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FDA halves Lunesta starting dose


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Who would have thought that taking a certain nighttime dose of a popular sleeping pill and driving the next morning do not necessarily mix?

The inference stems from the action the U.S. Food and Drug Administration took in May. The regulatory agency essentially ordered that the recommended starting dose of the sleep drug Lunesta (eszopiclone) be halved because of concerns about the drug’s morning-after side effects. The FDA also called for an accompanying labeling change.

A study showed that certain levels of eszopiclone in some patients may be high enough in the morning to impair driving and other activities that require alertness – even if they feel alert.

Hence, per the FDA, the recommended starting dose of Lunesta has been decreased from 2 milligrams to 1 milligram. The key words here are “recommended starting dose.” The starting dose can be increased up to 3 milligrams, but the higher doses are more likely to lead to impairment of driving and of other activities that require alertness the following morning, according to the FDA.

The FDA recommends that patients taking 2 milligrams or more of Lunesta contact their health care professionals for instructions on how to proceed.

The FDA characterized the figures behind the facts as follows: “The dose change is based, in part, on findings from a study of 91 healthy adults ages 25 to 40. The study shows, compared to an inactive pill (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 found that recommended doses can cause impairment to driving skills, memory, and coordination as long as 11 hours after the drug is taken. Despite these long-lasting effects, patients were often unaware they were impaired.”

The way Lipitor is linked to diabetes and the way Zoloft is tied to birth defects, time will tell whether Lunesta patients who were injured as a result of morning-after impairment will be entitled to compensation. Nevertheless, anyone who has been injured because of what may have been an unreasonable risk posed by a medication should get a free consultation from one of the experienced product liability attorneys at Reich & Binstock.

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