May 19, 2014
FDA has recommended labeling changes to lower the initial bedtime dose of eszopiclone (Lunesta) to 1 mg. New information suggests mental alertness may be impaired up to 11 hours or more after receiving a dose of 3 mg. This recommendation is for both men and women who have similar impairment of mental alertness and coordination with the 3 mg dose. A study found that patients were objectively impaired at 11.5 hours, even though their own perception was that they were alert. Subsequent doses may be increased if needed, but the potential for impaired mental alertness is higher with doses exceeding 1 mg.
Healthcare providers should prescribe the lowest effective dose when prescribing any sleep medication. Counsel patients that they may experience impairment from all sleep medications even if they feel fully alert.
Eszopiclone is a sedative-hypnotic used to treat insomnia. The product labeling carries warnings about the risk of drowsiness when taking this medication. FDA has been monitoring the safety profile of this medication since its approval and continues to assess the risk of taking eszopiclone. Additionally, FDA is monitoring and evaluating other insomnia medications for reduced mental-alertness the morning after an administered dose.
Patients should talk to their healthcare provider before making any dosing changes. Report any related adverse events to FDA’s MedWatch Adverse Event Reporting program online: http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm
Additional information is available at the following links:
May 19, 2014; University of Utah, Drug Information Service. Copyright 2014, Drug Information Service, University of Utah, Salt Lake City, UT.