Effect of a Saffron Extract on Sleep Quality in Adults with Moderate Insomnia: A Decentralized, Randomized, Double-blind, Placebo-Controlled Trial
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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 TM ) on sleep, stress, and other associated psychological outcomes in 165 men and women reporting moderate insomnia.
Methods
Participants received a daily capsule containing 30 mg saffron extract, 20 mg saffron extract, or placebo (maltodextrin) for 4 weeks. The primary endpoint was the change in insomnia symptoms measured by the Athens Insomnia Scale (AIS). Secondary outcomes included 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
Compared to placebo, saffron extract significantly improved insomnia symptoms (AIS, P < .05), with the most pronounced effects on sleep onset and duration. Sleep quality (SQS) improved significantly after 3 weeks ( P < .05 for 30 mg, P < .01 for 20 mg). Both doses of saffron extract reduced perceived stress (PSS) more than placebo ( P = .01). Psychological symptoms (PHQ-4) improved significantly with 30 mg saffron compared to placebo ( P < .05), while all other measures showed no significant differences. No serious adverse events were reported.
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, reliable objective sleep measures, and complementary effects of saffron on stress and sleep.
