New Dosing for Lunesta Cuts Next-day "Hangover" Effect

Recommended starting dose of the sleep aid Lunesta (eszopiclone) is now 1 mg, and reflects new findings that higher doses cause "hangover" effect—impaired large motor skills and memory.  Unlike similar action taken to reduce medication side effects of Ambien, the dosage reduction is recommended in both men and women with insomnia.

Following reports of a "hangover" effect—memory loss, lack of coordination, and impaired driving skills—after taking Lunesta (eszopiclone), the Food and Drug Administration (FDA) requested the manufacturer of the sleep aid  to change the drug label and lower the current recommended starting dose.

According to the FDA, "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."

Taken at bedtime, the recommended starting dose of Lunesta "has been decreased from 2 mg to 1 mg for both men and women" to reduce medication side effects. "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 less drug will remain in the body in the morning hours," noted the agency in a safety alert sent to doctors.

“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, MD, 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.”

Why the Dosage Change

The FDA took action following the results of a post-marketing study.  The study showed that when people took 3 mg of Lunesta,  the next-morning they had "severe psychomotor and memory impairment in both men and women 7.5 hours after taking the drug." The researchers who conducted the study said that 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.

This dosage reduction comes after similar action by the FDA in January 2013, when it requested dose reduction for products containing the popular sleep aid zolpidem (Ambien and Ambien CR). In that case, however, next-day impairment was found only in women taking the recommended dose. The FDA recommended that manufacturers lower the dose of Ambien by half in women. 

Pain and Sleep

Many patients with acute and chronic pain have trouble failing asleep and, once asleep, staying asleep. The more pain, the more sleep disturbances, and vice versa. Therefore, many doctors treating patients with chronic pain will evaluate the patient for signs and symptoms of insomnia: patient's daytime function, overall health, and sleep quality. The next step is to eliminate any habits (like caffeine intake, watching TV in bed, frequent napping) or medications (certain medication can cause insomnia) that may be causing sleep problems.  

The main goals of treating insomnia include improving sleep time and quality and reducing daytime impairment. If your doctor recommends a sleep aid or medication, be aware that daytime 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 drugs, and will update the public as new information becomes available," noted the press release.

What Patients Should Do

Patients currently taking the 2 mg and 3 mg doses of Lunesta should contact their health care professional to ask for instructions on how to continue to take their medicine safely at a dose that is best for them.

Updated on: 05/19/14