The federal agency ordered the manufacturer, Sunovion Pharmaceuticals, to change its warning labels to reflect the new FDA recommendations, which are a scale-back of the current 2 milligram dose, The New York Times reported.
The warning comes after studies showed that users still had high doses of the drug in their systems when they awoke, and as they prepared to go out the doors to their morning commutes and drives.
And it’s not the first time the FDA has called for backed-off dosages of sleeping medications. In January 2013, the agency called for the halving of recommended does of Ambien for women and suggested the manufacturer might want to consider the same for men, The Times said.
With Lunesta, the FDA wants dosage levels lowered for both men and women.
“The FDA is looking at the data as it comes out and making sure we understand that many sleeping pills are not as benign as we assume,” said Daniel Carlat, an associate clinical professor of psychiatry at Tufts University. “Lower doses can prevent next-day sleepiness and head off big problems, like car accidents.”
The FDA’s latest recommendation comes in part from research that involved 91 adults at the Surrey Clinical Research Center in Britain. The study found that 3 milligrams of Lunesa impairs memory and motor skills the next day and that the recommended 2 milligrams could prove a challenge for driving, memory and fine-motor skills for up to 11 hours after ingesting.
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