BELSOMRA

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winnie
Posts: 6
Joined: Fri Dec 28, 2012 10:44 am

BELSOMRA

Post by winnie »

Has anyone given any thoughts to this new sleep drug? I think it sounds extremely interesting.

FDA approves Belsomra, a new prescription sleep drug

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.

http://www.fda.gov/NewsEvents/Newsroom/ ... 409950.htm

I have an appointment tomorrow with my neruo doc. I am going to ask about this. I will let you know what he has to say.

Polar Bear
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Re: BELSOMRA

Post by Polar Bear »

I haven't (here in UK) heard of this new drug.... will be interested to hear what your doctor has to say about it.
Good luck.
Betty
https://www.mayoclinicproceedings.org/a ... 0/fulltext
Opinions presented by Discussion Board Moderators are personal in nature and do not, in any way, represent the opinion of the RLS Foundation

QyX

Re: BELSOMRA

Post by QyX »

Sound's promising. Can't wait until they launch it in the EU. Might still take a year so I will convince my Doctor to write a prescription and then import it over international pharmacy. My current solution (taking Seroquel and blocking side effects with Dextroamfetamine is unstable and it is only a matter of months when this hole thing is going to crash!)

Sojourner
Posts: 1657
Joined: Tue Dec 05, 2006 5:56 am
Location: USA

Re: BELSOMRA

Post by Sojourner »

I would have been very interested in comparitive studies with other sleep agents and hope they might happen in the future. But, it sounds hopeful.
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pjmccoy1
Posts: 80
Joined: Wed Sep 11, 2013 7:00 pm
Location: Below the Mason Dixon Line USA

Re: BELSOMRA

Post by pjmccoy1 »

My Pdoc was going to give me samples to try for ridiculous insomnia only if my RLS sleep doc was in agreement. Sleep doc was opposed since I am the Queen of Side effects and highly Rx sensitive. So... didn't get to try the samples. I understand, "low and slow" is the treatment mantra with me. Been lopping off Rx's the last 2.5 months trying to find out which ones might be the offending agent. So ready for sleep. QyX, I miss the Seroquel, it at least gave me some relaxation, never but me in a good sleep, but gave me maybe 2-3 hrs before waking, currently all I get from adding back Horizant and .75mg clonazepam are catnaps... I sure hope your current regiment doesn't crash. Aren't you in school?
PJ, Heaven Bound

QyX

Re: BELSOMRA

Post by QyX »

Yes, I am in school. I study Medicine at the Charité Medical School (Charité Universitätsmedizin Berlin).

I am still working on obtaining a script for BELSOMRA. I wrote my old Doc but he hasn't called me yet and my appointment with my new Neurologist won't be until the 27th of April. She is the anxious type but I hope I will be able to convince her.

I really do hate the Seroquel. Getting up in the morning is such a pain!

And Dopamine Antagonist like Seroquel are just bad bad bad for motivation (and for RLS).

Suvorexant could just be the magic drug I was waiting for.

If it works, I would be able to stop Seroquel, Dextroamfetamine and Chlorprothixine which I take to boost the Seroquel a little bit and keep the dose low.

Dopamine Antagonist and antihistamine agents are just bad bad bad when you have RLS.

I tolerate them for now because Carbamazepine and Dextroamphetamine help a lot but I am tired of taking so many pills and I don't like the way Seroquel sedates me. There is no problem getting 9 hours of sleep but I don't think the sleep quality is really good. The sedation of Seroquel keeps me sleeping. Sometimes I wake up with unpleasant feelings in my leg. Then I take a low dose of dextroamphetamine (2,5 mg) and continue my sleep. It works but it is somehow real sick.

When I see other students in my class and think about telling them what I take ... I guess they will thing I am some kind of "pill psycho", taking high potent opioids, amphetamine at nights, potent antipsychotics ... what the hell ... nobody would like to go out with some crazy guy who takes stuff like this.

And so often, it all feels like that it has been my fault, that it is a lack of discipline, that taking opioids is not really necessary. I know better but this is the way it feels. When at least the antipsychotics for sedation and sleep at night would go away, I would feel much better.

pjmccoy1
Posts: 80
Joined: Wed Sep 11, 2013 7:00 pm
Location: Below the Mason Dixon Line USA

Re: BELSOMRA

Post by pjmccoy1 »

I wish I had taken the samples and just held onto them and added to my stash of medicine cabinet Rx's that I have failed but for some reason or another have never thrown them all out, I would have taken the risk and mailed them your way. Mine and your luck we'd both be in big trouble. Maybe when you graduate from Med School you will have more empathy for patients that suffer with chronic illness. Here in the U.S., most physicians simply treat the disease, or the side effects, rather than what FNP's tend to do, treat the patient. I am fortunate that my RLS doc (Sleep specialist/Pulmonolgist) also suffers with RLS but she isn't taking anything yet but eating iron rich foods, especially red meat like crazy and exercising a lot. But she, like myself, most likely didn't start experiencing the symptoms until her late 30's early 40's. So... it's still early and if the RLS progresses like mine did, when she hits late 40's and 50 mark it won't be so easy. However, I personally believe that Dopamine Agonist (especially the evil Carbidopa/Levadopa that we all know is probably the worse for augmentation) may in the long run, jump start the progression of RLS. That 's just my opinion based on my own personal experience. I'm also wondering how/what DA's do to screwing up glutamate levels which apparently is another problem that causes primary insomnia unrelated to RLS but often found in RLS sufferers. So, my hypothesis is perhaps the increased glutamate levels found in many RLS sufferers who experience insomnia unrelated to RLS symptoms may be a result of DA's. My theory comes from the fact that Bupropion 100sr, which is a DNRI (dopamine noradrenaline-reuptake inhibitor) a RLS friendly A/D, and in my case, actually reduces RLS significantly (even at the clinically effective dose of 150mg sr) also carries with it a high percentage of insomnia side effect. Anyhow, I wonder what will happen to my RLS "if" my treatment resistant major depression ever gets better and I can come off the Bupropion... will I experience worsening RLS or some kind of eventual augmentation???... Here's a study on both the Bupropion and RLS, as well as, the glutamate problems and insomnia in RLS patients.
http://www.psychweekly.com/aspx/article ... icleid=100
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3716406/
PJ, Heaven Bound

QyX

Re: BELSOMRA

Post by QyX »

Ya, I also suspect trouble with the glutamate. I was looking for glutamate antagonists but there are no drugs who work the way they would need to work.

I have some experience with Bupropion, too. The first two weeks it had a moderate stimulating effect but then everything turn around and it made me sleepy as hell. I took the drug and one hour I was off sleeping. Unfortunately this effect was not really predictable and I had to sleep for at least 12 hours before I was able to get up again.

Suvorexant is really something complete new and is in many ways very promising to deal with chronic insomnia related to RLS.

There might be some truth about your DA theory. My opinion is that DA only should be used for diagnostic and short term treatment. If long term treatment is necessary people should be put on opioids as soon as possible.

Until now I haven't heard about one case were a patient developed a tolerance against opioids.

Opioids are the best treatment options for RLS but they are no solution to chronic insomina.

pjmccoy1
Posts: 80
Joined: Wed Sep 11, 2013 7:00 pm
Location: Below the Mason Dixon Line USA

Re: BELSOMRA

Post by pjmccoy1 »

How unusual bupropion made you sleepy. I have to take it no later than 7 a.m. The insomnia is not as bad as it was originally but I was also taking the very low dose methadone at the the time which was also alerting for me. The combination was almost 95% coverage for RLS just the insomnia problems and then had some possible sicca symptoms related to auto-immune so had to start lopping off Rx's to see which one might offending agent that was causing dryness and swallowing issues. Anyhow, it's too bad you couldn't use the bupropion for both sleep and RLS treatment, that is if it was helpful for RLS. My RLS sleep specialist will not allow be to try Belsomra since it's so new and I seem to be very sensitive to most all Rx's.
PJ, Heaven Bound

Rustsmith
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Location: Colorado Springs, Colorado

Re: BELSOMRA

Post by Rustsmith »

I received a prescription for Belsomra two weeks ago from my doctor because nothing else seems to work for me. No matter what sleep aid I take, I wake up at 2 to 3A regardless of what time I go to bed. My doctor provided the prescription along with the statement that he had no idea whether Belsomra would be effective for RLS induced insomnia because not testing has been done on us.

Well, my insurance company has refused to pay for it. Between my wife and I, we have had them pay for some VERY expensive medications and this is the first time that they have refused to cover something. As I understand it, the list price runs somewhere around $7000 for a 30 day supply. There is also a caveat buried in the literature that after about 30 days of use, the sleep benefits begin to lessen. So this is not a medication that you can take continually (even if you could afford to).

However, I found that Merck is currently offering a 10-day trial supply for anyone who has a doctor's prescription. All you need to do is go to their website, print a voucher and take it to the pharmacy along with the prescription.

In their literature, Merck is quite blunt. Do NOT take Belsomra if you cannot commit to 8 hrs for sleep. I have now taken it two times and completely understand their point. Notice that I did not say anything about actually getting 8 hrs of sleep. Belsomra provided me with about an extra hour of sleep, but this still means that I woke up at 4A. The problem is that after I got up, my mind was so foggy that I could not really do very much that requires any thought until it wears off. The first night it took 12 hrs before I felt like I could afford to try to do something that required close concentration. The second time, I was only foggy for about 10 hrs. It will be at least a week until my schedule will allow me to experiment again, but at this point I do not believe that it is significantly better than some of the other sleep aids I have tried, like the z-drugs.
Steve

https://www.mayoclinicproceedings.org/a ... 0/fulltext
Opinions presented by Discussion Board Moderators are personal in nature and do not, in any way, represent the opinion of the RLS Foundation, and are not medical advice.

pjmccoy1
Posts: 80
Joined: Wed Sep 11, 2013 7:00 pm
Location: Below the Mason Dixon Line USA

Re: BELSOMRA

Post by pjmccoy1 »

Rustsmith wrote:Well, my insurance company has refused to pay for it. Between my wife and I, we have had them pay for some VERY expensive medications and this is the first time that they have refused to cover something. As I understand it, the list price runs somewhere around $7000 for a 30 day supply. There is also a caveat buried in the literature that after about 30 days of use, the sleep benefits begin to lessen. So this is not a medication that you can take continually (even if you could afford to).


You have got to be kidding me, $7000/month! The more I read about Big Pharma the more my blood boils. I guess the Horizant/Gabapentin cocktail you were trying has worn off. So sorry. Horizant is doing nothing for my sleep and minimal help for the RLS. It might be helping with nighttime RLS but the daytime RLS still seems to flare earlier and with new symptoms during the day now. I know many have to take Rx's for horrific health conditions, especially chronic diseases or pain. But I cannot help but wonder if I had never taken the first Zoloft and Clonazepam (prior to RLS) for a short term depression and anxiety would I have ever developed RLS? Then RLS takes me down the medication maze to Rx'g Neurontin, then the evil Carbidopa/Levadopa, then Horizant, then ripping Horizant due to depression left with only clonazepam, severe refractory depression, insomnia, anxiety-(resulting from failing multiple Rx crazy-go-round). Maybe if I knew about Functional Integrative physicians that might have considered trying first nutrition changes at the early onset of depression and then RLS symptoms only 2 -3 times a week might I never wound up with worsening RLS not to mention the bonus of auto-immune disorder to boot. Oh well, shoulda coulda woulda never changes the past. I am so sorry about insomnia issue on top of the RLS... it's simply brutally cruel.

Thank you for forewarning everyone so they won't get their hopes up only to find out 1) insurance may not cover "new wonder drug" and 2) the hidden side effects, that are deceptive thinking you will need plenty of time for 8 hours of sleep AT NIGHT, rather then spillover incapacitating grogginess to the next day and 3) effectiveness will probably wear off eventually. Shame, shame on Merck.
PJ, Heaven Bound

Rustsmith
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Re: BELSOMRA

Post by Rustsmith »

PJ, I don't want to mislead anyone into thinking that gabapentin has stopped working for me. It is still effective in that it allows me to go to sleep "normally" in the evening. The only problem is that it has a half life of something like six hours, so I end up waking up about 4 hours later when the dose starts to wear off. I am taking "a heavy dose" (my doctor's words), so I can't just pop a couple more and go to sleep again in the AM. That is why I have been on a quest to find something that is more effective.

As for Belsomra's effectiveness declining with time, you need to keep in mind that the only sleep aids that the FDA has given approval for long term use are the benzo's and Lunesta. Everything else is supposed to only be used to treat short term problems, and that includes Belsomra, Sonata, Rozerem and Ambien.
Steve

https://www.mayoclinicproceedings.org/a ... 0/fulltext
Opinions presented by Discussion Board Moderators are personal in nature and do not, in any way, represent the opinion of the RLS Foundation, and are not medical advice.

EdSoFlo
Posts: 34
Joined: Tue Jan 06, 2015 4:44 am

Re: BELSOMRA

Post by EdSoFlo »

My neuro told me about Belsomra (I'm suffering currently from major augmentation from Sinemet and am having, of course, horrible sleep issues. The 'z' class drugs are no good for me, temazepam is OK but I my tolerance builds very quickly, he said this is new, let's try it) and I utilized the free 10-pill sample pack at 15 mg (coupon is on their website.) PS I'm not sure where, if anywhere, it's $7000 per month, but it lists at around $325 for 30 pills (bad enough IMO.) This is one weird medication...I took it very early as my doc said make sure to allow a full 7 hours, about 9 PM. I was out by 930, then wide awake by 130, as if I'd never taken anything. I flipped and flopped around until finally giving up at 3, got up, made coffee, etc. I was foggy as could be until literally about 5 pm that evening, could hardly do even the simplest mental tasks, driving was very dodgy. And it was a different foggy from a sleep deprivation one, or from other meds I've used in past, just a brain dead haze. Would not recommend this one at all, though of course everyone's reaction will differ.

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