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From Health Law Daily, May 16, 2014

Impaired alertness in patients leads FDA to lower dose of Lunesta

By Susan L. Smith, JD, MA

After the findings of a study showed the a three milligram (mg) dose of the prescription drug Lunesta® (eszopiclone) was associated with severe next-morning psychomotor and memory impairment in both men and women 7.5 hours after taking the drug, the FDA has announced that it required Sunovion Pharmaceuticals Inc., the manufacturer, to lower the current recommended starting dose to 1 mg at bedtime and change the drug label.

The study. Lunesta is used in adults for the treatment of insomnia and sleep problems, with symptoms that include trouble falling asleep and waking up often during the night, according to the manufacturer. An FDA Drug Safety Communication stated that the study showed that “eszopiclone levels of 3 mg can cause impairment to driving skills, memory, and coordination that can last more than 11 hours after receiving an evening dose.” Furthermore, patients were often unaware that they were impaired despite driving and other problems.

FDA changes. The FDA approved changes to Lunesta prescribing information and the patient Medication Guide to include the new recommendations and requires updates to the drug labels for generic eszopiclone products. The FDA has decreased the recommended starting dose from 2 mg to 1 mg for both men and women because “the higher doses are more likely to result in next-day impairment of driving, and other activities that require alertness,” the FDA said.

FDA recommendations. The FDA advised patients currently taking the 2mg and 3mg does of Lunesta to contact their health professional to ask for instructions on how to continue to take the medicine safely. Although the 1 mg dose can be increased to 2 mg or 3 mg, if needed, the FDA warned of the next day impairment to alertness with the higher doses. In addition, the FDA urged health care professionals to caution patients taking Lunesta about the risk of next-morning impairment for activities that require alertness. The FDA is continuing to evaluate the risk of impaired mental alertness with the entire class of sleep drugs, including over-the counter drugs.

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