FDA Requires Lower Lunesta Starting Dose

The agency has announced it will be requiring a lower starting dose for the sleep drug

The FDA has announced it will be requiring the manufacturer of Lunesta (eszopiclone), a sleep drug, to lower the current recommended starting dose on the drug’s label. According to a report from the FDA, data has shown that eszopiclone levels in some patients may be high enough the morning after use that they could impair activities that require alertness. Patients may feel fully awake but actually be impaired.

The recommended dose has been lowered from 2 mg to 1 mg for both men and women. The drug’s dose can be increased to 2 or 3 mg, though a higher dose is more likely to result in next day impairment. The change in dose comes as a result of a recent study that followed 91 healthy adults ages 25-40. The study showed that Lunesta 3 mg, when compared to a placebo pill, was associated with “severe next-morning psychomotor and memory impairment in both men and women 7.5 hours after taking the drug.”

“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,” said Ellis Unger, M.D., director, Office of Drug Evaluation I in the FDA's Center for Drug Evaluation and Research, in the FDA’s press release. “Recently, data from clinical trials and other types of studies have become available, which allowed the FDA to better characterize the risk of next-morning impairment with sleep drugs.”

Current Lunesta users taking 2 or 3 mg should consult their health care professional for next step instructions. 

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  • OHS Magazine Digital Edition - June 2022

    June 2022

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