Previously submitted to: JMIR Mental Health (no longer under consideration since Apr 26, 2025)
Date Submitted: Apr 24, 2025
Open Peer Review Period: Apr 26, 2025 - Apr 26, 2025
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Effect of a Saffron Extract on Sleep Quality in Adults with Moderate Insomnia: A Decentralized, Web-Based, Randomized, Double-blind, Placebo-Controlled Trial
ABSTRACT
Background:
Sleep disturbances are highly prevalent and associated with an increased risk of mental and physical health disorders. Given the limitations of pharmacological treatments, natural interventions such as saffron extract have attracted growing interest for their potential to improve sleep and stress-related outcomes.
Objective:
To examine the effect of a standardized saffron extract (Safr’Inside™) on sleep quality, insomnia symptoms, stress, and psychological well-being in adults with moderate insomnia.
Methods:
This nationwide, web-based, 3-arm, randomized, double-blind, placebo-controlled trial was conducted across Germany with 165 adults reporting moderate insomnia. A total of 158 participants completed the baseline survey and were included in the intention-to-treat (ITT) analysis; 147 participants completed the study per protocol. Participants received a daily capsule containing either 30 mg saffron extract, 20 mg saffron extract, or placebo (maltodextrin) for 4 weeks. The primary outcome was the change in insomnia symptoms assessed using 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-BREF (WHOQOL-BREF). Analyses followed an intention-to-treat approach, supported by per-protocol confirmation. Participants took the capsules independently at home. Email reminders were sent when questionnaires were not completed. No scheduled personal contact took place.
Results:
Compared to placebo, saffron extract significantly improved insomnia symptoms (AIS), with the most pronounced effects observed for sleep onset and sleep duration (P > .05). Sleep quality (SQS) improved significantly after 3 weeks (P < .05 for 30 mg; P < .01 for 20 mg). Both saffron doses reduced perceived stress (PSS) more than placebo (P = .01). Psychological symptoms (PHQ-4) improved significantly in the 30 mg group compared to placebo (P < .05), while no significant group differences were observed for ESS, PANAS, or WHOQOL-BREF. No serious adverse events were reported.
Conclusions:
Supplementation with 20 or 30 mg of saffron extract for 4 weeks may reduce insomnia symptoms and perceived stress in adults with moderate sleep disturbances. The observed improvement in psychological well-being with the 30 mg dose is consistent with previously reported effects. Future research should assess longer interventions, reliable objective sleep measures, and the complementary effects of saffron on stress and sleep. Clinical Trial: Trial name: Effect of a saffron extract on sleep parameters in healthy adults with poor sleep: a randomized, double blind, 3 arm, placebo-controlled clinical study. DRKS-ID: DRKS00033435 URL: https://drks.de/search/en/trial/DRKS00033435
Citation
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