Belsomra: Drugs You Don't Need for Disorders You Don't Have.

[Remy]

Merck itself says that it is ineffective at the dose approved by the FDA. Yet they're still selling it and it's on track to be a best-seller.

Don't be tempted because studies show it just plain doesn't work.

People taking Belsomra fell asleep, on average, only six minutes sooner than people taking a placebo and stayed asleep for a mere 16 minutes longer. Some test subjects experienced worrying side effects, like next-day drowsiness and temporary paralysis upon waking. For a number of people, these effects were so severe that the researchers halted their driving tests, fearing someone would get into an accident. Because of these safety concerns, the FDA ended up approving the drug at a lower starting dosage than the company had requested—a dosage so low that a Merck scientist admitted it was “ineffective.”

Full text here.

 

[Who Me?]

I've seen some reviews about this and they sure didn't justify the cost.

 

[GG]

Ah, I've seen the ads. Was curious about it, Zolpidem works for me, so drs wouldn't prescribe anyways.

GG

 

[ShyestofFlies]

Oh boy, I have sleep paralysis already I definately don't need a med with that as the side effect, thanks for the heads up.

 

[Mavis and Max]

Merck itself says that it is ineffective at the dose approved by the FDA. Yet they're still selling it and it's on track to be a best-seller.

Don't be tempted because studies show it just plain doesn't work.



Full text here.

True and not true. I know someone affiliated with Belsomra on the clinical side and know that it impacted deeper stages of sleep (doesn't work on getting you asleep - so you need good sleep hygiene for it to work) but it helps people stay asleep 20 minutes longer at the current, FDA-approved dose. But the higher dosage (off label) has a big impact. Participants (without ME/CFS) in the RCT did not have the sleep-drug hangover that other drugs.

My question is if anyone here has used it with ME/CFS? In this previous column, there was a lot of enthusiasm: http://www.healthrising.org/blog/20...-suvorexant-expected-to-hit-market-this-year/

 

[Who Me?]

The link you cited was a blog. So I don't think anyone was saying it was great from personal experience. More about introducing a new drug. I don't think it was geared to mecfs

Also the cost is outrageous from what I saw in goodrx.

 

[Mavis and Max]

The link you cited was a blog. So I don't think anyone was saying it was great from personal experience. More about introducing a new drug. I don't think it was geared to mecfs

Also the cost is outrageous from what I saw in goodrx.

Yes - I agree that it was enthusiasm for the future. Given that, I was just wondering if any of that enthusiasm led people here to try it. I can imagine the price is a huge barrier.

 

[Who Me?]

@Strike me lucky i think it just came out so could be a few years for generic

I think someone on another mecfs forum wasn't that impressed. Here's the link

http://forums.phoenixrising.me/index.php?threads/fda-approves-new-type-of-sleep-drug-belsomra.31990/

 

[Who Me?]

@Strike me lucky it came out in 2014. Isn't the patent for 10 years?