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May 29, 2014
FDA Reduces Eszopiclone Starting Dose to Reduce
Next-Day Impairment Washington, DC—Warning that the insomnia drug eszopiclone can cause next-day impairment of driving and other activities requiring alertness, the FDA has reduced the recommended starting dose to 1 mg at bedtime. The previously recommended dose of 3 mg can cause impairment to driving skills, memory, and coordination that can last more than 11 hours after receiving an evening dose, according to a safety alert which pointed out that patients often are unaware they are impaired. With the lower recommended starting dose of 1 mg at bedtime, less drug will remain in patients’ systems the next day, the FDA said. The FDA advised patients to continue taking their prescribed dose of eszopiclone, marketed as Lunesta, but to contact the prescriber to ask about the most appropriate dose for them. Health care professionals, meanwhile, are requested to follow the new dosing recommendations for both men and women, who are equally susceptible to the effects, when starting patients on the sleep aid. The 1 mg dose can be increased to 2 mg or 3 mg if needed, according to the FDA communication, but the higher doses are more likely to result in next-day impairment of driving and other activities that require full alertness. “We caution patients taking a 3 mg dose against driving or engaging in other activities that require complete mental alertness the day after use,” the regulators said. The new recommendations are included in changes to the Lunesta prescribing information and the patient Medication Guide. Drug labels for generic eszopiclone products also will also be updated. The action was based on a double-blind study of 91 healthy adults between 25 and 40 years old who had the effects of Lunesta 3 mg on psychomotor function assessed the following morning, between 7.5 and 11.5 hours after dosing. Based on tests of psychomotor coordination that are correlated with the ability to maintain a motor vehicle in the driving lane, tests of working memory, and subjective perception of sedation and coordination, Lunesta 3 mg was associated with next-morning psychomotor and memory impairment compared to placebo. Impairment was most severe at 7.5 hours but still present and potentially clinically meaningful at 11.5 hours, according to the FDA. In addition, subjective perception of sedation and coordination from Lunesta 3 mg was not significantly different from placebo, even though the subjects were objectively impaired. In fact, Lunesta 3 mg had an impairing effect almost as large as zopiclone 7.5 mg, a similar insomnia drug, according to the study. Zopiclone, which is not approved in the United States, causes consistent psychomotor impairment and is often used as a positive control in driving impairment studies, according to the FDA. Last year, the FDA recommended that the bedtime dose of zolpidem, marketed as generics and under the brand names Ambien, Ambien CR, Edluar, and Zolpimist be lowered because new data show that blood levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving.
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U.S. Pharmacist Social Connect
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