FDA Issues Safety Warning on Lunesta
In mid-May of 2014, the FDA released a warning that eszopiclone (Lunesta) can cause next-day impairment when taken at the recommended target dose of 3 mg/ day. As a result, the FDA has lowered the recommended starting dose to 1 mg/day.
The FDA cites a double blind, placebo controlled study of 91 adults that found working memory and the psychomotor coordination required to drive a car were impaired for up to 11.5 hours after a 3 mg bedtime dose of Lunesta.
They also determined that subjective perception of sedation and coordination—in other words, patients’ abilities to realize they were sleepy or impaired—were no different than placebo, although these patients were actually quite impaired. Women and men were equally affected.
In fact, according to the data summary from the FDA, a 3-mg dose of Lunesta was almost as impairing as 7.5 mg zopiclone, a medication often used as a positive control in studies of driving impairment (and, interestingly, the parent compound of Lunesta).
Doses can be titrated up to 3 mg from the new starting dose of 1 mg, says the FDA, but patients taking the 3 mg dose are cautioned against driving and related activities the next day. Read the warning.
This article originally appeared in The Carlat Psychiatry Report — an unbiased monthly covering all things psychiatry.