Navigation Links
FDA: Lower Ambien's Dose to Prevent Drowsy Driving
Date:1/11/2013

By Amanda Gardner
HealthDay Reporter

THURSDAY, Jan. 10 (HealthDay News) -- 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 information to patients.

These sleep medications include Ambien, Ambien CR, Edluar and Zolpimist, as well as generic versions of Ambien and Ambien CR.

Officials are concerned that blood levels of zolpidem are high enough the morning after taking the drugs to continue to impair one's ability to perform certain activities.

"The purpose of the lowering is to help decrease the risk of next-morning impairment of activities that require alertness," said Dr. Ellis Unger, director of the Office of Drug Evaluation I at the FDA's Center for Drug Evaluation and Research. "We're particularly concerned about driving. A large fraction of the population drives and driving is an inherently dangerous activity."

Lowering the nighttime dose means there will be less residual drug in the blood by the time the person wakes up. Extended-release forms of the drugs tend to stay in the body longer.

The FDA has told manufacturers that recommended doses for women should be cut in half, from 10 milligrams to 5 milligrams 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 agency has asked manufacturers to change the labeling to recommend that doctors and other health-care professionals consider prescribing lower doses, meaning 5 mg for immediate-release products and 6.25 mg for extended-release products.

In explaining the different recommendations for men and women, Unger said at a midday news conference that "women appear to be more susceptible to risk for next-morning impairment because they eliminate zolpidem from their bodies more slowly."

It's not clear why women eliminate the substance from their bodies more slowly than men.

Although there have been reports of adverse events, including motor vehicle accidents possibly related to zolpidem, the link has not and probably cannot be definitely established, Unger said.

The changes were spurred by new driving-simulation studies showing that currently prescribed levels of drugs containing zolpidem may be high enough to impair alertness the next day, he explained.

The FDA will be requiring driving-simulation studies for new sleep medications, and it is assessing other insomnia medications on the market. Eventually, Unger said, "we want driving data on all sleep medications."

Unger emphasized that next-day impairment is not limited to medications containing zolpidem but to all sleep medications.

"For all sleep medications, doctors should prescribe and patients should take the lowest dose," he said.

People taking any kind of sleep medication should not change their dose without first talking to their health-care professional, he stressed.

More information

Visit the U.S. Food and Drug Administration for more about next-morning impairment.

SOURCE: Jan. 10, 2013, news conference with Ellis Unger, M.D., director, Office of Drug Evaluation I, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration


'/>"/>
Copyright©2012 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. Reductions in Wood-Burning Stoves Tied to Lower Death Rates
2. Corporate Whistle Blower Center Now Urges Physicians Medical Device and Drug Industry Insiders To Step Up-If They Have Proof Of Serious Wrongdoing or Overbilling
3. Common Blood Pressure Drugs Might Lower Dementia Risk
4. Low Vitamin D in Early Pregnancy Tied to Lower Birth Weight
5. Corporate Whistle Blower Center Now Urges Physicians to Become a Whistleblower if They Have Proof a Medical Device or a Drug Product was Defective-and it was Sold Anyway
6. Corporate Whistle Blower Center Now Urges Physicians, Medical Device or Drug Insiders With Proof A Company Knowingly Sold A Bad Product to Become a Whistleblower
7. Astro Clairvoyant Norah Guide with Premium Astrology Helps Friends and Followers Predict and Understand Current Events At No Cost
8. New Diabetes Guidelines May Lower Patient Medical Bills
9. Patients with diabetes may not receive best treatment to lower heart disease risk
10. Corporate Whistle Blower Center Now Urges Medical Industry Insiders to Blow the Whistle if They Can Prove a Medical Product was Defective and Their Company Sold it Anyway
11. EPA Lowers Permissible Soot Levels in Air
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA: Lower Ambien's Dose to Prevent Drowsy Driving
(Date:6/20/2017)... ... 20, 2017 , ... United Benefit Advisors (UBA), the nation’s ... (pronounced you-bee) for 2017. The award honors Partner Firms, Principals, agency staff, ... the clients they serve, and the benefits insurance industry as a whole. , ...
(Date:6/20/2017)... ... June 20, 2017 , ... Caduceus International Publishing ... to announce a new online course entitled Personal & Community Health ... evidence-based strategies for achieving optimal well-being and teaches students how to apply them ...
(Date:6/20/2017)... , ... June 20, 2017 , ... Fresenius Vascular Care, ... minimally invasive techniques to treat and manage a wide range of vascular conditions, has ... initiative. With more than 65 centers represented by more than 40 local brands, a ...
(Date:6/20/2017)... ... 20, 2017 , ... EdChoice and the American Enterprise Institute ... promote economic development in economically distressed urban areas. The first report presents a ... to the economic development of the city of Santa Ana, California. The second ...
(Date:6/20/2017)... New York, NY (PRWEB) , ... June 20, 2017 , ... ... announced today their continued expansion and success in the clinical trials market. Similar to ... building a track record in the clinical trials marketplace by proving the value of ...
Breaking Medicine News(10 mins):
(Date:6/16/2017)... 50 years ago today, the Monterey Pop Festival opened its ... San Francisco "Summer of Love."  To celebrate the anniversary, Northern ... strategic market research portals that it will begin delivering to ... Light,s "Summer of Love (For Our Customers)."  ... Northern ...
(Date:6/13/2017)... , June 13, 2017 Zimmer Biomet Holdings, Inc. ... today announced that the U.S. Food and Drug Administration (FDA) ... 3, 2015 relating to its Zhejiang, China ... "The successful clearance of the Warning Letter ... manufacturing facility is a measure of the progress we have ...
(Date:6/9/2017)... ALTO, Calif. , June 9, 2017 ... device company focused on the design, manufacture, sale and ... the market on the progress of its commercial roll-out ... is now available in more than one hundred (100) ... AeroForm offers a needle-free alternative for ...
Breaking Medicine Technology: