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:2/27/2017)... ... ... The threat of nuclear warfare has long plagued this world. In July ... testing of nuclear weapons. Years later, when her co-workers began dying, Dot started searching ... Testing,” Clayton exposes the critical decisions made by agencies involved in the nuclear testing ...
(Date:2/27/2017)... , ... February 27, 2017 , ... POUGHKEEPSIE, N. Y. ... has disclosed that despite scientific studies, the Center for Disease Control ( CDC ) ... disease . Kenneth B. Liegner, M.D. has compiled into a single volume a ...
(Date:2/27/2017)... ... 2017 , ... New Jersey ranks among the top five states in the ... need for advanced services is growing. , Project WE vs C is a ... with their non-profit partners in their fight against cancer and in support of their ...
(Date:2/26/2017)... York, New York (PRWEB) , ... February 26, ... ... luxury baby products for wholesale distribution in North America, today announced it would ... online sites. The company, which prides itself on crafting quality and unique baby ...
(Date:2/26/2017)... ... February 26, 2017 , ... Occupational pesticide exposure is linked ... LRRK2 mutation, according to a study released today at the 1st Pan American ... link between pesticides and incidence of sporadic PD through occupational exposure. This latest ...
Breaking Medicine News(10 mins):
(Date:2/24/2017)... , Australien, 24. Februar 2017 ... diversifiziertes Unternehmen des Gesundheitsbereiches, ist erfreut, für das ... mit dem entsprechenden Vorjahreszeitraum exzellente Ergebnisse vorlegen zu ... und Aktualisierung zum Wachstum" finden Sie hier ... Gewinn nach Steuern 2,12 Millionen USD (Dez. 2015: 1,04 Millionen USD; ...
(Date:2/24/2017)... 2017  Directors from Pharma To Market Pty Ltd and Ador ... resulting in the founding of Pharma To Market Pte Ltd, based ... are pleased to announce their expansion into Asia ... . The company are delighted to appoint Joelle Chia ... Singapore based entity. Joelle brings with her an ...
(Date:2/24/2017)... , Feb. 23, 2017 ... insights on the various drugs being developed ... covers all the drugs that are in ... Clinical). The pipeline focuses on novel pharmacologic ... antibodies, stem cell therapies, recombinant proteins and ...
Breaking Medicine Technology: