The Efficacy of Prosomnial TM Compared to a Synthetic Comparator for Melatonin Absorption and a Pilot for Sleep Efficacy—A Randomised, Double-Blind, Active-Controlled, Cross-Over Study

Abstract

Background : Recent findings have identified pistachios as a rich source of plant-derived melatonin, prompting the development of Prosomnial TM , a unique natural melatonin supplement. This randomised, double-blind, active-controlled, cross-over pilot study aimed to evaluate the absorption and short-term effects on sleep of Prosomnial TM compared to synthetic melatonin. Methods : Twenty-six healthy adults (mean age 31.2 ± 7.5 years) with self-reported difficulty initiating sleep participated. Each received both formulations in a cross-over design with a 14-day washout. Pharmacokinetic parameters (C max , T max , AUC 0 - 2h ) were assessed after a single dose. Sleep outcomes, including latency, duration, quality, and feeling rested, were recorded using validated daily sleep diaries over 7-day supplementation periods. Results : Prosomnial TM was shown to have comparable absorption to synthetic melatonin in AUC 0 - 2h , C max , and T max . Both interventions improved subjective sleep outcomes compared to baseline. Prosomnial TM significantly reduced sleep latency and improved total sleep time, sleep quality, and morning restfulness. No treatment-related adverse events were reported. Conclusion : Prosomnial TM demonstrated comparable melatonin absorption and sleep-promoting effects to synthetic melatonin, supporting its use as a natural alternative. Further studies with larger cohorts and objective sleep measures are recommended to confirm these findings and explore whether other plant-based compounds unique to Prosomnial TM may contribute additional effects.