Cooper Complete Melatonin Prolonged Release 3 mg

Our assessment

The evidence shows that this product is designed to support sleep, but the available data does not include specific studies or adverse event reports for the melatonin ingredient itself. Our assessment is that while melatonin is a common supplement for sleep, you should be cautious because the safety and efficacy data provided here is limited to other ingredients. Data not available for melatonin-specific studies from the provided list.

How it works

Think of the active ingredient, melatonin, as a sleep regulator — it helps signal to your body that it is time to rest. The prolonged release formulation is intended to provide a steady supply throughout the night. However, the only mechanistic data provided here is for Calcium, which supports bone mineralization and neuromuscular relaxation [NIH ODS]. Data not available for melatonin’s specific mechanism from the provided sources.

Safety profile

FDA received a total of 592,059 adverse event reports across all supplements, but specific report counts for this product or melatonin are not available [FDA data]. For the ingredient Calcium, high intakes can cause constipation, nausea, weight loss, extreme tiredness, abnormal heart rhythms, and a high risk of death from heart disease [NIH ODS]. Calcium can also reduce absorption of medications like bisphosphonates, tetracycline antibiotics, and levothyroxine [NIH ODS]. Data not available for melatonin-specific side effects from the provided FDA data.

Our recommendation

We recommend starting with the lowest effective dose for sleep support, but since data on this specific product’s effects are not provided, you should consult your doctor before use. Be aware that the Calcium in this product may interact with prescription medications [NIH ODS]. Do not exceed the labeled dose. Data not available for a specific dose recommendation from the provided sources.

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