Nutriventia’s Melotime Sustained-Release Melatonin Supports Sleep at 2 mg Dose: Study

Ingredient manufacturer Nutriventia announced the results of a randomized, double-blind, placebo-controlled clinical study demonstrating that its sustained-release melatonin ingredient Melotime supported significant improvements in sleep quality and overall well-being measures in adults experiencing poor sleep, at a two-milligram nightly dose. The findings were published in Clocks & Sleep.

The study evaluated the effects of a nightly 4.44 mg dose of the sustained-release formulation, equivalent to 2 mg melatonin, versus a placebo in 59 healthy adults between the ages of 30 and 60 who reported poor sleep quality at baseline. The treatment period lasted 28 days.

“We developed Melotime to address the physiology of overnight sleep, not just sleep onset,” said Shefali Thanawala, AVP of medical science and research at Nutriventia. “The premise was simple: if melatonin is metabolized too quickly, the benefit is front-loaded and the second half of the night is left unprotected. Our sustained-release design was built to correct that problem. After our randomized crossover PK study confirmed a sustained-release profile over immediate-release melatonin, we were encouraged to validate this in a rigorous placebo-controlled trial in adults with disturbed sleep.”

According to Thanawala, a defining strength of this study is the use of polysomnography, a tool for sleep assessment, as the primary efficacy measure across the treatment period.

“The results were unambiguous; Melotime produced statistically significant improvements in sleep efficiency, total sleep time, sleep onset latency, and wake after sleep onset, alongside meaningful gains in subjective sleep quality and psychological well-being.”

Study Details

In the polysomnography assessment, researchers observed statistically significant improvements in sleep efficiency by day 28, compared to the placebo group.

The treatment group gained measurably more total sleep time over the study period while placebo participants saw a net decline; the divergence widened over the 28-day window.

Those who took the supplement also fell asleep significantly faster than placebo participants, who saw sleep onset latency worsen over the same period.

The treatment group also saw fewer nighttime awakenings, suggesting more consolidated, uninterrupted overnight sleep.

Participants also reported meaningful improvements in sleep quality as early as day 7, and gains in psychological well-being by day 14.

No significant safety concerns were observed across the full treatment period.

“For formulators and brand owners, this study changes the conversation,” said Anand Godbole, senior vice president of commercial and product strategy. “PSG validated evidence at a 2 mg dose, published in a peer-reviewed journal, is not a claim; it is a dossier. Melotime brings that scientific credibility together with Clean Label Project certification and a first-to-market gummy-ready format, giving our customers the rare combination of evidence depth and application versatility they need to win on shelf.”

Introducing Melotime N

Nutriventia expanded its Melotime portfolio with Melotime N, a melatonin naturally sourced from St. John’s wort (Hypericum perforatum L.),, delivered via the same dose-independent release profile and formulated with the same natural excipients for a plant-based alternative. It is optimized at 300 microns, supporting uniform blending and batch-to-batch consistency.

“Taking a cue from the high consumer interest in natural plant-derived supplement sources, we have created Melotime N, a sustained-release melatonin using natural plant-derived melatonin and natural plant-derived excipients that matches our clinically validated Melotime release profile to provide even more choice and flexibility to our customers.”