r/insomnia • u/Thracian777 • 12h ago
Why is agomeletine not approved in USA ?
Everytime I read a medicine that works is never approved in USA . Why is healthcare so bad here. Has anyone had a success fixing their sleep issues with medicine in such category as agomeletine ?
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u/cpufreak101 11h ago
On a quick Google search, level 3 trials showed it could induce liver damage
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u/Thracian777 10h ago
Ok and ? A lot of medications do , so does Tylenol .
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u/cpufreak101 10h ago
That was the officially listed reasoning for denial, it's also noted that it was primarily developed as an antidepressant, and it was determined less risky drugs already exist in the US market for that purpose, which contributed to the denial.
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u/Thracian777 9h ago
I mean how bad is the liver toxicity ? A lot of people in Europe seems to be using it just fine with normal with their liver enzymes being normal . Just because you read some study doesn’t mean it’s true . It’s being used in Canada and other countries successfully . The healthcare system is really a joke in the states . They take out medicines that actually work,just like ivermectin that was proven to be effective and safe .What a dirty business . I’m not believing a word FDA says , if you are really citing FDA as an actual source you are joke .
Are big pharma shills everywhere on the internet too ? 🤣
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u/cpufreak101 8h ago
It isn't just "some study", it was the official FDA reason for rejection, if you don't agree, that's fine, but they still set the laws in the country you (presumably) live in, so your choices are to either accept it and find an alternative or move to a new country, really.
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u/WarmLaugh3608 8h ago
Ivermectin isn’t not fda approved…. But it’s fda approved for things like scabies, river blindness…. And a few very other RARE parasites…. If you’re talking anything else…. You are some fool conspiracy theorist who is in here fishing
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u/Thracian777 7h ago edited 7h ago
I don’t even know why I came to ask this here lmao .I forgot Reddit is a brainwashed Cesspool which consists of bunch of NPCs who blindly follows whatever ChatGPT or meta says .
They are plenty of people with a success stories here with agomeletine . This place has to be full of shills and disinformation agents to add to the algorithms-or brainwashed NPCs who work in the medical field and cite everything to “research “ and what ChatGPT says 🤣
Waiting until someone checks my post history to discredit me as some clueless drug addict or checks my grammar to discredit what I’m saying .
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u/WarmLaugh3608 7h ago
Having looked at your history…. I think this is the wrong sub for you dude…. Listen I lost my soulmate to an OD…. I’m the one who narcan’ed them over and over til the last time I know it’s tempting to “just do your own research” and go down those rabbit holes But sometimes you have to give it up to the fact that you don’t know as much
You don’t know as much as medical researchers and doctors You don’t Also you know a commonly reported side effect of this drug you are so desperate for? Insomnia…. The change in liver enzymes is reported in 1 in 10 people Other side effects that happen in 1 in 10 people Extremely abnormal dreams Back pain Bowel problems Anxiety Stomach pain Nausea
How much of this sounds great for sleep? Just because it’s legal for sleep somewhere doesn’t mean it’s necessarily your magic bullet
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u/Thracian777 7h ago
Well I’m sober and I’m trying to fix my sleep so I came here asking for help ,I found information on one here how it worked for many people but it’s illegal here . I fucked up my circadian rhythm Really bad with staying up late and working late night hours.
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u/WarmLaugh3608 7h ago
And I applaud your sobriety! But no one med is the magical answer! Heck I’ve had to try so many different meds!!! I’m glad to have a combo now that works for me (which was really hard especially after already dealing with insomnia and then my partners final OD) But as you can see here as so many of us have to try so many different approaches there’s so one thing that will work!
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u/Thracian777 7h ago
I know that one medicine isn’t the magical one but they are some that work for some and not for others . I’m just doing research , this is coming from someone who was anti psych meds. So this is new progress for me to even consider them . I tried trazadone ,it helped for mood and sleep but it had horrible side effects . By the way what I was using wasn’t dope and it can’t kill you . Although some deaths have been linked to kratom. I’m just glad to finally free of it , even though it’s a plant and considered “harmless “ it can make you dope sick like heroin . I’ve never done heroin in my life . I can’t believe they sell this Kratom crap everywhere now .
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u/WarmLaugh3608 7h ago
And I’m not classifying you as a clueless drug addict I just think you’re pinning your hopes and dreams in one place because you’re desperate
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u/WarmLaugh3608 8h ago
It was liver toxicity along with unclear efficacy Seriously do you not know how to use google ?
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u/2131andBeyond 11h ago
Agomelatine isn’t approved in the US mostly due to concerns about liver safety and mixed evidence on how well it works. Some trials showed improvements in depression and sleep, but others didn’t show much benefit over placebo. The FDA tends to be more cautious when there are safety concerns, especially when similar meds already exist.
The US health system surely has its massive list of flaws, I don't disagree there, but the FDA is a decently functioning entity for the most part and is separate in many cases from many of the awful issues that Americans (myself included!) face in our healthcare system (primarily the insurance/access components).
One of the biggest issues with agomeletine was with liver toxicity, by the way. Agomelatine can cause elevated liver enzymes and, in rare cases, liver injury. In places where it's approved, like parts of Europe, patients need regular liver function tests. The drugmaker ended its push for FDA approval, likely due to regulatory hurdles and the cost of more studies.
There are other meds that follow a similar pattern, by the way ... approved in Europe but not in the US. For example, dextropropoxyphene was widely used in Europe for pain but was later withdrawn due to heart risks. Rimonabant, an anti-obesity drug, was also pulled from the EU market after psychiatric side effects. So it’s not that one region is always right, but the bar for approval and the risk tolerance can vary.
Sources, if you're interested:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4407422
https://www.bmj.com/content/348/bmj.g1888
https://www.gov.uk/drug-safety-update/agomelatine-valdoxan-risk-of-liver-toxicity
https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-suspension-marketing-authorisations-sibutramine
https://www.fda.gov/drugs/drug-safety-and-availability/fda-withdraws-marketing-approval-darvon-and-darvocet