U.S. health authorities required a change of label for the sleep medication Lunesta to reduce the recommended dosage due to concerns that it impairs alertness in some people the next morning.
This is part of the Food and Drug Administration's effort to reduce the adverse effects of the drug such as drowsiness behind the wheel. The agency is concerned of the problems from sleep medications that do not wear off by the time people drive to work the next morning. For instance, a man from New Jersey was sentenced to over three years in jail because of a fatal head-on collision while being drowsy from Ambien. Former Rep. Patrick Kennedy D-Mass was also charged because of crashing into a barricade while disoriented from prescription medications also including Ambien in 2006.
"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," associate clinical psychiatry professor Dr. Daniel Carlat of Tufts University said. "Lower doses can prevent next-day sleepiness and head off big problems, like car accidents."
The recommended starting dosage of Lunesta or eszopiclone is 2 mg at bedtime for women and men. The agency said that the initial does must be 1 mg but could be increased if the patient needs it. The decision to change the label was made following the association of Lunesta 3 mg with severe memory and psychomotor impairment in women and men. People taking 2 mg and 3 mg doses should consult a doctor about how they should continue the drug. Sunovion Pharmaceuticals of Dainippon Sumitomo Pharma Co. from Japan sells Lunesta.
"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," director of Office of Drug Evaluation, Dr. Ellis Unger in the FDA Center for Drug Evaluation and Research said.
Healthcare services company IMS Health said that around 55 million sleep aid prescriptions were given in the U.S. in 2013. Lunesta accounts for a relatively small share of the market with only around three million tablets prescribed.
