FDA approves new type of sleep drug, Belsomra

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Nelson Vergel

Founder, ExcelMale.com
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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.

http://www.fda.gov/NewsEvents/Newsr...ivery&utm_medium=email&utm_source=govdelivery
 
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Important information about Belsomra
Do not exceed recommended dose.
Do not take this medicine unless you are able to stay in bed a full night (at least 7 hours) before you must be active again.
Take tablets within 30 minutes of going to bed.

Belsomra may cause serious side effects that you may not know are happening to you. These side effects include:
sleepiness during the day
not thinking clearly
act strangely, confused, or upset
"sleep-walking" or doing other activities when you are asleep like eating, talking, having sex, or driving a car.
Call your doctor right away if you find out that you have done any of the above activities.
 
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