Did a Melatonin Patent Inspire Current Dose Confusion?

Published: July 14, 2018, 9:16 p.m.

Yesterday\xa0I wrote about melatonin, mentioning that most drugstore melatonin supplements were 10x or more the recommended dose. A commenter on Facebook pointed me to an interesting explanation of why.

Dr. Richard Wurtman, an MIT scientist who helped discover melatonin\u2019s role in the body and pioneer its use as a sleep aid,\xa0writes:

MIT was so excited about our research team\u2019s melatonin-sleep connection discovery that they decided to patent the use of reasonable doses of melatonin\u2014up to 1 mg\u2014for promoting sleep.

But they made a big mistake. They assumed that the FDA would want to regulate the hormone and its use as a sleep therapy. They also thought the FDA wouldn\u2019t allow companies to sell melatonin in doses 3-times, 10-times, even 15-times more than what\u2019s necessary to promote sound sleep.

Much to MIT\u2019s surprise, however, the FDA took a pass on melatonin. At that time, the FDA was focusing on other issues, like nicotine addiction, and they may have felt they had bigger fish to fry.

Also, the FDA knew that the research on melatonin showed it to be non-toxic, even at extremely high doses, so they probably weren\u2019t too worried about how consumers might use it. In the end, and as a way of getting melatonin on to the market, the FDA chose to label it a dietary supplement, which does not require FDA regulation. Clearly, this was wrong because melatonin is a hormone, not a dietary supplement.

Quickly, supplement manufacturers saw the huge potential in selling melatonin to promote good sleep. After all, millions of Americans struggled to get to sleep and stay asleep, and were desperate for safe alternatives to anti-anxiety medicines and sleeping pills that rarely worked well and came with plenty of side effects.

Also, manufacturers must have realized that they could avoid paying royalties to MIT for melatonin doses over the 1 mg measure. So, they produced doses of 3 mg, 5 mg, 10 mg and more! Their thinking\u2013like so much else in our American society\u2013was likely, \u201cbigger is better!\u201d But, they couldn\u2019t be more wrong.

So he\u2019s saying that\u2026in order to get around a patent on using the correct dose of melatonin\u2026supplement manufacturers\u2026used the wrong dose of melatonin? I enjoy collecting stories of\xa0all the\xa0crazy\xa0perversities\xa0created by our current pharmaceutical system, but this one really takes the cake.