FDA: Start sleep drug lunesta at lower dose for safety - KFVS12 News & Weather Cape Girardeau, Carbondale, Poplar Bluff

FDA: Start sleep drug lunesta at lower dose for safety

© iStockphoto.com / Jacob Wackerhausen © iStockphoto.com / Jacob Wackerhausen
  • SPONSORED BY SOUTHEAST HEALTHMore>>

  • New technology connects babies and families with webcams

    New technology connects babies and families with webcams

    New technology connects babies and families with webcams

    Thursday, July 31 2014 7:45 PM EDT2014-07-31 23:45:11 GMT
    The Heartland is now home to the newest cutting edge technology for moms and babies facing long hospitals stays when the little ones need special intensive care.
    The Heartland is now home to the newest cutting edge technology for moms and babies facing long hospitals stays when the little ones need special intensive care. 
  • Quinn signs epinephrine law for Illinois schools

    Quinn signs epinephrine law for Illinois schools

    Wednesday, July 30 2014 6:36 PM EDT2014-07-30 22:36:36 GMT
    A new bill signed into Illinois law says trained personnel at schools statewide will be able to administer injectable epinephrine for those appearing to have strong allergic reactions.
    A new bill signed into Illinois law says trained personnel at schools statewide will be able to administer injectable epinephrine for those appearing to have strong allergic reactions.
  • Illinois Medicaid restricts use of hepatitis drug

    Illinois Medicaid restricts use of hepatitis drug

    Wednesday, July 30 2014 2:41 PM EDT2014-07-30 18:41:49 GMT
    Illinois is placing tight restrictions on a new hepatitis C drug that costs $1,000 per pill. Medicaid patients must meet 25 criteria and get prior approval before the government health care program will pay for...
    Illinois is placing tight restrictions on a new hepatitis C drug that costs $1,000 per pill. Medicaid patients must meet 25 criteria and get prior approval before the government health care program will pay for Sovaldi.

THURSDAY, May 15, 2014 (HealthDay News) -- Some users of the popular sleep medicine Lunesta remain too drowsy for safety during the day, and the recommended starting dose for the medicine should be lowered, the U.S. Food and Drug Administration said on May 15.

In a statement, the agency said it took the action due to studies showing that levels of Lunesta (eszopiclone) in some patients may remain high enough in the morning to interfere with driving and other activities that require them to be mentally alert.

This impairment can occur even if patients feel fully awake, 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," Dr. Ellis Unger, director of the Office of Drug Evaluation I in the FDA's Center for Drug Evaluation and Research, said in the FDA news release.

The recommended starting dose of Lunesta -- taken at bedtime -- has been reduced from 2 milligrams (mg) to 1 mg for both women and men, which means that less of the drug will remain in the body the next morning.

The dose can be increased to 2 mg or 3 mg if needed, but those higher doses are more likely to reduce alertness the next morning, the FDA noted.

The agency advised that patients who are currently taking 2-mg or 3-mg doses of Lunesta discuss the issue with their doctor, deciding on how to keep taking the drug safely and at a dose that best suits them.

One of the studies cited by the FDA included 91 healthy adults, aged 25 to 40. It found that currently recommended doses of Lunesta could hamper driving skills, memory and coordination for as long as 11 hours after taking the drug. Despite these effects, patients often did not realize they were impaired.

Prescribing information on Lunesta's label will be changed, and the same changes must be made to the labels of generic versions of eszopiclone, the FDA said. The agency also wants doctors to caution patients taking Lunesta about the risk of impaired alertness the next morning.

Next-day drowsiness is a common side effect of all insomnia drugs, the FDA noted.

In 2013, the agency ordered a dose reduction for sleep drugs with the active ingredient zolpidem, such as Ambien and Ambien CR.

More information

The U.S. National Library of Medicine has more about insomnia.

Copyright © 2014 HealthDay. All rights reserved.

*DISCLAIMER*: The information contained in or provided through this site section is intended for general consumer understanding and education only and is not intended to be and is not a substitute for professional advice. Use of this site section and any information contained on or provided through this site section is at your own risk and any information contained on or provided through this site section is provided on an "as is" basis without any representations or warranties.
Powered by WorldNow

310 Broadway
Cape Girardeau, MO 63701

FCC Public File
publicfile@kfvs12.com
573-335-1212
EEO Report
Closed Captioning

All content © Copyright 2000 - 2014 Worldnow and KFVS12. All Rights Reserved.
For more information on this site, please read our Privacy Policy and Terms of Service.