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FDA Reduces Starting Dose of Sleep Drug Lunesta (Eszopiclone)

Treatment carries risk of next-morning impairment

The FDA is requiring Sunovion Pharmaceuticals, manufacturer of the sleep drug Lunesta (eszopiclone), to change the drug’s label and to lower the current recommended starting dose. According to the agency, data show that eszopiclone levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving, even if the patients feel fully awake.

Taken at bedtime, the recommended starting dose of Lunesta has been cut in half — from 2 mg to 1 mg — for both men and women. The 1-mg dose can be increased to 2 mg or 3 mg if needed, but the higher doses are more likely to result in next-day impairment of driving and other activities that require full alertness. Using lower doses means a smaller amount of the drug will remain in the body in the morning hours, the FDA says.

The dose change is partly based on findings from a study of 91 healthy adults aged 25 to 40 years. The study showed that, compared with placebo, Lunesta 3 mg was associated with severe next-morning psychomotor and memory impairment in both men and women 7.5 hours after taking the drug. The study also found that recommended doses can cause impairment to driving skills, memory, and coordination for as long as 11 hours after the drug has been taken. Despite these long-lasting effects, patients were often unaware that they were impaired.

The FDA approved changes to the Lunesta prescribing information and the patient medication guide to include these new prescribing recommendations. The drug labels for generic eszopiclone products must also be updated to include these changes.

In a drug safety communication issued May 15, the FDA urged health care professionals to caution patients taking Lunesta about the risk of next-morning impairment of activities that require mental alertness, including driving. Alertness can be impaired even in people who do not feel drowsy.

Drowsiness is listed as a common side effect for all insomnia drugs, along with warnings that people may still feel drowsy the next day after taking one of these products. The FDA is continuing to evaluate the risk of impaired mental alertness with the entire class of sleep drugs, including over-the-counter products, and will update the public as new information becomes available.

In January 2013, the FDA announced a dose reduction for sleep drugs that contain the active ingredient zolpidem, such as Ambien and Ambien CR (both marketed by Sanofi-Aventis), because of the risk of next-morning impairment.

Source: FDA; May 15, 2014.

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