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FDA: Start Sleep Medication Lunesta at Lower Dose for Safety

Agency points to studies showing daytime drowsiness that could interfere with driving

THURSDAY, May 15, 2014 (HealthDay News) -- The recommended starting dose of Lunesta (eszopiclone) has been lowered due to studies showing that levels of the medication, in some patients, can remain high enough in the morning to interfere with driving and other activities that require mental alertness, the U.S. Food and Drug Administration said on Thursday. This impairment can occur even if patients feel fully awake, the FDA said.

The recommended starting dose of Lunesta -- taken at bedtime -- has been reduced from 2 mg to 1 mg for both women and men. The dose can be increased to 2 mg or 3 mg if needed, but those higher doses are more likely to reduce alertness the next morning, the FDA noted. The agency advised that patients who are currently taking 2-mg or 3-mg doses of Lunesta discuss the issue with their doctor, deciding on how to keep taking the drug safely and at a dose that best suits them.

One of the studies cited by the FDA included 91 healthy adults, aged 25 to 40. It found that currently recommended doses of Lunesta could hamper driving skills, memory, and coordination for as long as 11 hours after taking the drug. Despite these effects, patients often did not realize they were impaired.

"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, M.D., director of the Office of Drug Evaluation I in the FDA's Center for Drug Evaluation and Research, said in the FDA news release.

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