FDA Cuts Starting Dose of Eszopiclone (Lunesta) in Half

Megan Brooks

Disclosures

May 15, 2014

The US Food and Drug Administration (FDA) has lowered the recommended starting dose of the sleep aid eszopiclone (Lunesta, Sunovion Pharmaceuticals Inc) effective immediately, the agency announced today.

"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 FDA said in a statement.

The agency decreased the recommended starting dose of eszopiclone 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," the FDA said.

"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," Ellis Unger, MD, director, Office of Drug Evaluation in the FDA's Center for Drug Evaluation and Research, said in the statement.

"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," Dr. Unger added.

The dose decrease is based, in part, on a study of 91 healthy adults aged 25 to 40 years. The study found that eszopiclone, 3 mg, was associated with severe next-morning psychomotor and memory impairment in both men and women 7.5 hours after they took the drug, compared with placebo.

"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 said.

The Lunesta prescribing information (label) and patient Medication Guide will reflect the new recommended starting dose. The drug labels for generic eszopiclone products will also be updated to include these changes.

In a drug safety communication, the FDA urges healthcare professionals to caution patients taking eszopiclone about the risk for next-morning impairment for activities that require mental alertness, including driving. Alertness can be impaired even in people who do not feel drowsy. 

"The FDA is continuing to evaluate the risk of impaired mental alertness with the entire class of sleep drugs, including over-the-counter drugs, and will update the public as new information becomes available," 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 for next-morning impairment, as reported by Medscape Medical News.

Adverse reactions or quality problems experienced with these products should be reported to MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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