US lowers Lunesta dose due to next-day drowsiness

May 15, 2014 by Matthew Perrone

U.S. health officials are lowering the starting dose of the popular sleeping aid drug Lunesta, due to risks of morning drowsiness that can impair driving ability and lead to injury.

The Food and Drug Administration said Thursday it is taking action based on a study that found Lunesta users had problems with driving, memory and coordination up to 11 hours after first taking the . Patients are often unaware that they are still drowsy the morning after, according to the FDA, which monitors food and drugs for safety.

The results, published last month, compared 91 taking Lunesta or placebo while performing several tasks measuring coordination, memory and other cognitive measures.

Lunesta manufacturer Sunovion Pharmaceuticals, a subsidiary of Japanese drugmaker Dainippon Sumitomo Pharma, will lower the starting dose of the tablet to 1 milligram from currently available 2 milligrams. Patients can increase their dose to 2 or 3 milligrams, but should keep in mind that higher doses are more likely to cause next-day impairment, according to the FDA statement.

Patients currently taking 2 or 3 milligram doses of Lunesta should contact their doctor to get information about the most appropriate dose.

Drowsiness is a side effect listed on the labels of all anti-insomnia drugs, the agency release notes.

Thursday's announcement follows a similar FDA action last year that reduced the dosage of Ambien and other generic insomnia drugs containing the ingredient zolpidem. Those drugs are the most widely prescribed sleep aids in the U.S. Lunesta uses a different active ingredient called eszopiclone.

"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 FDA's Dr. Ellis Unger said in a statement.

Lunesta, launched in 2005, is designed to be taken before bed to help patients with insomnia fall asleep and stay asleep for up to 7 hours.

Calls to Sunovion Pharmaceuticals Inc. were not immediately returned Thursday afternoon.

Explore further: FDA: lower ambien's dose to prevent drowsy driving

Related Stories

FDA: lower ambien's dose to prevent drowsy driving

May 15, 2013
(HealthDay)—The U.S. Food and Drug Administration has approved new, lower-dose labeling for the popular sleep drug Ambien (zolpidem) in an effort to cut down on daytime drowsiness that could be a hazard while performing ...

FDA requires lower doses for sleep medications (Update)

January 10, 2013
(HealthDay)—The U.S. Food and Drug Administration announced Thursday that it is asking manufacturers of sleep medications containing zolpidem—including Ambien—to lower the recommended doses and to provide more safety ...

Is a better sleeping pill on the way?

April 3, 2013
(HealthDay)—A new class of sleep medications appears to help people fall asleep without causing grogginess the next day, researchers say.

FDA has safety concerns on Merck insomnia drug

May 20, 2013
Federal health regulators say an experimental insomnia drug from Merck can help patients fall asleep, but it also carries worrisome side effects, including daytime drowsiness and suicidal thinking.

US approves drug for middle-of-the-night insomniacs

November 23, 2011
The US Food and Drug Administration, for the first time, approved Wednesday medication specifically designed for those who wake up in the middle of the night and cannot fall back to sleep.

Merck: FDA wants more studies of insomnia drug

July 1, 2013
Drugmaker Merck & Co. says federal regulators have ruled that they won't approve high doses of its experimental insomnia medication because of concerns about their safety.

Recommended for you

In most surgery patients, length of opioid prescription, number of refills spell highest risk for misuse

January 17, 2018
The possible link between physicians' opioid prescription patterns and subsequent abuse has occupied the attention of a nation in the throes of an opioid crisis looking for ways to stem what experts have dubbed an epidemic. ...

Patients receive most opioids at the doctor's office, not the ER

January 16, 2018
Around the country, state legislatures and hospitals have tightened emergency room prescribing guidelines for opioids to curb the addiction epidemic, but a new USC study shows that approach diverts attention from the main ...

FDA bans use of opioid-containing cough meds by kids

January 12, 2018
(HealthDay)—Trying to put a dent in the ongoing opioid addiction crisis, the U.S. Food and Drug Administration on Thursday slapped strict new restrictions on the use of opioid-containing cold and cough products by kids.

Taking ibuprofen for long periods found to alter human testicular physiology

January 9, 2018
A team of researchers from Denmark and France has found that taking regular doses of the pain reliever ibuprofen over a long period of time can lead to a disorder in men called compensated hypogonadism. In their paper published ...

Nearly one-third of Canadians have used opioids: study

January 9, 2018
Nearly one in three Canadians (29 percent) have used "some form of opioids" in the past five years, according to data released Tuesday as widespread fentanyl overdoses continue to kill.

Growing opioid epidemic forcing more children into foster care

January 8, 2018
The opioid epidemic has become so severe it's considered a national public health emergency. Addiction to prescription painkillers, such as oxycodone and morphine, has contributed to a dramatic rise in overdose deaths and ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.