FDA issues drug warning on Lunesta
The U.S. Food and Drug Administration (FDA) is warning users of Lunesta, made by Marlborough’s Sunovion Pharmaceuticals, that the insomnia drug can cause next-day impairment of driving and other activities requiring alertness.
The FDA said in a statement that it has decreased the recommended starting dosage of the drug to 1 milligram at bedtime, and that health care professionals should follow those recommendations when starting patients on Lunesta. The FDA said patients already taking the drug should continue their prescribed dose and contact their doctors to ask about the most appropriate dose for them.
According to the FDA, a study found that the previously recommended starting dosage of 3 milligrams can “cause impairment of driving skills, memory and coordination that can last more than 11 hours after receiving an evening dose.” The new recommended dose will result in less drug in the blood the next day.
“We caution patients taking a 3-milligram dose against driving or engaging in other activities that require complete mental alertness the day after use,” the FDA said.
The FDA said it's evaluating the risk of impaired mental alertness in all sleep aid drugs on the market, including over-the-counter drugs, and will issue updates as needed.
Officials at Sunovion could not be reached for comment by deadline Wednesday morning.
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