New Polysomnography-Backed Trial Shows Sustained-Release Melatonin Improves Sleep at 2 mg Dose

Nutriventia has published new clinical trial results for Melotime, its sustained-release melatonin ingredient, in the peer-reviewed journal Clocks & Sleep, reporting statistically significant improvements in sleep efficiency, total sleep time, and other objective sleep measures at a comparatively a 2 mg nightly dose.¹^,2

For an ingredient category where clinical substantiation frequently relies on subjective sleep diaries or questionnaires alone, the use of polysomnography—considered a gold-standard, laboratory-based method for objectively recording sleep—as the trial's primary outcome measure is a meaningful methodological detail for manufacturers evaluating melatonin ingredient claims.

"We developed Melotime to address the physiology of overnight sleep, not just sleep onset," said Shefali Thanawala, PhD, study lead author and vice president of medical science and research at Nutriventia. "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."

What Did the Clinical Trial Actually Measure?

The randomized, double-blind, placebo-controlled trial enrolled 59 adults ages 30 to 60 who reported poor sleep quality, randomly assigning them to receive either the sustained-release melatonin formulation, delivering an equivalent of 2 mg of melatonin, or a matching placebo nightly for 28 days.¹

Objective sleep parameters were assessed using overnight polysomnography, while subjective outcomes were tracked using the Pittsburgh Sleep Quality Index and the World Health Organization-5 Well-Being Index, both validated instruments in sleep and psychological research.

According to Thanawala, "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 wellbeing."

The study also reported no clinically significant safety concerns over the 28-day period.

How Common Is Poor Sleep, and What Are Current Options for Addressing It?

Sleep difficulty remains a widespread concern in the general population; a national health survey found that roughly 14.5% of adults reported trouble falling asleep most days or every day over the prior month, with prevalence varying by age and demographic group.³ Over-the-counter melatonin remains one of the most commonly used sleep aids, but immediate-release formulations are metabolized quickly, which researchers have pointed to as a limitation when addressing sleep maintenance during the later hours of the night rather than sleep onset alone.

Sustained-release formulations are intended to address that specific gap, though clinical evidence directly comparing objective, polysomnography-verified outcomes between sustained-release and immediate-release melatonin remains limited across the category.

What Should Formulators Take Away From This Data?

The use of polysomnography as a primary endpoint distinguishes this trial from much of the existing melatonin literature, which has often relied on subjective sleep diaries alone.

Anand Godbole, senior vice president of commercial and product strategy at Nutriventia, framed the distinction directly for brand owners: " … PSG-validated evidence at a 2 mg dose, published in a peer-reviewed journal, is not a claim; it is a dossier." That said, a single 28-day trial in 59 participants, while methodologically stronger than many category studies, still represents an early stage of evidence relative to the long-term chronic use patterns common among melatonin consumers.

What Are the Limitations of This Study?

The trial's 28-day duration does not establish whether the observed benefits persist with longer-term nightly use, a relevant consideration given that melatonin is frequently used chronically rather than short-term.

The study population was also limited to adults with self-reported poor sleep quality rather than a clinically diagnosed insomnia population, which may affect how directly the findings generalize to individuals with diagnosed sleep disorders. Independent replication in a larger, more diverse population would strengthen confidence in the reported effect sizes.

References

1. Thanawala S, Abiraamasundari R, Shah R. Efficacy and safety of sustained-release melatonin capsules (2 mg) in healthy adults with poor sleep quality: a randomized, double-blind, placebo-controlled trial. Clocks Sleep. 2026;8(2):31. doi:10.3390/clockssleep8020031

2. Nutriventia. Nutriventia's Melotime shown effective at 2 mg: new published study. Nutriventia. July 2026. Accessed July 13, 2026. Press release provided via email.

3. Black LI, Vahratian A, Hoffman HJ. Sleep difficulties in adults: United States, 2020. NCHS Data Brief No. 436. National Center for Health Statistics; 2022.