Puritan's Pride Premium Super Strength Melatonin 10 mg

Our assessment

The evidence shows that this product contains 10 mg of melatonin, which is a very high dose. For reference, most adults only need 0.5 to 5 mg for sleep support. Data on the specific ingredient, calcium, is provided here, but the product label lists melatonin as the active ingredient. Our assessment is that you should be cautious with this dose, as it exceeds typical recommendations.

How it works

While the product is melatonin, the data provided describes calcium. Calcium supports bone mineralization and neuromuscular relaxation [NIH ODS]. Think of it as a key building block for your skeleton and a regulator for muscle and nerve function. However, this mechanism applies to calcium, not melatonin, which works differently in the brain to regulate sleep-wake cycles.

Safety profile

FDA received 592,059 total adverse event reports across all supplements [FDA data]. For calcium specifically, high intakes may increase the risk of heart disease and prostate cancer [NIH ODS]. High levels in the blood and urine can cause poor muscle tone, poor kidney function, constipation, nausea, weight loss, extreme tiredness, frequent urination, abnormal heart rhythms, and a high risk of death from heart disease [NIH ODS]. Calcium also reduces absorption of several medications including bisphosphonates, tetracycline antibiotics, fluoroquinolone antibiotics, levothyroxine, and phenytoin [NIH ODS]. Data for melatonin-specific side effects is not available in the provided data.

Our recommendation

Start with a much lower melatonin dose, typically 0.5 to 3 mg, as 10 mg is considered a super strength dose and may cause next-day drowsiness. The data on calcium interactions is important if you take any of the listed medications. For melatonin-specific safety and efficacy data, the information provided is limited to calcium. Choose a lower strength product if you are new to melatonin.

Supplement labels contain several key sections regulated by the FDA:

• Serving Size — The recommended amount per dose. Always check this — some products require multiple capsules per serving.
• Amount Per Serving — Shows the quantity of each nutrient in the product, typically in IU (International Units), mg (milligrams), or mcg (micrograms).
• % Daily Value (%DV) — Indicates how much a nutrient in a serving contributes to a daily diet. 5% DV or less is low; 20% DV or more is high.
• Other Ingredients — Lists inactive ingredients like fillers, binders, and capsule materials (e.g., gelatin, cellulose, magnesium stearate).
• Suggested Use — The manufacturer's recommended directions for taking the supplement, including timing and dosage.

Source: FDA Dietary Supplement Labeling Guide