Written by Tabish Mehraj, PhD. In this study, among 150 completers, saffron extract led to a greater reduction in insomnia symptoms (AIS) compared to placebo (between-group adjusted mean difference β =− 0.95 [95 % CI: − 1.79, − 0.11], P < .05). Sleep quality (SQS) improved significantly after 3 weeks (30 mg vs placebo: β =0.82 [95 % CI: 0.22, 1.41], P =004; 20 mg vs placebo: β =1.02 [0.43, 1.62], P <.001). Perceived stress (PSS) was significantly reduced with 30 mg or 20 mg saffron extract compared to placebo (30 mg vs placebo: β =− 1.87 [95 % CI: − 3.23, − 0.] P =.01; 20 mg vs placebo: β =− 1.89 [95 % CI: − 3.22, − 0.52], P =04).

Insomnia is a common sleep disorder associated with impaired physical and mental health. Poor sleep has been associated with a 1.74-fold higher risk of cardiovascular diseases. Due to the limitations and adverse effects of conventional pharmacologic therapies, interest has grown in natural interventions such as saffron (Crocus sativus). This study evaluated the efficacy and safety of two doses of a standardized saffron extract (Safr’Inside™) on sleep quality, insomnia severity, stress, and psychological well-being in adults with moderate insomnia. Saffron (Crocus sativus) has emerged as a promising candidate due to its bioactive compounds, crocin and safranal, which have shown potential to modulate neurotransmitter activity, reduce oxidative stress, and improve mood and sleep quality. These effects are mainly due to Saffron’s impact on serotonin reuptake, GABA receptor modulation, and its antioxidant, anti-inflammatory, neuroprotective, and HPA-axis-regulating properties.

In this 4-week randomized, decentralized, double-blind, placebo-controlled trial, 165 adults (18–65 years) with moderate insomnia were grouped to receive 20 mg/day saffron extract (n=55), 30 mg/day saffron extract (n=55), or placebo (n=) in the evening 60 minutes before bedtime. The main parameters assessed were changes in the Athens Insomnia Scale (AIS) score. Other outcomes are sleep quality (Single-item Sleep Quality Scale SQS), perceived stress (PSS), anxiety/depression (PHQ-4), daytime sleepiness (ESS), affect (PANAS), quality of life (WHOQOL-BREF), and adverse events. Analyses were conducted using intention-to-treat and confirmed by per-protocol analyses.

Results/Main Findings

• Both doses of saffron significantly improved the symptoms of sleep quality and stress as compared with placebo over 4 weeks, with benefits becoming apparent after 3 weeks.
• Combined saffron groups showed significantly greater improvement than placebo (β = −0.95; 95% CI: −1.79 to −0.11; P = .027). Mean AIS reduction: 30 mg: −1.96 points, 20 mg: −1.54 points, Placebo: −0.71 .
• Sleep quality (SQS): Significant improvements were observed after 3 weeks, persisting through week 4. 30 mg vs placebo: β = 0.82 (95% CI: 0.22–1.41; P = .004), 20 mg vs placebo: β = 1.02 (95% CI: 0.43–1.62; P < .001)
• Perceived stress (PSS): Both saffron doses significantly reduced stress compared with placebo. 30 mg: β = −1.87 (95% CI: −3.23 to −0.53; P = .012), 20 mg: β = −1.89 (95% CI: −3.22 to −0.52; P = .043)
• Psychological distress (PHQ-4): Significant improvement was observed only with 30 mg saffron. β = −0.79 (95% CI: −1.40 to −0.18; P = .034)

The strengths of the study are a large randomized controlled trial (165 participants), making it one of the largest saffron-insomnia studies to date. Randomized, double-blind, placebo-controlled design minimized bias. The inclusion of two saffron doses (20 mg and 30 mg) enabled a dose-response evaluation. Nationwide decentralized design improved recruitment, adherence, and participant retention. Both intention-to-treat and per-protocol analyses produced consistent findings. Multiple validated questionnaires were used to comprehensively assess sleep and psychological outcomes.

Despite various positive outcomes and a strong study, there are a few limitations, such as the fact that sleep outcomes were based solely on self-reported questionnaires, without objective measures such as polysomnography or actigraphy. Intervention duration was relatively short (4 weeks), limiting assessment of long-term efficacy. No physiological biomarkers (e.g., melatonin, cortisol, inflammatory markers) were measured to clarify mechanisms. Female predominant participants (77%) may limit generalizability to men. Most observed effects were small to moderate, reflecting modest clinical improvements. Minimal clinically important differences (MCIDs) have not been established for several outcome measures (AIS, SQS, and PSS), making clinical relevance difficult to interpret. Saffron may represent a safe adjunctive nutritional strategy for improving sleep health, although longer-term studies incorporating objective sleep measures are warranted.

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Posted August 5, 2026.

Dr. Tabish Mehraj is a pharmaceutical scientist with expertise in pharmaceutics, drug delivery, and formulation development. She earned her PhD in Pharmaceutical Sciences from the University of Mississippi, where her research focused on the formulation, optimization, and characterization of lipid-based nanocarriers for targeted liver delivery of antimalarial therapeutics. Dr. Mehraj has also served as an ORISE Fellow at the U.S. Food and Drug Administration (FDA), where she evaluated the effects of formulation and process design on the quality and performance of intravaginal drug delivery systems and developed bio-relevant in vitro drug release testing methods. She has teaching experience in pharmaceutical and life sciences courses and has authored peer-reviewed publications, book chapters, and conference presentations. Dr. Mehraj is an active member of the American Association of Pharmaceutical Scientists and has been recognized by honor societies including Rho Chi and Gamma Beta Phi.

References:

1. Schuster, J., Mundhenke, C., Nordsieck, H., Pouchieu, C., Pourtau, L., & Hahn, A. (2025). Effect of a saffron extract on sleep quality in adults with moderate insomnia: A decentralized, randomized, double-blind, placebo-controlled trial. Sleep medicine: X, 100147.