ProHealth fibromyalgia Vitamin and Natural Supplement Store and Health
Home  |  Log In  |  My Account  |  View Cart  View Your ProHealth Vitamin and Supplement Shopping Cart
800-366-6056  |  Contact Us  |  Help

|
|
|

Trending News

Drug Combo in Pridgen Antiviral Fibromyalgia Trial Identified – Some Results Available

7 Fibromyalgia Seasonal Stress Strategies

Blunted Anti-Inflammatory Response to Exercise Increases Fibromyalgia Symptoms

Fibromyalgia Associated with Coronary Heart Disease

Happiness, Gratitude and Appreciation

Cytokine and Chemokine Profiles in Fibromyalgia, RA and Lupus: A Potentially Useful Tool in Differen...

FDA Approves Hysingla ER – Extended-Release Hydrocodone with Abuse-Deterrent Properties

5 Safety Tips for the Holidays for Persons Living with Fibromyalgia and Myofascial Pain Syndrome

Sense of Smell Impaired in Fibromyalgia Patients

Energy Breakthrough - One Fibromyalgia Patient’s Fortuitous Discovery

 
Print Page
Email Article

FDA Approves New Type of Sleep Medication

  [ 21 votes ]   [ 1 Comment ]
www.ProHealth.com • August 14, 2014


FDA Approves New Type of Sleep Medication. Image by
Image by "David Castillo Dominici" courtesy of FreeDigitalPhotos.net
FDA, August 13, 2014 – The U.S. Food and Drug Administration today approved Belsomra (suvorexant) tablets for use as needed to treat difficulty in falling and staying asleep (insomnia).
Belsomra is an orexin receptor antagonist and is the first approved drug of this type. Orexins are chemicals that are involved in regulating the sleep-wake cycle and play a role in keeping people awake. Belsomra alters the signaling (action) of orexin in the brain.

Insomnia is a common condition in which a person has trouble falling or staying asleep. It can range from mild to severe, depending on how often it occurs and for how long. Insomnia can cause daytime sleepiness and lack of energy. It also can make a person feel anxious, depressed, or irritable. People with insomnia may have trouble with attentiveness, learning, and memory.

“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,” said Ellis Unger, M.D., director of the Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research. “Using the lowest effective dose can reduce the risk of side effects, such as next-morning drowsiness.”

Belsomra should be taken no more than once per night, within 30 minutes of going to bed, with at least seven hours remaining before the planned time of waking. The total dose should not exceed 20 mg once daily.

The most commonly reported adverse reaction reported by clinical trial participants taking Belsomra was drowsiness. Medications that treat insomnia can cause next-day drowsiness and impair driving and other activities that require alertness. People can be impaired even when they feel fully awake.

The FDA asked the drug manufacturer, Merck, Sharpe & Dohme Corp., to study next-day driving performance in people who had taken Belsomra. The testing showed impaired driving performance in both male and female participants when the 20 mg strength was taken. Patients using the 20 mg strength should be cautioned against next-day driving or activities requiring full mental alertness. Patients taking lower doses should also be made aware of the potential for next-day driving impairment, because there is individual variation in sensitivity to the drug.

The effectiveness of Belsomra was studied in three clinical trials involving more than 500 participants. In the studies, patients taking the drug fell asleep faster and spent less time awake during the remainder of the night compared to people taking an inactive pill (placebo). Belsomra was not compared to other drugs approved to treat insomnia, so it is not known if there are differences in safety or effectiveness between Belsomra and other insomnia medications.

Like other sleep medicines, there is a risk from Belsomra of sleep-driving and other complex behaviors while not being fully awake, such as preparing and eating food, making phone calls, or having sex. Chances of such activity increase if a person has consumed alcohol or taken other medicines that make them sleepy. Patients or their families should call the prescribing health care professional if this type of activity occurs.

Belsomra will be dispensed with an FDA-approved patient Medication Guide that provides instructions for its use and important safety information. Belsomra is a controlled substance (Schedule-IV) because it can be abused or lead to dependence.

Belsomra is made by Merck, Sharpe & Dohme Corp. of Whitehouse Station, N.J.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Source: FDA News Release, August 13, 2014.


Please Discuss This Article:   Post a Comment 

Side Effects
Posted by: ruthm57
Aug 15, 2014
What are the known side effects apart from drowsiness the following day. I ask as some 'wonder' sleep meds have not been so good when considering the side effects.....Stillnox....
Reply Reply
 
Free Chronic Fatigue Syndrome and Fibromyalgia Newsletters
Subscribe to
Our FREE
Newsletter
Subscribe Now!
Receive up-to-date ME/CFS & Fibromyalgia treatment and research news
 Privacy Guaranteed  |  View Archives

Save on Nutritional Supplement Orders

Featured Products

Optimized Curcumin Longvida® by ProHealth Optimized Curcumin Longvida® by ProHealth
Supports Cognition, Memory & Overall Health
Energy NADH™ 12.5mg Energy NADH™ 12.5mg
Improve Energy & Cognitive Function
Hydroxocobalamin Extreme™ Hydroxocobalamin Extreme™
The B-12 your brain needs for detox & sharpness
B-12 Extreme™ B-12 Extreme™
The Most Potent Vitamin B-12 on Earth
FibroSleep™ by ProHealth FibroSleep™ by ProHealth
The All-in-One Natural Sleep Aid

Natural Remedies

Preserving Cognitive Function with Aging Preserving Cognitive Function with Aging
IBS, Crohn’s Disease, Colitis, and Other Digestive Disorders IBS, Crohn’s Disease, Colitis, and Other Digestive Disorders
Magnesium + Malic Acid: One-Two Punch for Pain & Fatigue Magnesium + Malic Acid: One-Two Punch for Pain & Fatigue
The Revolutionary 'Good Fat' That Promotes Heart, Brain, Bone and Joint Health The Revolutionary 'Good Fat' That Promotes Heart, Brain, Bone and Joint Health
Itching to Find Dry Skin Relief? Itching to Find Dry Skin Relief?

FIBROMYALGIA RESOURCES
What is Fibromyalgia?
Fibromyalgia Diagnosis
Fibromyalgia Symptoms
Fibromyalgia Treatments
| CFS RESOURCES
What is CFS?
ME/CFS Diagnosis
ME/CFS Symptoms
ME/CFS Treatments
| FORUMS
Fibromyalgia
ME/CFS
ADVANCED MEDICAL LABS
WHOLESALE  |  AFFILIATES
GUARANTEE  |  PRIVACY
CONTACT US
LIBRARY
RSS
SITE MAP
ProHealth on Facebook  ProHealth on Twitter  ProHealth on Pinterest  ProHealth on Google Plus
Credit Card Processing