Summary: A pharmacokinetic study evaluated a sustained-release melatonin formulation, Melotime, designed to support healthy sleep patterns. The study demonstrated that Melotime’s delivery system extends melatonin’s half-life, maintains plasma concentration for up to eight hours, and reduces the need for frequent dosing compared to immediate-release formulations.
Key Takeaways:
- Prolonged Melatonin Release: Melotime’s sustained-release formulation extends the half-life of melatonin to 5.10 hours, compared to 1.01 hours for immediate-release melatonin.
- Optimized Concentration Timing: The study found higher plasma melatonin levels in the delayed phase (4-8 hours), potentially improving overnight sleep support.
- Convenience and Efficacy: The formulation reduces the need for repeated dosing and avoids sharp peaks in melatonin concentration, offering balanced and consistent support for maintaining healthy sleep cycles.
Nutriventia, a developer of consumer-centric nutraceuticals, announced the results of a pharmacokinetic study evaluating its novel Melotime sustained-release melatonin designed to support healthy sleep patterns.
The study demonstrated the benefits of Nutriventia’s delivery technology, which addresses common limitations of traditional melatonin supplements, according to Dr Shefali Thanawala, head of medical science and research at Nutriventia, in a release.
The study compared the pharmacokinetics of Melotime, a 5 mg sustained-release melatonin capsule to a standard 5 mg immediate-release formulation.
Study Highlights:
- Optimized Peak Concentration: Melotime reported higher plasma concentration in the delayed phase from four to eight hours as compared to immediate-release melatonin.
- Extended Half-Life: The half-life of Melotime was extended to 5.10 hours, compared to 1.01 hours for immediate-release melatonin.
- Sustained Plasma Concentration: Melotime’s innovative formulation ensures prolonged melatonin levels in the bloodstream, potentially reducing the need for frequent dosing.
Study Design and Methodology
The open-label, cross-over study involved healthy men and women aged 18-45 who received either the sustained-release or immediate-release melatonin, followed by a seven-day washout period. The study measured key pharmacokinetic parameters—maximum concentration, time to reach optimized peak concentration, area under the curve, and elimination half-life.
Results showed that Melotime demonstrated prolonged melatonin release and extended half-life compared to the immediate-release formulation.
“Melotime’s sustained-release design is beneficial for bioactives like melatonin, which traditionally require repeated doses due to their short half-life,” says Thanawala in a release. “By maintaining melatonin levels over an extended period, Melotime can provide more convenient and effective support for managing sleep cycles naturally.”
Rajat Shah, director, adds in a release, “Further, by avoiding sharp peaks in melatonin concentration, which are common with immediate-release formulations, the study demonstrates that Melotime’s smooth, controlled release helps ensure melatonin levels remain balanced, especially during critical early morning hours, promoting safer and more consistent support for healthy sleep patterns.”
These statements have not been evaluated by the Food and Drug Administration. This ingredient is not intended to diagnose, treat, cure, or prevent any disease.
ID 171997973 © Kuprevich | Dreamstime.com
