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:2/8/2016)... ... ... Coast Dental has a new way to help parents keep their children's ... Yvonne Dorrian, DMD, is hosting a free seminar on Friday, February 19 from 2 ... 1207 North Peachtree Parkway in Peachtree City. Dr. Dorrian will have healthy snacks, activities, ...
(Date:2/8/2016)... York, NY (PRWEB) , ... February 08, 2016 , ... ... are too much to handle, you are not alone. According to the Center for ... include heart disease, stroke, type 2 diabetes and certain types of cancer, some of ...
(Date:2/8/2016)... San Francisco, CA (PRWEB) , ... February 08, 2016 , ... ... helped raise $792,000 to help combat pancreatic cancer. , Gary D. Radine, who recently ... who also was the American Cancer Society’s 2015 CEO of the Year , ...
(Date:2/8/2016)... ... February 08, 2016 , ... Discover the Rocky Mountain region’s longest ... and 700 companies. Attendees also get to see the most incredible gardens and ... Home Show , at the Colorado Convention Center - 700 14th St. Denver CO, ...
(Date:2/8/2016)... , ... February 08, 2016 , ... Guruji Mahendra Kumar ... 10th and 11th, 2016 in honor of his birthday on February 10th. During ... Mahendra Trivedi is known by over 250,000 people from over 40 different countries ...
Breaking Medicine News(10 mins):
(Date:2/8/2016)... 8, 2016 http://www.researchandmarkets.com/research/fqx6nz/global_skin ... "Global Skin Protective Equipment Market 2016-2020" report ... http://www.researchandmarkets.com/research/fqx6nz/global_skin ) has announced the addition of the ... report to their offering. --> ... announced the addition of the "Global Skin ...
(Date:2/8/2016)...   Intarcia Therapeutics, Inc. today announced the ... the newly created role of Vice President, Head of ... two decades of leadership experience at leading pharmaceutical, biotechnology, ... medical center. Most recently Dr. Yee served as VP, ... Head Medical Officer at AstraZeneca, where he led medical ...
(Date:2/8/2016)... 2016  The University of Michigan Health System in ... as part of the development of four new operating ... in the U.S. to start using new top-of-the-line neurosurgical ... chair of neurosurgery. --> Karin Muraszko ... The BrightMatter technology from Synaptive Medical – a ...
Breaking Medicine Technology: