People taking the sleep aid Lunesta® should know the drug can cause impairment of driving and other activities that require mental alertness the morning after use, even if they feel fully awake.
The U.S. Food and Drug Administration (FDA) announced this week that it is requiring Sunovion Pharmaceuticals Inc., maker of the prescription sleep aid Lunesta (eszopiclone), to decrease the recommended starting dose of the drug from 2 mg to 1 mg after study results showed the drug lingered in the body the next day at levels high enough to affect abilities.
“To help ensure patient safety, health care professionals should prescribe, and patients should take, the lowest dose of a sleep medicine that effectively treats their insomnia,” said Ellis Unger, M.D., director, Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research. “Recently, data from clinical trials and other types of studies have become available, which allowed the FDA to better characterize the risk of next-morning impairment with sleep drugs.”
Lunesta is the leading prescription sleep aid, with more than 31 million prescriptions written for the drug.
A study found that impairment to driving skills, memory and coordination can last more than 11 hours after taking a Lunesta dose of 3 mg at bedtime. Despite these driving and other problems, patients were often unaware they were impaired.
The FDA warned in a Safety Announcement that people taking the 3 mg should not drive or engage in other activities that require mental alertness the day after taking Lunesta.
If you are taking 2 mg or 3 mg of Lunesta at bedtime, consult with your doctor regarding these new dosage guidelines. Your doctor can determine the lowest effective dose to reduce risk of adverse effects such as mental impairment the morning after use.
A year ago, the FDA reduced the dosage recommendations of sleep aids containing zolpidem, such as Ambien and Ambien CR, for the same risk of impairment the day after taking the drug.