Starting dose for eszopiclone lowered to 1 mg

Eszopiclone (Lunesta) can cause next-day impairment of driving and other activities and therefore should be started at a dose of 1 mg, the FDA warned last week.

The change was based on a study of 91 healthy adults between 25 and 40 years old who took the previously recommended dose of 3 mg and had their psychomotor function assessed the following morning. The drug was associated with psychomotor and memory impairment that was most severe at 7.5 hours after dosing but still present and potentially clinically meaningful at 11.5 hours. Subjective perception of sedation and coordination was not consistently different from placebo, even though the subjects were objectively impaired.

Women and men are equally susceptible to impairment, so the recommended starting dose of 1 mg is the same for both, the FDA statement said. The 1-mg dose 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. Clinicians should caution patients taking a 3-mg dose against engaging in such activities the day after use.

The FDA is continuing to evaluate the risk of impaired mental alertness with the entire class of sleep aid drugs, including over-the-counter drugs available without a prescription, and will update the public as new information becomes available.