The insomnia drug Lunesta (eszopiclone) can linger in users’ bloodstreams hours longer than intended, causing impairment of driving and other activities that require alertness, the Food and Drug Administration warned. The agency is recommending that starting doses be lowered to 1 mg at bedtime for both men and women. The drug labels for Lunesta and its generic counterparts will be updated to reflect the new warnings and recommended dosing.
The new dosing is based on a study that found that the previously recommended dose of 3 mg can cause impairment of 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 new recommended starting dose of 1 mg at bedtime will result in less drug in the body the next day, the agency reported.
In January 2013, the FDA issued a Safety Communication involving next-day impairment with the sleep medication Ambien (zolpidem), and recommended that dosages be lowered to reduce the risk. Women were found to be more susceptible to the risk because they eliminate Ambien from their bodies slower than men.
This was not seen to be the case with Lunesta, as the impairment effects were reported in both men and women.
Patients currently taking Lunesta should continue taking their prescribed dose of the drug and contact their doctors about the right dose for them. Doctors are also being advised to start new patients on the 1 mg dose of Lunesa.
The FDA said it is continuing to evaluate the risk of impaired mental alertness with the entire class of sleep aids, including over-the-counter medications available without a prescription. The agency said it will update consumers once its review is complete.