FDA requires lower starting dose for eszopiclone.
The recommended starting dose for the insomnia drug eszopiclone has been lowered from 2 mg to 1 mg, to address the risk of next-morning impairment associated with the drug, the Food and Drug Administration announced on May 15.
The manufacturer of the drug, marketed as Lunesta, was required to change the starting dose recommendation because of evidence that levels of the drug "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 FDA statement said. The recommendation applies to men and women.
If necessary, the 1-mg dose can be increased to 2 mg or 3 mg, "but the higher doses are more likely to result in next-day impairment of driving and other activities that require full alertness," the statement added.
The FDA also is advising patients who are on the 2-mg or 3-mg doses to contact their health care providers for advice on how they can continue the drug safely, and is cautioning patients on the 3-mg dose not to drive or engage in other activities "that require complete mental alertness the day after use."
The recommendations are based partly on the results of a study of 91 healthy adults aged 24-40 years, which compared the effects of the 3-mg dose of eszopiclone and placebo, according to the FDA. The use of the 3-mg dose was associated with severe psychomotor and memory impairments in men and women the next morning, 7.5 hours after taking the medication. At recommended doses, impairments in driving skills, memory, and coordination were evident for up to 11 hours after the drug was taken, and "despite these long-lasting effects, patients were often unaware they were impaired," the statement said.
In January 2013, the FDA recommended reducing the dose for sleep medications containing zolpidem, which include Ambien and Ambien (CR), for the same reason.
The safety communication regarding this drug is available at www.fda.gov/Drugs/DrugSafety/ucm397260.htm. Serious adverse events associated with this and other insomnia drugs should be reported to the FDA at 800-332-1088 or www.accessdata.fda.gov/scripts/malwatch/