FDA Halves Starting Dose for Lunesta
The U.S. Food and Drug Administration (FDA) has announced that effective immediately the recommended starting dose for the sleep aid Lunesta (eszopicione) will be cut in half.
About the FDA Decision on Lunesta
“Data show that eszopicione levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving, even if they fell fully awake.” – FDA statement as published by Medscape
Medscape reports that the recommended starting dose for Lunesta has been decreased from 2 mg to 1 mg in both men and women.
The decision is based on a study of 91 adults which found that 3 mg of Lunesta was associated with severe pyschomotor and memory impairment in both men and women 7.5 hours after the drug was taken.
The study also found that previous recommended doses could cause impairment to driving skills, memory, and coordination for up to 11 hours after Lunesta was taken; however, despite these effects, patients were often unaware that they were impaired.
While the FDA acknowledges that health care professionals can increase the dose as needed, physicians are urged to prescribe the drug at the minimum dose needed to treat a patient's insomnia.
Other Side Effects of Lunesta
The following adverse events have also been reported to the FDA in patients taken Lunesta:
- Chest pain