FDA approves new type of sleep drug, Belsomra

[maryb]

Apologies if its been explained previously but not up to reading all the thread, can anyone tell me why it is a better drug than say Zopiclone. I would love to get off this sleep med, but don't want to change it for something as addictive and damaging.

 

[heapsreal]

Apologies if its been explained previously but not up to reading all the thread, can anyone tell me why it is a better drug than say Zopiclone. I would love to get off this sleep med, but don't want to change it for something as addictive and damaging.

I don't think they can say its safer or less addictive until its been on the open market awhile. My understanding is that it works on totally different receptors to benzos and z drugs which all work on gaba receptors .

Interested to find out if anyone knows when it will be available in Australia as wouldn't mind trying it.

 

[maryb]

Can you tell me which receptors it works on @heapsreal , maybe I can look it up then when I feel up to it, as you can tell my weaning off Zopiclone wasn't successful!!. I don't know if its available in the UK, wonder if my ME doc would give me some to try if it is.
What a shame it isn't available in Oz, has it not been approved, any reason?

 

[maryb]

I just checked it out, its in Phase 111 clinical trials in the UK, so we'll see how those go. It'll be unusual if the UK doesn't follow the FDA approval.

 

[heapsreal]

Can you tell me which receptors it works on @heapsreal , maybe I can look it up then when I feel up to it, as you can tell my weaning off Zopiclone wasn't successful!!. I don't know if its available in the UK, wonder if my ME doc would give me some to try if it is.
What a shame it isn't available in Oz, has it not been approved, any reason?

Supposedly blocks orexin which i think is a type of neurotransmitter that keeps people awake. So orexin antagonist .

I haven't looked for a while if its available in oz but did ask my dr recently if there were any cures for insomnia , he just grinned and send no. I took that as a no but will look myself.

 

[geraldt52]

does it help central apneas?...

I don't know if that question was directed at me, physicsstudent13, but I don't know the answer.

As was pointed out by heapsreal, Belsomra is an orexin antagonist, and so works very differently than the other sleep medications. The trials claim to have found no tendency for dependency, but I think only time will tell.

Klonopin is just one of the plethora of benzo drugs, used in seizure disorders, but there is no question that it is effective for sleep...habituation and dependency are the issue. If benzos stop working, as they are known to do, you are in big trouble...benzo withdrawal has been said to be worse than cocaine or heroin withdrawal. I can't say, but I can say that benzo withdrawal is a living hell.

 

[Mjmouser]

I'm in the middle of doing my own trial of Belsomra, and while I'm not really ready to draw any conclusions I can say that I have taken 10, 15, and 20 mg and not had the day after hangover you describe. I'm not sure it's going to be useful to me for other reasons, but no hangover.

I'd be suspicious of combining Belsomra with Ambien or Lunesta. Personally, I'd try to be off of any other Rx sleep med for a week before trying the Belsomra. But, as you say, we're all different.

 

[Mjmouser]

I'm in the middle of doing my own trial of Belsomra, and while I'm not really ready to draw any conclusions I can say that I have taken 10, 15, and 20 mg and not had the day after hangover you describe. I'm not sure it's going to be useful to me for other reasons, but no hangover.

I'd be suspicious of combining Belsomra with Ambien or Lunesta. Personally, I'd try to be off of any other Rx sleep med for a week before trying the Belsomra. But, as you say, we're all different.

I certainly couldn't sleep a wink without the meds!!! I went directly from 15-20 mg. Ambien/night (well, my night is 10-12 hrs sleep) to 20+ mg Belsomra. 10 mg does nothing. Merck wanted 20 mg approved as standard dose, but FDA "next day function test" forced them to suggest 10 mg. I am not experiencing any hangover or any other side effects. Very vivid dreams, but they don't bother me. Feel as if I'm sleeping quite well and last night (my 8th day on Belsomra), 20 mg put me right to sleep for 8 hours. Needing a little more (I have split tablets), I took 1/4 of a 10 mg tablet and slept another 3+ hours. Google Belsomra reviews and you'll see a lot of comments about people trying the drug.

 

[5150]

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.

.

Catly, sooner or later you will have to deal with the long-term addiction to Ambien. And that is what will happen, if not already, you will be addicted. I'm just coming off about 8 years on Ambien CR, and trying to go to zero. After 6months' titrating, I'm at a 5mg roadblock. Temporarily, am substituting Remeron for the sleep, but it has long-term weight gain issues... so I don't have a plan! Just pointing out that Ambien can be a serious long-term problem, almost guaranteed anybody who uses it long-term will have problems. The big problem is that doctors keep giving it long-term, and patients sometimes can be blinded to issues due to extreme serious underlying causes of insomnia. We just want to sleep, no matter how bad the idea could be.

 

[5150]

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.

If you are a man with prostate problems, better steer clear of Doxepin. Serious side effects re urine retention.

 

[cb2]

@geraldt52 why do you think one needs to be off ambian or lunesta for a week for the belasomra to work?
also what about the slow taper of ambain and slow increase of belsomra? i tried the belasomra the past 2 nites and hardly slept at all..

 

[geraldt52]

@geraldt52 why do you think one needs to be off ambian or lunesta for a week for the belasomra to work?
also what about the slow taper of ambain and slow increase of belsomra? i tried the belasomra the past 2 nites and hardly slept at all..

It's just my opinion that the rebound effect of not having the Ambien/Lunesta, after being dependent upon them, will overwhelm the mechanism by which Belsomra is supposed to work. In the on line feedback for Belsomra there seems to be substantial support for that idea, because there is a lot of negative feedback for Belsomra by long time users of Ambien/Lunesta. Let me be clear though, cb2, that that is just my opinion...and Mjmouser's experience above indicates that it isn't going to be true for everyone.

The only way you'll know whether tapering the Ambien/Lunesta while increasing the Belsomra might work would be to experiment...and we all know how difficult that is when you're talking about sleep. But if the Belsomra doesn't work initially, I'd think it would be worth a try...it sure would help if Belsomra were helpful in breaking a dependence on Ambien/Lunesta.

My early experience with Belsomra indicates that it's dose sensitive...I got zero result from 10mg, but 15 mg got me to sleep pretty well. Maybe the first thing to do is increase your dose? Be aware that all the side effects were more common as the dose got higher though.

 

[geraldt52]

Catly, sooner or later you will have to deal with the long-term addiction to Ambien. And that is what will happen, if not already, you will be addicted...The big problem is that doctors keep giving it long-term, and patients sometimes can be blinded to issues due to extreme serious underlying causes of insomnia. We just want to sleep, no matter how bad the idea could be.

Nobody whose on sleep medications ever wants to hear that, but I do believe that pretty much sums up the situation.

Everyone clings to the idea that it won't happen to them...and then one day out of the blue it does. Once someone is in trouble, the doctors tend to just throw up their hands, because there is no easy way out of that hole.

 

[Ecoclimber]

Interesting they are targeting the orexin which is part of the hypocretin/orexin ligand-receptor system for sleep disorders. The bad news is that it could make you drowsy during the day which compounds ME/CFS symptoms. Ambien is in and out of your system in 4 hours and the reason why people wake up after it dissipates. XR version is not very effective. Different Generic mfg.brands of ambien may not be as effective as the brand name due to different fillers, coloring agents and formulatary etc. Qualtest seems the closest to the brand in size and shape.

Some patients build up a resistance to the drug have found relief from changing to different sleep medication. In many ME/CFS patients there seems to be an indication of circadian rhythm disturbance. Other patients go with a Zen like flow and allow there body to adjust to the difference time schedule by staying awake at night and sleep during the day without using any dependency on sleep meds. Hmm, I wonder if you move to a different location where your normal day is night, you would then sleep at night?

Sleep doctors also use a power sleep aide xyrem. It was commonly purchase at one time as an over the counter but was pulled as it was used as a date rape medication. In other words, it has a serious side effect of sleep walking; you could get in your car and start driving without realizing you are asleep!

 

[catly]

Catly, sooner or later you will have to deal with the long-term addiction to Ambien. And that is what will happen, if not already, you will be addicted. I'm just coming off about 8 years on Ambien CR, and trying to go to zero. After 6months' titrating, I'm at a 5mg roadblock. Temporarily, am substituting Remeron for the sleep, but it has long-term weight gain issues... so I don't have a plan! Just pointing out that Ambien can be a serious long-term problem, almost guaranteed anybody who uses it long-term will have problems. The big problem is that doctors keep giving it long-term, and patients sometimes can be blinded to issues due to extreme serious underlying causes of insomnia. We just want to sleep, no matter how bad the idea could be.

After crashing severely over 2 years ago--for no apparent reason--just that I could NOT sleep more than an hour or so day after day--I really don't care that much now if I'm "addicted" to Ambien. To me, not sleeping is worse. Fortunately I've slowly improved over the last year or so to where I am pretty functional. But I can not sleep without Ambien. I start each night with 5 mgs, sometimes that's all I need, sometimes I need another 5mgs.

I've tried amitriptyline (worked for a couple of months) Trazadone (worked for 2 weeks and made me feel HORRIBLE), and mirtazapine (worked for 1 week and made me gain 20 pounds within 2 months). No more antidepressants for me, the anti-histamine effect wears off really rapidly.

I've also tried Klonopin 0.5 mgs but that does nothing for me and I'm afraid to take more.

As long as Ambien works, I can afford it (cost me $5 for 30 days) and I can get someone to prescribe it, I will use it and not worry about long term effects as the short and long term effects of not sleeping are horrible for me. Now if I could afford Belsomra, and it worked I would switch but for now the price is out of the question.

All those trying Belsomra, I appreciate your continued feedback, maybe someday my insurance company will cover it.

 

[5150]

After crashing severely over 2 years ago--for no apparent reason--just that I could NOT sleep more than an hour or so day after day--I really don't care that much now if I'm "addicted" to Ambien. To me, not sleeping is worse. Fortunately I've slowly improved over the last year or so to where I am pretty functional. But I can not sleep without Ambien. I start each night with 5 mgs, sometimes that's all I need, sometimes I need another 5mgs.

I've tried amitriptyline (worked for a couple of months) Trazadone (worked for 2 weeks and made me feel HORRIBLE), and mirtazapine (worked for 1 week and made me gain 20 pounds within 2 months). No more antidepressants for me, the anti-histamine effect wears off really rapidly.

I've also tried Klonopin 0.5 mgs but that does nothing for me and I'm afraid to take more.

As long as Ambien works, I can afford it (cost me $5 for 30 days) and I can get someone to prescribe it, I will use it and not worry about long term effects as the short and long term effects of not sleeping are horrible for me. Now if I could afford Belsomra, and it worked I would switch but for now the price is out of the question.

All those trying Belsomra, I appreciate your continued feedback, maybe someday my insurance company will cover it.

Hi Catly, I am in the same situation as you. . . just cannot fall off that ledge into sleep w/o medication, and Ambien really has been all that addresses that problem for me. I have tried all the alternatives you listed, with the same results that you have. Now I'm at 5mg/night and thinking of staying there awhile, while stopping the crazy Remeron altogether. Re finding the next better sleep aid , it's tough. I don't have it yet. What doc prescribes Xyrem? never met one yet; and it does sound sketchy since its' use has been hijacked by the date rape cowards.

I would say if you can keep Ambien at 5 or 7.5 mg/night, why not. However, we must know about the definite dependence issue & probable addiction, too. It's a challenging position.

Best to you.

 

[LifeIsSweet]

I've been taking Belsomra twice a week since it became available in the US. I had been anxiously awaiting it's approval for over two years. For me, it does not work well at all. I get about 4 or 5 hours of poor sleep. That is of course better than ZERO sleep which I get when I don't take anything. I take 20 mg pills. Any less and it's absolutely ineffective.

So, about sleeping pills for a severe insomniac - I think it's best to cycle meds with different mechanisms of action. I do this because I build up a tolerance to a medication within just a couple of weeks of taking it regularly. And tolerance means having to go through withdrawals. And that's no fun.

Here's my schedule:

Monday night - Trazodone - 50 mg or Mirtazepine 15 mg. I alternate between them.
Tuesday night - Ambien - 10 mg
Wednesday - Trazodone
Thursday - Belsomra 20 mg
Friday - Ambien
Saturday - Trazodone
Sunday - Belsomra

Ambien works on GABAa receptors
Trazodone - they don't know how it works but it's not on GABA
Mirtazepine - antihistamine (works but causes massive weight gain for me)
Belsomra - Orexin blocker

I may try Xyrem (aka GHB or Sodium Oxybate or the "date rape drug") once a week. It works on GABAb receptors.
I know that 5htp and L-Tryptophan work via seratonin and melatonin. They aren't strong enough for me. Valerian, Magnolia Bark and sun-theanine work on GABAa. Whatever you do, DO NOT TAKE BENZODIAZEPINES. They may seem like the answer to your prayers, but they are incredibly addictive and are hell to withdraw from. I nearly died from withdrawal from a small dosage of Valium. It ruined me, and I attribute the horrific withdrawal as one of the main causes of my CFS and Fibromyalgia. I justify taking Ambien 2 times a week because it isn't as powerful as benzos.

I don't want to take any of these meds, as I feel they are contributing to my severe CFS. But, it's hard to take nothing because taking nothing means LITERALLY no sleep. I imagine after months of no or very little sleep my body would learn to produce GABA and melatonin on its own. But, getting through those months would be excruciating.

Anyway, I don't know if this helps.

 

[cb2]

I like your dosing schedule @LifeIsSweet i alternate things too but dont have it down to a science yet. and sometimes i mix and match a bit. is flexiril a benzo? i couldn t get the belsomra to work for me even at the 20mg. sometimes the ambian stops working too. one dr told me it is ok to use a benedryl with flexiril. will give that a try- but i tend to get next day wipe out with sleep meds as well.

 

[LifeIsSweet]

No, Flexiril isn't a benzo. I think it's chemically related to tricyclic antidepressants but I don't think it causes weight gain. It's a muscle relaxant. I guess it helps with sleep for some but I can't imagine how. Ambien doesn't work for you even at only two days a week? All of these drugs wipe me out the next day. Benedry scares me (I used to take 6 a night!) because it's been implicated in Alzheimer's Disease. Yikes. I would love to get off all these dang sleeping pills, but fear my CFS would get much worse without any sleep at all.

 

[minkeygirl]

does it help central apneas? ambien helps me a bit but klonopin is the most effective, I feel brain damaged without it and foggy and exhausted on waking up even on an asv. maybe klonopin works by increasing sleep continuity which one neurologist is the key to treating centrals

Klonopin is not a sleep medication, it's an anti seizure medication, also anti anxiety. Maybe that is why you feel better with it. It calms your brain down. Sleeping is a "side product" of it.