Effect of a saffron extract on sleep quality in adults with moderate insomnia: A decentralized, randomized, double-blind, placebo-controlled trial.

Aim: Natural interventions for sleep disturbances, such as saffron extract, are gaining scientific and clinical interest. This 3-arm, randomized, double-blind, placebo-controlled trial examined the effect of a standardized saffron extract (Safr'Inside™) on sleep, stress, and other associated psychological outcomes in 165 adults reporting moderate insomnia. Methods: Participants received 30 mg, 20 mg saffron extract, or placebo for 4 weeks. The primary endpoint was the change in insomnia symptoms (Athens Insomnia Scale, AIS). Secondary outcomes were the Single-Item Sleep Quality Scale (SQS), Perceived Stress Scale (PSS), Patient Health Questionnaire-4 (PHQ-4), Positive and Negative Affect Schedule (PANAS), Epworth Sleepiness Scale (ESS), and World Health Organization Quality of Life (WHOQOL). Analyses followed an intention-to-treat (ITT) approach, with per-protocol (PP) confirmation. Results: Among 150 completers, saffron extract led to a greater reduction in insomnia symptoms (AIS) than the placebo (between-group adjusted mean difference Conclusions: Four weeks of 20 or 30 mg saffron extract may reduce insomnia and stress in middle-aged adults. Future research should assess longer interventions and explore which subgroups benefit most from saffron extract.