for the drug taken at bedtime for both men and women should be
the lowest 1 milligram dose, down from the previous 2 mg recommended
starting dose. The agency said the drug could remain in a patient's
system long enough to impair activities such as driving, even if the
person feels fully awake.
"To help ensure patient safety, health care professionals should
prescribe, and patients should take, the lowest dose of a sleep
medicine that effectively treats their insomnia," Ellis Unger, of
the FDA's Center for Drug Evaluation and Research, said in a
The 1 mg dose can be increased to 2 mg or 3 mg if needed, but the
higher doses are more likely to result in next-day impairment, the
Lunesta is sold by the Sunovion Pharmaceuticals unit of Japanese
drugmaker Dainippon Sumitomo Pharma Co.
The label change decision was made after a study showed Lunesta 3 mg
was associated with severe next-morning psychomotor and memory
impairment in both men and women.
[to top of second column]
The study found that the higher doses can cause
impairment to driving skills, memory and coordination as long as 11
hours after the drug is taken, with little awareness of the
impairment on the part of the patient.
(Reporting by Bill Berkrot; Editing by Dan Grebler)
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