If I could trust where I get my melatonin from, I would gladly take it. But I've learned too much about how terrible this industry is.
If I could trust where I get my melatonin from, I would gladly take it. But I've learned too much about how terrible this industry is.
This also means that people with depression or sleep disorders can not be prescribed these products as they are not FDA approved and insurance will not pay for it either. This forces people into patented phara drugs that may or may not be better for them and in all cases have more side effects (upto including death being common disclaimer on the long list).
Same issue in the UK and more so in that melatonin is not allowed to be sold. Sure you can get it on the internet, but from some contries but as there are no standards it is hard to tell. Is it syntheticly made or the type extracetd from animal and with that the whole area of concern starts to rise.
If only some benificial billionair would fund FDA tests for approval for this and other unpatentable naturaly occuring medicines. Certainly be positive for everybody.
That said, there isn't much incentive for a company to do this. Let's say a company spend $200M getting FDA approval for melatonin. Considering the huge population that it would be used in, the FDA would require a very large trial to determine safety. Once launched, the drug company would need to recover that cost plus a profit, so suddenly melatonin goes from a few pennies per dose to several dollars. The push back from the public would probably kill any chance of making it a profitable venture.
What drug companies did do was create melatonin analogues. Rozerem by Takeda is a great example. It hasn't done that well.
As for omega-3s, GSK did get Lovaza approved by the FDA although they did have a patent on it (a specific form of omega-3s).
Sad about the investment needed for the limited return window which would be enough time to promote the benifits intime for the market to mature just outside the window of opertunity.
Does make you wonder how many good useful medications are kept back due too fiscal investment to get the various approvals. Not aware of a universal World accepted standard of drug approval, certainly would make sense cost wise for the global return. But guess there is money in running trials as well.
Any doctor can prescribe it off-label if they wish, although they might be hesitant in the non-insomniac population due to the relatively high cost (>50p per 2mg dose)