Twenty-eight days of supplementation with the Melotime-branded ingredient from India-based Nutriventia was also associated with improvements in subjective sleep quality and psychological wellbeing, according to findings published in Clocks & Sleep.
Commenting on the new study, Dr. Shefali Thanawala, AVP, Medical Science & Research, Nutriventia and lead author on the paper, stated: “We developed Melotime to address the physiology of overnight sleep -- not just sleep onset. 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 [pharmacokinetic] 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.”
Sleep supplements
Consumers are increasingly aware of the detrimental effects of not getting enough sleep, from impaired cognitive function to weight gain.
Data from the Lumina Intelligence showed that “sleep” was the top health goal for adults aged 18-54 in the U.S. and Europe. Over 55s ranked it number 2, behind longevity.
This has led to an explosion in the sleep aid category, which was dominated for years by OTC products. However, market data indicates that consumers are increasingly seeking “natural” alternatives. This has led to some companies like P&G launching dietary supplement formulations under its OTC ZzzQuil brand.
Study details
The new randomized, double-blind, placebo-controlled study evaluated the effects of nightly Melotime (4.44 mg SR, equivalent to 2 mg melatonin) versus placebo in 59 healthy adults aged 30–60 experiencing poor sleep quality over a 28-day treatment period.
Objective sleep parameters were measured using overnight polysomnography (PSG), while subjective sleep quality and wellbeing were assessed using the Pittsburgh Sleep Quality Index (PSQI) and validated psychological wellbeing questionnaires (WHO-5 Well-Being Index).
Results showed that sleep efficiency (as measured by PSG) was significantly improved by the end of the study, compared to placebo, while the Melotime group also spent more total sleep time over the study period, compared to a decline in the placebo group. This 6.5% increase in total sleep time from the start until the end of the study corresponded to approximately six and half hours of more sleep.
“The improvement in sleep efficiency observed with melatonin-SR reflects better sleep consolidation and maintenance in individuals experiencing poor sleep quality and can be considered clinically relevant,” wrote the researchers. “Collectively, these findings suggest that melatonin-SR may contribute to meaningful improvements in objective sleep outcomes in adults with poor sleep quality.”
The melatonin supplement group also fell asleep approximately 10 minutes faster on average after 28 days, while the placebo group saw an increase in their time to fall asleep by over 15 minutes. The Melotime group also stayed asleep better, with fewer night-time awakenings, compared to placebo.
Participants self-reported meaningful improvements in sleep quality as early as day seven, and gains in psychological wellbeing from Day 14, suggesting both fast onset of perceived benefit and sustained impact.
“For formulators and brand owners, this study changes the conversation,” commented Anand Godbole, Senior Vice President, Commercial & Product Strategy, Nutriventia. “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.”
Nutriventia recently expanded its portfolio with Melotime N, melatonin naturally sourced from St. John’s wort (Hypericum perforatum L.).
Source: Clocks & Sleep. 2026, 8(2), 31; doi: 10.3390/clockssleep8020031. “Efficacy and Safety of Sustained-Release Melatonin Capsules (2 mg) in Healthy Adults with Poor Sleep Quality: A Randomized, Double-Blind, Placebo-Controlled Trial”. Authors: S. Thanawala, et al.
