Details
| Original language | English |
|---|---|
| Article number | 100147 |
| Journal | Sleep Medicine: X |
| Volume | 10 |
| Early online date | 9 Jul 2025 |
| Publication status | Published - 15 Dec 2025 |
Abstract
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 β = −0.95 [95 % CI: −1.79, −0.11], P < .05). In secondary analyses, sleep quality (SQS) improved significantly after 3 weeks and was sustained at week 4 in both saffron groups compared to placebo (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, −0.53], P = .01; 20 mg vs placebo: β = −1.89 [95 % CI: −3.22, −0.52], P = .04). Some improvement in psychological symptoms (PHQ-4) was also observed with 30 mg saffron extract compared to placebo (β = −0.79 [−1.40, −0.18], P = .03). All other measures showed no significant differences. No serious adverse events occurred. 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.
Keywords
- Athens insomnia scale, Decentralized trial, Insomnia, Mental health, Randomized controlled trial, Saffron extract, Sleep
ASJC Scopus subject areas
- Medicine(all)
- General Medicine
Sustainable Development Goals
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In: Sleep Medicine: X, Vol. 10, 100147, 15.12.2025.
Research output: Contribution to journal › Article › Research › peer review
}
TY - JOUR
T1 - Effect of a saffron extract on sleep quality in adults with moderate insomnia
T2 - A decentralized, randomized, double-blind, placebo-controlled trial
AU - Schuster, Julius
AU - Mundhenke, Christin
AU - Nordsieck, Hannah
AU - Pouchieu, Camille
AU - Pourtau, Line
AU - Hahn, Andreas
N1 - Publisher Copyright: © 2025 The Authors
PY - 2025/12/15
Y1 - 2025/12/15
N2 - 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 β = −0.95 [95 % CI: −1.79, −0.11], P < .05). In secondary analyses, sleep quality (SQS) improved significantly after 3 weeks and was sustained at week 4 in both saffron groups compared to placebo (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, −0.53], P = .01; 20 mg vs placebo: β = −1.89 [95 % CI: −3.22, −0.52], P = .04). Some improvement in psychological symptoms (PHQ-4) was also observed with 30 mg saffron extract compared to placebo (β = −0.79 [−1.40, −0.18], P = .03). All other measures showed no significant differences. No serious adverse events occurred. 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.
AB - 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 β = −0.95 [95 % CI: −1.79, −0.11], P < .05). In secondary analyses, sleep quality (SQS) improved significantly after 3 weeks and was sustained at week 4 in both saffron groups compared to placebo (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, −0.53], P = .01; 20 mg vs placebo: β = −1.89 [95 % CI: −3.22, −0.52], P = .04). Some improvement in psychological symptoms (PHQ-4) was also observed with 30 mg saffron extract compared to placebo (β = −0.79 [−1.40, −0.18], P = .03). All other measures showed no significant differences. No serious adverse events occurred. 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.
KW - Athens insomnia scale
KW - Decentralized trial
KW - Insomnia
KW - Mental health
KW - Randomized controlled trial
KW - Saffron extract
KW - Sleep
UR - http://www.scopus.com/inward/record.url?scp=105010296609&partnerID=8YFLogxK
U2 - 10.1016/j.sleepx.2025.100147
DO - 10.1016/j.sleepx.2025.100147
M3 - Article
AN - SCOPUS:105010296609
VL - 10
JO - Sleep Medicine: X
JF - Sleep Medicine: X
M1 - 100147
ER -