How to effectively and safely dose melatonin is an often-asked question, largely due to the abundance of misinformation available on the internet. One of the reasons for the misinformation is that melatonin is classified as a dietary supplement. Because the FDA doesn’t regulate dietary supplements, the onus is on supplement makers to acquire third party certification of a product’s label. Poor quality control in many over the counter products, including melatonin, leads to an inconsistency between stated versus actual dosage.
A 2017 study of 31 different over the counter melatonin preparations found that, when analyzed, the dosage of 71% of the products didn’t match what was stated on the label. Melatonin content varied from −83% to +478% of labeled melatonin, and 70% had a melatonin concentration that was less than 10% of what was claimed. 1 In 2015, the New York State Attorney General’s office conducted an investigation that revealed four out of five products pulled from the shelves of major retailers such as GNC, Target, Walgreens and Walmart didn’t contain any of the herbs listed on the supplement’s label. 2
Pharmaceutical grade supplements (also referred to as “physician grade” and “provider grade”) are only available through a board certified physician/provider. These products have been vetted by a third party lab providing unbiased assurance of quality control, ensuring that no unlisted additives are present, and that dosages claimed match analyzed dosages. Once standards are met, the products bears the seal of approval from the certifier.
Because of this inconsistency in OTC stated dosages, patients will often claim that they used melatonin in the past and “it didn’t work.” When you hear this from a patient ask where the product came from, what was the dosage, and whether it was a fast acting or timed-release product. Very likely your patient won’t be able to answer these questions and decided that melatonin is not for them. Reassuring them that they may have received a much lower or higher dose than expected may make them feel better about trying melatonin again.
The jury is out as to whether melatonin has somnogenic or sleep-promoting properties, or if it merely sends a signal to the suprachiasmatic nucleus to phase-advance the diurnal rhythm. Either way, melatonin has been shown to have sleep promoting and sustaining effects.
What dosage to offer your patients is another frequently asked question. First assess whether your patient is struggling with falling asleep or staying asleep, or both. Fast acting formulations for sleep are usually in the .3-5mg range, with low dosages such as .3 and .5mg shown to be as effective as higher dosages in reducing sleep latency and age-related insomnia. 3 Fast acting products are taken anywhere from 30-90 min before desired bed time. Chewable, liquid and liposomal formulations seem to be faster acting as they bypass the digestive tract. Sustained or time- released formulas that release over a 3-5 hour time frame tend to be higher doses, starting in the 2-3mg range. These are taken at bedtime and are fine to take in capsule or tablet form. Some patients will need help with both falling and staying asleep and will need both. Keep in mind melatonin’s temperature lowering effects, making it a great choice for menopausal women and anyone experiencing night sweats.
Starting with a low dose and watching for effects before working up to a higher dose is a good strategy. Keep in mind there may be some initial variability in response rates depending on one's medical history. A 2014 study on postmenopausal women found that 64% of subjects reported immediate improvement in sleep, but 35% claimed no significant improvement in the first month of supplementation. The latter group was comprised of women who had previously used hypnotic drugs, reporting significant improvement with melatonin usage after 6-8 weeks of administration. 4
