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FDA: Cut Lunesta dosage by 2/3

May 15, 2014
by Pamela Tabar, Editor-in-Chief
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The Food and Drug Administration has reduced its recommended starting dose of  the sleep aid eszopiclone, marketed as Lunesta, from 3 mg to 1 mg, citing excessive impairment the day after taking the medication.

Taking 3 mg doses of the drug can produce functional difficulties and memory problems extending nearly 12 hours later, even though a person may feel fully awake, according to an FDA news release.

Recent clincial studies cited by the FDA associated the 3 mg dose with “severe next-morning psychomotor and memory impairment in both men and women 7.5 hours after taking the drug. The study found that recommended doses can cause impairment to driving skills, memory, and coordination as long as 11 hours after the drug is taken. Despite these long-lasting effects, patients were often unaware they were impaired.” 

The use of sleep aids requires earnest monitoring among older adults, as sleep medications have been connected to increased risk of falls through reduced coordination and balance. In addition, an overly strong dose of a sleep aid can produce symptoms that mimic dementia. Lowering the recommended starting dose to 1 mg should improve mental alertness and motor reactions the next morning, the FDA says.

The FDA urges clincians to amend the doseage immediately for those who are new users of the drug. A similar decision was made for the sleep aid zolpidem, marketed as Ambien, last year.

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