US FDA calls for lower starting dose for sleep drug Lunesta

The US Food and Drug Administration says it has required the manufacturer of the sleep drug Lunesta (eszopiclone) to change the drug label and lower the current recommended starting dose. The drug is sold by Sunovion Pharmaceuticals, a US subsidiary of Japanese drug major Dainippon Sumitomo Pharma (TYO: 4506).

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 they feel fully awake, the agency said. In January 2013, the FDA announced a dose reduction for sleep drugs that contain the active ingredient zolpidem, such as Ambien and Ambien CR, because of the risk of next morning impairment.

Half of current dosage recommended

Taken at bedtime, the recommended starting dose of Lunesta (eszopiclone) has been decreased from 2mg to 1mg for both men and women. The 1mg dose can be increased to 2mg or 3mg 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 less drug will remain in the body in the morning hours.

“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,” said Ellis Unger, director, Office of Drug Evaluation I in the FDA's Center for Drug Evaluation and Research. “Recently, data from clinical trials and other types of studies have become available, which allowed the FDA to better characterize the risk of next-morning impairment with sleep drugs.”

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 3mg 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 FDA today approved changes to the Lunesta prescribing information (label) 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.