FDA lowers starting dose for sleeping aid Lunesta - Dallas News | myFOXdfw.com

FDA lowers starting dose for sleeping aid Lunesta

Posted: Updated:

By MATTHEW PERRONE AP Health Writer

WASHINGTON (AP) -- 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 drug. 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 patients 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.

Copyright 2014 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

  • HealthMore>>

  • Aire Ancient Baths

    A relaxing bathhouse in busy Tribeca

    A relaxing bathhouse in busy Tribeca

    Tuesday, July 29 2014 10:29 PM EDT2014-07-30 02:29:51 GMT
    Deep beneath the hustle and bustle of Tribeca lies a modern-day oasis brimming with old world charm: Aire Ancient Baths, my new favorite city escape. The breathtaking spa is illuminated by hundreds of candles and smells of invigorating eucalyptus. For around $80 you can bathe in the tranquil blue pools for 90 minutes and find the temperature that's right for you.
    Deep beneath the hustle and bustle of Tribeca lies a modern-day oasis brimming with old world charm: Aire Ancient Baths, my new favorite city escape. The breathtaking spa is illuminated by hundreds of candles and smells of invigorating eucalyptus. For around $80 you can bathe in the tranquil blue pools for 90 minutes and find the temperature that's right for you.
  • NY brothers invent machine that makes CPR easier

    NY brothers invent machine that makes CPR easier

    Tuesday, July 29 2014 6:40 PM EDT2014-07-29 22:40:57 GMT
    Only 10 percent of people who get CPR from a bystander actually survive. But two young men in Westchester County have now patented a device that could dramatically increase those odds and save lives. John and Chris DiCapua's sitting room in their parents' Westchester County home has had a unique guest lying around for quite a while now: a CPR dummy. What began as an idea from their time as Boy Scouts is now a device that could potentially save lives.
    Only 10 percent of people who get CPR from a bystander actually survive. But two young men in Westchester County have now patented a device that could dramatically increase those odds and save lives. John and Chris DiCapua's sitting room in their parents' Westchester County home has had a unique guest lying around for quite a while now: a CPR dummy. What began as an idea from their time as Boy Scouts is now a device that could potentially save lives.
  • 'Fist bump' may beat handshake for cleanliness

    'Fist bump' may beat handshake for cleanliness

    British researchers report that an alternative to the traditional handshake might spread far fewer germs around.
    British researchers report that an alternative to the traditional handshake might spread far fewer germs around.
Powered by WorldNow

KDFW FOX 4
400 N. Griffin Street
Dallas, Texas 75202

Main Station Directory:
(214) 720-4444
News Fax:
(214) 720-3263 or (214) 720-3333

Didn't find what you were looking for?
All content © Copyright 2000 - 2014 Fox Television Stations, Inc. and Worldnow. All Rights Reserved.
Privacy Policy | Terms of Service | Ad Choices