FDA approves new type of sleep drug, Belsomra

catly

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Announced today 8/13/14. It won't be available to patients until the end of 2014, or early 2015.

FDA press announcement can be found here.

"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."
 
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I read about this drug about a year ago I think. I remember it because it was the first of its kind being an orexin receptor antagonist.

While most sleep aid drugs in some way effect GABA receptors this one is a completely different mechanism of action. This will be interesting to see how this turns out.
 

deleder2k

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Do we know anything about long term use? I need something that I can use every day that actually works.
 

catly

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Do we know anything about long term use? I need something that I can use every day that actually works.
That's a good question, but I'm guessing they probably didn't study long term use in clinical trials..athough it seems that the drug has been in development/studies for 10 years according to Merck. It's still pending final DEA determination as to whether or not it will be classified as a Schedule IV drug under the Controlled Substances Act before it will be available to patients.

If anyone is interested and wants to learn of updates on belsomra, you can sign up at www.belsomra.com.

I'm mostly interested in it in case Ambien stops working for me--so far I've been on it well over a year and it still works...without it, I don't sleep.

.
 
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That's a good question, but I'm guessing they probably didn't study long term use in clinical trials..athough it seems that the drug has been in development/studies for 10 years according to Merck. It's still pending final DEA determination as to whether or not it will be classified as a Schedule IV drug under the Controlled Substances Act before it will be available to patients.

If anyone is interested and wants to learn of updates on belsomra, you can sign up at www.belsomra.com.

I'm mostly interested in it in case Ambien stops working for me--so far I've been on it well over a year and it still works...without it, I don't sleep.

.

I also depend on drugs to sleep :sleep:

I do it in a combination to try and avoid tolerance.
L-Theanine, GABA, Melatonin, Trazodone, Klonopin, and the knockout punch Clonidine

If I could just take one (that works better) I would be interested.
 

catly

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I hear you, I also take L-theanine, diphenhydramine, melatonin, mirtazapine and sometimes Klonopin.

I think mostly it's the Ambien that helps.

It would be nice to not need anything to sleep, but occassionally I forget to take my ambien and I end up in a state between wakefullness and sleep that is just horrible.
 

*GG*

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Do we know anything about long term use? I need something that I can use every day that actually works.
@deleder2k I use Remeron (mirtazapine) for years now day after day, works well for me! It's an anti-depressant. used Trazadone before, worked for a few years also. Think Remeron is much better for me, wake up feeling better, not great, but not as sluggish as in the past, more rested :)

Tried an anti-depressant between the 2 meds, Doxepin, if I recall correctly, did not work at all for me, so some trial and error!

GG
 

deleder2k

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@ggingues Looks interesting. I tried Amitriptyline as a painkiller. It took away some of my pain, made me sleep 12 hours instead of 7, made me lazy and also made me feel like I didn't give a s***. Do you experience side effects?
 

*GG*

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@ggingues Looks interesting. I tried Amitriptyline as a painkiller. It took away some of my pain, made me sleep 12 hours instead of 7, made me lazy and also made me feel like I didn't give a s***. Do you experience side effects?
Perhaps you shouldn't look at it as making you "lazy", perhaps this is rest that your body needs to get healthier?!

I don't experience any side effects that I know of. I would have to research what the side effects can be.

GG
 

deleder2k

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Hm... I don't know. 12 hour sleep each day + dizziness during the day. It is a common side effect from Amitriptyline, so I don't believe that my body is getting healthier. Who knows...
 
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Hm... I don't know. 12 hour sleep each day + dizziness during the day. It is a common side effect from Amitriptyline, so I don't believe that my body is getting healthier. Who knows...

Yeah the dizziness during the day sounds like a side effect. I had the same problem with Ambien after taking it for like 5 days. I started getting really nauseous and dizzy and it would last all day and I finally figured out it was the Ambien. So you probably had the same thing going on here.
 

DeGenesis

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I think low-dose doxepin is the best sleep-aid. Mostly out of your system by the morning according to a graph on the Silenor website.

EDIT: Personal experience.
 
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heapsreal

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Is belsomra going to be approved for chronic insomnia or another med that they only really approve for 14 days.

It would be interesting too no if and how long till tolerance occurs? ?