The U.S. Food and Drug Administration (FDA) is warning that the insomnia drug Lunesta (eszopiclone) can cause next-day impairment of driving and other activities that require alertness.
As a result, the agency has decreased the recommended starting dose of Lunesta to 1 mg at bedtime.
Health care professionals should follow the new dosing recommendations when starting patients on Lunesta, the FDA said.
Patients should continue taking their prescribed dose of Lunesta and contact their health care professionals to ask about the most appropriate dose for them, the FDA said.
A study of Lunesta found that the previously recommended dose of 3 mg can cause impairment to driving skills, memory, and coordination that can last more than 11 hours after receiving an evening dose.
Despite these driving and other problems, patients were often unaware they were impaired, the FDA said.
The new lower recommended starting dose of 1 mg at bedtime will result in less drug in the blood the next day, the FDA said.
Women and men are equally susceptible to impairment from Lunesta, so the recommended starting dose of 1 mg is the same for both.
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, the FDA said.
However, the agency cautioned patients taking a 3 mg dose against driving or engaging in other activities that require complete mental alertness the day after use.
Go to the FDA’s Sleep Disorder (Sedative-Hypnotic) Drug Information Web page to find updated information and access the latest labels for insomnia drugs.