5

On Episode 515 of the Wellness Mama podcast, Dr. Michael J. Breus made the statement that melatonin is used for birth control in Europe:

Melatonin in Europe is used as a contraceptive. Let me say that one more time. Melatonin in Europe is used as birth control.

(Copied from the transcript at the bottom of the page, this statement happens around the 48:19 mark).

Assuming he's not just talking about self-medication, is melatonin prescribed and/or marketed as a contraceptive in Europe?

LShaver
  • 9,931
  • 6
  • 41
  • 73
  • 1
    Did you look at the wikipedia article on melatonin? It is quite extensive and describes that it is over the counter in the US but presciption only in the EU. It is used to treat insomnia. There is no mention for birth control anywhere. – quarague Jan 22 '22 at 16:47
  • 1
    @quarague melatonin is available otc in the EU as well. I've seen up to 5mg freely available in The Netherlands. – SQB Jan 23 '22 at 14:20
  • 1
    @quarague I've expanded the explanation at the beginning of my answer: EU-wide licensing of medicines is mostly optional, and all EU countries (and European countries outside the EU, of which there are plenty) also have their own systems for licensing and regulation. So the fact that an EU regulation makes it available by prescription for one purpose doesn't prevent a national regulation making it available over the counter, or for a different purpose. – IMSoP Jan 23 '22 at 18:43
  • 1
    You know someone is devoid of arguments when they say "X is true" and you wait for them to give evidence to back it up and they say "Let me say it again, X is true." – DJClayworth Jan 24 '22 at 20:11
  • 1
    As a general, rule you can safely assume that any claims made about "Europe" are wrong, simply because there is no such homogenous social entity as "Europe". – Jörg W Mittag Jan 27 '22 at 06:45

3 Answers3

15

"Europe" is rather larger and more diverse than Americans sometimes think - medical practice, and medicine availability, is different in the UK than in France, and different again in the Netherlands, and so on. As explained on the website of the European Medicines Agency:

While the majority of new, innovative medicines are evaluated by EMA and authorised by the European Commission in order to be marketed in the EU, most generic medicines and medicines available without a prescription are assessed and authorised at national level in the EU.

Aside from that, of course, about half of the countries geographically located in Europe are not members of the EU. That makes it hard to rule out that there is somewhere in Europe where it is prescribed or marketed as such, unless we can find a more specific claim - we would have to investigate its licensing in as many as 50 countries, depending on how you define "Europe", in order to conclusively prove the negative.

Searching the EMA website, I found two EU-wide registrations for melatonin:

  • Circadin, authorised in 2007 for treatment of insomnia in patients aged 55 years or over
  • Slenyto, authorised in 2018 for treatment of insomnia in children with Autism Spectrum Disorder or Smith-Magenis syndrome

There are some applications for treating other conditions, but none related to fertility.

Neither application mentions fertility problems as a known side-effect, although I did find the following in the Risk Management Plan Summary for Slenyto:

Important Potential Risk: Delay of sexual maturation and development

Evidence for Linking the Risk to the Medicine: The active substance is the hormone melatonin which regulates the reproductive process in seasonal but not in continuous breeders; however, it delays sexual development in the rat in a transient and reversible manner (Lang, 1986; Lang et al, 1984).

Risk Factors and Risk Groups: Children and adolescents that are between pre-pubertal to pubertal stages.

It recommends that this potential risk be monitored and studied further. The connection between melatonin and fertility therefore doesn't seem to be completely without basis, but the gap between that and active use as a contraceptive seems implausibly large.

Similarly, the UK National Health Service website has a page on melatonin describing its prescription for sleep disorders. In the Q&A section, it says:

Will it affect my fertility?

There's no firm evidence to suggest that taking melatonin will reduce fertility in either men or women.

But speak to a pharmacist or doctor if you're trying to get pregnant. They may want to review your treatment.

And:

Will it affect my contraception or HRT?

Melatonin does not affect how contraception works, including the combined pill and emergency contraception.

However, your levels of melatonin can increase when taking the combined pill or hormone replacement therapy (HRT).

Speak to a doctor or pharmacist before taking melatonin if this applies to you.

So, again, contraception is not even an expected side-effect, let alone an encouraged use.

IMSoP
  • 8,040
  • 5
  • 38
  • 38
  • Technically the UK isn't part of Europe any more. – Paul Johnson Jan 23 '22 at 07:59
  • 22
    The UK is still part of Europe, the geographic entity. – DJClayworth Jan 23 '22 at 08:15
  • 1
    @DJClayworth: I would quibble with that (No island is part of a continent, by definition, according to my Year 8 Geography teacher.) but my definition isn't important. What did Breus mean? If they had one or two countries in mind, this isn't an answer. – Oddthinking Jan 24 '22 at 07:31
  • 13
    @Oddthinking: The definition of continents can be a bit fuzzy, but I doubt that your Year 8 Geography teacher had the British Isles in mind when they taught you that. The British Isles are without doubt located on the European continental shelf (which is an important defining property of continents), and they weren't even separated from the mainland only 8,000 years ago. – Schmuddi Jan 24 '22 at 08:59
  • 1
    @Oddthinking As I say in the answer, there could be as many as 50 countries we could examine before finding one that matched the claim; are you really expecting an answer to examine every single one? If you think the question can't be answered without additional information about the claim, that should be a comment (and close-vote) on the question, not this answer. – IMSoP Jan 24 '22 at 09:14
  • The 'logic' in use here for this theory could use an update? [Voordouw: "Melatonin and melatonin-progestin combinations alter pituitary-ovarian function in women and can inhibit ovulation"](https://doi.org/10.1210/jcem.74.1.1727807) or [R.E. Silman: "Melatonin: a contraceptive for the nineties"](https://doi.org/10.1016/0028-2243(93)90099-X) There were a few trials into making this usable reliably. – LangLаngС Jan 24 '22 at 15:32
  • @LangLаngС Interesting. I don't have access to the first paper, but the second refers to Stage III trials; it would be interesting to find out the outcome of those. The only direct lead is to a Dutch company called "AMR Pharm Holland BV". – IMSoP Jan 24 '22 at 16:10
  • IDK. Seems to have led nowhere. Although it was shown to work in cats [F. Gimeneza et al.: "Suppression of estrus in cats with melatonin implants"](https://doi.org/10.1016/j.theriogenology.2009.04.004) Hormones are bitchy things manipulate. Exogenous melatonin is even contraindicated for (other) contraceptives since estrogens influence CYP1A1 and CYP1A2 and thus mela would go way too high. AFAIK there is still 'not enough clinical data' to gauge the effects properly, as the official position, one way or the other re: pregnancy or contraceptive. – LangLаngС Jan 24 '22 at 16:21
  • Apart from official guidelines, [this](https://www.frontiersin.org/articles/10.3389/fendo.2020.00085/full) is the most recent summary known to me.(Of note, the countless articles floating that say in effect 'mela makes infertile' as well as 'mela improves all outcomes if pregnancy is wanted'! 'Fertility doctors describing it just as straight as 'antireproductive? Austrian first example gg showed me. Hilarious, but complicated ;) – LangLаngС Jan 24 '22 at 16:41
  • @PaulJohnson There are just too many definitions of the concept "Europe". For example, the **European** Broadcasting Union also includes several African and Asian countries -- not to mention that their most famous international product, the Eurovision Song Contest, now has Australia participating! – Hagen von Eitzen Jan 29 '22 at 18:30
  • @Oddthinking further, continental definitions have a cultural component; there's little else justifying a distinction between Europe and Asia. Japanese culture is surely Asian, just as British culture is European. – phoog Feb 10 '22 at 12:24
  • @phoog: Hence "quibble", "my definition isn't important" and a reference to my source. – Oddthinking Feb 10 '22 at 14:18
  • To repeat: if anyone thinks the definition of "Europe" is relevant, please vote to close the question as unclear, and stop commenting on this answer in particular. It is essentially impossible for *any* answer to cover every possible interpretation. (What if someone discovered it was used that way in Turkey or Russia - would that answer the question or not?) – IMSoP Feb 10 '22 at 14:36
7

Melatonin has certainly been tested in contraceptive pills in Europe, as the Washington Post (1995) reports:

Now Applied Medical Research Ltd., a fledgling drug company in Fairfax, hopes to change that by winning Food and Drug Administration approval to sell a melatonin-based prescription birth control pill, called B-Oval.
[...]
The firm's headquarters are a few somewhat tattered rooms in an office building on Chain Bridge Road. The company has only a handful of employees in the United States, who handle relations with the FDA and are attempting to organize a sale of stock to the public. Most of its research takes place in the Netherlands, where it employs 15 people to experiment with new combinations, oversee trials and manufacture enough of the drug for testing.
[...]
To date, B-Oval has been tested on more than 1,000 women in Europe.

To clarify, the pill was like existing birth control pills, but replaced estrogen with melatonin, while still having progestin in it.

There's the study Melatonin and melatonin-progestin combinations alter pituitary-ovarian function in women and can inhibit ovulation (1992). (Not sure if this is B-Oval but the details match. I couldn't read the full article.)

Did any of this lead anywhere beyond hypotheses and research? Not that I've discovered. I can't find anywhere selling any type of melatonin birth control, and the most recent article I can find about B-Oval (2006) says it hadn't launched yet due to lacking "the necessary finance".

Laurel
  • 30,040
  • 9
  • 132
  • 118
  • 2
    Pure mela pills were also tested, hi-dose-no-worky in women. But how about integrating the other links _I offered_ on the other answer? Often very aptly named, high quality, wider range in application and pub dates, should be in an answer. Comments tend to disappear. – LangLаngС Jan 25 '22 at 09:21
1

Not in Sweden, Melatonin is used for sleep problems.

This (pdf) Melatonin leaflet mentions

Women of childbearing potential should use contraception during treatment. However, Melatonin Orifarm may be affected by certain contraceptives (see section “Other medicines and Melatonin Orifarm”), discuss the choice of contraceptive with your doctor. Melatonin can cause drowsiness and impaired attention for several hours after ingestion.

And 1177, the official site for health information says:

Melatonin The active substance melatonin can work if you have difficulty falling asleep, wake up often and have difficulty falling asleep again or during jet lag. There is no risk of addiction, but the drug should only be used for a short time.

Side effects It is uncommon to get side effects from melatonin, but some may become tired and drowsy the next day. Some may have migraines, dizziness, dry mouth, abdominal pain or constipation.

Rsf
  • 2,844
  • 1
  • 12
  • 20