SILVER SPRING, Md. -- Patients starting on the sleep drug eszopiclone (Lunesta) should take no more than 1 mg at bedtime -- one-third the current label-recommended dose -- because of the risk of next-day impairment, the FDA said Thursday.
The move follows a similar reduction last year in recommended dosing for another popular prescription sleep aid, zolpidem (Ambien).
FDA officials after reviewing results from a 91-person, placebo-controlled study in which participants taking the drug at 3 mg showed significantly impaired psychomotor and memory function up to 11.5 hours later, compared with the placebo group.
These functional impairments were "most severe at 7.5 hours but still present and potentially clinically meaningful at 11.5 hours," the FDA said in a statement.
It added that there were no significant differences between treatments in participants' self-assessments of sedation and coordination -- suggesting that those with actual impairments may not have been aware of them.
The FDA said the new 1-mg starting dose applies to men as well as women.
Doses "can be increased to 2 mg or 3 mg if needed, but the higher doses are more likely to result in next-day impairment of driving and other activities that require full alertness," the agency indicated.
"We caution patients taking a 3-mg dose against driving or engaging in other activities that require complete mental alertness the day after use."
The new recommended starting dose will be incorporated into a revised label and patient Medication Guide for eszopiclone, the FDA said. It urged healthcare professionals to adopt the recommendations immediately for patients starting on the drug.
Eszopiclone is currently available in 1-, 2-, and 3-mg pills. The drug is marketed by Sunovion Pharmaceuticals.