Navigation Links
FDA Approves New Kind of Insomnia Drug
Date:8/14/2014

WEDNESDAY, Aug. 13, 2014 (HealthDay News) -- A new prescription insomnia drug that's the first of its kind was approved by the U.S. Food and Drug Administration on Wednesday.

Belsomra (suvorexant) tablets are approved to treat patients with insomnia, which means they have difficulty falling and staying asleep.

The new sleep drug is called an orexin receptor antagonist and it works by altering the action of the brain chemical orexin, which helps regulate the sleep-wake cycle and also helps keep people awake.

"To assist health care professionals and patients in finding the best dose to treat each individual patient's sleeplessness, the FDA has approved Belsomra in four different strengths -- 5, 10, 15 and 20 milligrams [mg]," Dr. Ellis Unger, director of the Office of Drug Evaluation I in the FDA's Center for Drug Evaluation and Research, said in an agency news release.

"Using the lowest effective dose can reduce the risk of side effects, such as next-morning drowsiness," he added.

Belsomra should be taken only once a night, within 30 minutes of going to bed, and with at least seven hours remaining before the planned time of waking. The total dose should not exceed 20 mg once daily, the FDA said.

The drug's approval was based on the findings of three clinical trials that included more than 500 people, the agency said. The results showed that people who took Belsomra fell asleep faster and spent less time awake during the night than those who took a placebo.

Belsomra was not compared to other insomnia drugs, so it's not known if there are differences in safety or effectiveness, the FDA said.

The agency asked Belsomra maker Merck, Sharpe & Dohme Corp. to study next-day driving performance in people who had taken the drug. Both men and women had impaired driving skills when they took the 20-mg dose, which means that people who take that maximum dose should be cautioned to avoid driving or other activities that require full mental alertness the next day, the FDA said.

Even those who take lower doses should be cautioned about possible sleepiness the next day, because individuals have different sensitivities to drugs, the agency noted.

More information

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

SOURCE: U.S. Food and Drug Administration, news release, Aug. 13, 2014

--


'/>"/>
Copyright©2014 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. FDA Approves Highly Accurate At-Home Colon Cancer Test
2. FDA Approves New Type 2 Diabetes Drug
3. FDA Approves New Treatment for People With COPD
4. FDA Approves Hard-to-Abuse Narcotic Painkiller
5. NQF Board Approves Trial Period to Test Impact of Risk Adjustment of Performance Measures for Sociodemographic Factors
6. FDA approves many drugs that predictably increase heart and stroke risk
7. FDA approves first targeted drug for advanced stomach cancer
8. Augusta Maine Chocoholic, Adam Green, Approves Xocai's "Change Your Chocolate" Success to Demand for Raw Blueberry in Nagoya, Japan and Taipei, Taiwan
9. German Research Foundation approves research unit to study extreme experiences in life
10. FDA Approves Memory Shape Silicone Implants
11. Branches' Ways to Work Program Approves 60th Car Loan
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Approves New Kind of Insomnia Drug
(Date:6/26/2016)... ... , ... Pixel Film Studios Released ProSlice Levels, a Media Slicing Effect ... a whole new perspective by using the title layers in ProSlice Levels to ... ProSlice Levels contains over 30 Different presets to choose from. FCPX users ...
(Date:6/26/2016)... ... June 26, 2016 , ... Many women are ... with endometriosis. These women need a treatment plan to not only alleviate symptoms ... can help for preservation of fertility and ultimately achieving a pregnancy. The specialists ...
(Date:6/25/2016)... Miami, FL (PRWEB) , ... June 25, 2016 , ... The temporary closing of Bruton ... Plant City Observer , brings up a new, often overlooked aspect of head lice: ... The closing for fumigation is not a common occurrence, but a necessary one in the ...
(Date:6/25/2016)... CA (PRWEB) , ... June 25, 2016 , ... As ... with Magna Cum Laude and his M.D from the David Geffen School of Medicine ... and returned to Los Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive ...
(Date:6/25/2016)... ... ... Conventional wisdom preaches the benefits of moderation, whether it’s a matter of indulgence ... high can result in disappointment, perhaps even self-loathing. However, those who set the bar ... from PsychTests.com reveals that behind the tendency to set low expectations is ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... 2016  MedSource announced today that it has ... solution of choice.  This latest decision demonstrates MedSource,s ... their clients by offering a state-of-the-art electronic data ... nowEDC as the EDC platform of choice in ... "nowEDC has long been a preferred EDC platform ...
(Date:6/23/2016)... Research and Markets has announced ... Type (Organic Chemical (Sugar, Petrochemical, Glycerin), Inorganic Chemical), Functionality ... - Global Forecast to 2021" report to their ... global pharmaceutical excipients market is projected to reach USD ... in the forecast period 2016 to 2021. ...
(Date:6/23/2016)... Research and Markets has announced the ... 2016 - Forecast to 2022" report to their offering. ... up to date financial data derived from varied research sources ... with potential impact on the market during the next five ... comprises of sub markets, regional and country level analysis. The ...
Breaking Medicine Technology: