logo
  Join        Login             Stock Quote

FDA Requires Lower Recommended Doses For Zolpidem-Containing Sleep Drugs

 January 10, 2013 10:56 AM


(By Balachander) The U.S. Food and Drug Administration (FDA) has recommended lower doses for certain sleep drugs containing zolpidem, a sedative-hypnotic (sleep) medicine that is used in adults to treat insomnia.

The FDA said it is requiring the manufacturers of certain zolpidem-containing products to revise their dosing recommendations because new data show that blood levels in some patients may be high enough the morning after use to impair activities that require alertness.

Using lower doses of zolpidem means less of the drug will remain in the blood in the morning hours. Since women eliminate zolpidem from their bodies more slowly than men, the FDA said it has notified the manufacturers that the recommended dose should be lowered for women and that the labeling should recommend that health care professionals consider a lower dose for men.

[Related -Pfizer Inc. (PFE) Q2 Earnings Preview: A Penny Here a Penny There]

Zolpidem products approved for bedtime use are marketed as generics and under the brand names Ambien, Ambien CR, Edluar, and Zolpimist.

The FDA has informed the manufacturers that the recommended dose of zolpidem for women should be lowered from 10 mg to 5 mg for immediate-release products (Ambien, Edluar, and Zolpimist) and from 12.5 mg to 6.25 mg for extended-release products (Ambien CR).

For men, the labeling should recommend that health care professionals consider prescribing the lower doses 5 mg for immediate-release products and 6.25 mg for extended-release products.

The FDA said data from clinical trials and driving simulation studies allowed it to better characterize the risk of driving impairment caused by specific blood levels of zolpidem and to recognize the increased risk of driving-impairing blood levels of zolpidem in women.

[Related -AbbVie Inc. (ABBV): Headed $67’s Way – Maybe More]

This led FDA to require the manufacturers of certain zolpidem-containing products to revise the dosing recommendations, it said.

The U.S. health regulator said it is continuing to evaluate the risk of impaired mental alertness with other insomnia drugs, including over-the-counter (OTC) drugs available without a prescription.

iOnTheMarket Premium
Advertisement

Advertisement


Post Comment -- Login is required to post message
Name:  
Alert for new comments:
Your email:
Your Website:
Title:
Comments:
 

rss feed

Latest Stories

article imageFord Motor Company (F) Q2 Earnings Preview: Light on the Top Line?

Ford Motor Company (NYSE:F) will release its preliminary second quarter 2014 results at 6:30 a.m. EDT read on...

article imageTripadvisor Inc. (TRIP) Q2 Earnings Preview: On Target Enough?

Tripadvisor Inc. (NASDAQ:TRIP) will release its second quarter financial results after market close on read on...

article imageFacebook Inc. (FB) Q2 Earnings Preview: Scoring Big on the World Cup

Facebook Inc. (NASDAQ:FB) will post its second-quarter 2014 financial results after the market close on read on...

article imageThe Boeing Company (BA) Q2 Earnings Preview: Durable Earnings Beater

The Boeing Company (NYSE:BA) will publish its second-quarter financial results before the open of the read on...

Advertisement
Popular Articles

Advertisement
Daily Sector Scan
Partner Center



Fundamental data is provided by Zacks Investment Research, and Commentary, news and Press Releases provided by YellowBrix and Quotemedia.
All information provided "as is" for informational purposes only, not intended for trading purposes or advice. iStockAnalyst.com is not an investment adviser and does not provide, endorse or review any information or data contained herein.
The blog articles are opinions by respective blogger. By using this site you are agreeing to terms and conditions posted on respective bloggers' website.
The postings/comments on the site may or may not be from reliable sources. Neither iStockAnalyst nor any of its independent providers is liable for any informational errors, incompleteness, or delays, or for any actions taken in reliance on information contained herein. You are solely responsible for the investment decisions made by you and the consequences resulting therefrom. By accessing the iStockAnalyst.com site, you agree not to redistribute the information found therein.
The sector scan is based on 15-30 minutes delayed data. The Pattern scan is based on EOD data.