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FDA orders lower starting dose for Lunesta

The U.S. Food and Drug Administration has ordered the manufacturer of the sleep drug Lunesta (eszopiclone) to change the drug label and lower the current recommended dose from 2mg to1 mg for both men and women, although doctors may increase it up to 3mg if necessary. However, the agency warns that the "higher doses are more likely to result in next-day impairment of driving and other activities that require full alertness even if they feel fully awake." The pills are taken at bedtime.

“The new measure is meant 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,” stated Ellis Unger, M.D., director, Office of Drug Evaluation I in the FDA's Center for Drug Evaluation and Research.

The change comes after a recent study of 91 healthy adults 25-40 years old showed that Lunesta 3 mg was connected to "severe next-morning psychomotor and memory impairment in both men and women 7.5 hours after taking the drug." The study also found that recommended doses can cause impairment to driving skills, memory, and coordination as long as 11 hours after the drug is taken, although many of the patients did not realize it. Using lower doses means less drug will remain in the body in the morning hours."

For more information, consumers can contact the FDA at 888 Info-FDA