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Saffron and sleep quality: grade B

Moderate evidence. Direction: Benefit.

B ModerateIndustry-fundedShort-term only

Educational guidance, not medical advice

Why this grade

Rubric condition met: >=2 RCTs with mostly consistent results in adults with self-reported poor sleep; one meta-analysis across mixed populations

Four placebo-controlled trials in adults with poor sleep or sleep complaints (n=52 to 165, 4 weeks) reported better sleep scores than placebo with saffron extract; a fifth (n=66, 6 weeks, anxiety-related sleep complaints) reported within-group improvements the placebo group did not show, and a 2022 meta-analysis found a PSQI mean difference of -2.14 versus placebo. Most outcomes were questionnaires, but two trials used actigraphy or an EEG tracker. Four of the five trials were funded by or co-authored with extract makers, and the fifth did not state its funder in the records checked. A was not proposed because no trial ran beyond 6 weeks and independent replication is lacking; the meta-analysis pooled clinical groups.

How we grade evidence

Studies this grade rests on

EffectMixedNo effectSize shows participants (n)202020252030Meta-analysisRCTSchuster 2025, 2025: RCT, n = 165, result not recordedLopresti 2021, 2021: RCT, n = 120, result not recordedPachikian 2021, 2021: RCT, n = 66, result not recordedLopresti 2020, 2020: RCT, n = 63, result not recordedLang 2025, 2025: RCT, n = 52, result not recordedLian 2022, 2022: meta-analysis, n not recorded, result not recorded
each study this grade rests on, by publication year and design. Solid: effect versus the comparator; half-filled: mixed; hollow: no effect; dashed: result not recorded yet. Larger marks had more participants.
Show the numbers
StudyYearDesignParticipantsResult
Lopresti 20202020RCT63result not recorded
Pachikian 20212021RCT66result not recorded
Lopresti 20212021RCT120result not recorded
Lian 20222022meta-analysisnot recordedresult not recorded
Lang 20252025RCT52result not recorded
Schuster 20252025RCT165result not recorded

A standardised saffron extract improves subjective and objective sleep quality in healthy older adults with sleep complaints: results from the gut-sleep-brain axis randomised, double-blind, placebo-controlled pilot study.

Lang L, Ditton A, Stanescu A. A standardised saffron extract improves subjective and objective sleep quality in healthy older adults with sleep complaints: results from the gut-sleep-brain axis randomised, double-blind, placebo-controlled pilot study Food Funct, 2025. PMID 40762630

Result not recorded
Design
Randomized, placebo-controlled pilot trial (4 weeks)
Sample
n = 52
Population
Older adults aged 55-85 with self-reported sleep complaints
Funding
not stated in PubMed or Crossref record

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

Schuster J, Mundhenke C, Nordsieck H. Effect of a saffron extract on sleep quality in adults with moderate insomnia: A decentralized, randomized, double-blind, placebo-controlled trial Sleep Med X, 2025. PMID 40698027

Result not recorded
Design
Randomized, double-blind, placebo-controlled, 3-arm trial (4 weeks)
Sample
n = 165
Population
Adults reporting moderate insomnia
Funding
Financial support from Activ'Inside SAS (COI statement)

Effects of Saffron Extract on Sleep Quality: A Randomized Double-Blind Controlled Clinical Trial.

Pachikian BD, Copine S, Suchareau M. Effects of Saffron Extract on Sleep Quality: A Randomized Double-Blind Controlled Clinical Trial Nutrients, 2021. PMID 33925432

Result not recorded
Design
Randomized, double-blind, placebo-controlled trial (6 weeks)
Sample
n = 66
Population
Adults with mild to moderate sleep disorder associated with anxiety
Funding
Comercial Química Massó (Crossref funder)

An investigation into an evening intake of a saffron extract (affron®) on sleep quality, cortisol, and melatonin concentrations in adults with poor sleep: a randomised, double-blind, placebo-controlled, multi-dose study.

Lopresti AL, Smith SJ, Drummond PD. An investigation into an evening intake of a saffron extract (affron®) on sleep quality, cortisol, and melatonin concentrations in adults with poor sleep: a randomised, double-blind, placebo-controlled, multi-dose study Sleep Med, 2021. PMID 34438361

Result not recorded
Design
Randomized, double-blind, placebo-controlled, 3-arm trial (28 days)
Sample
n = 120
Population
Adults with unsatisfactory sleep
Funding
not stated in PubMed or Crossref record (full text not checked)

Effects of saffron on sleep quality in healthy adults with self-reported poor sleep: a randomized, double-blind, placebo-controlled trial.

Lopresti AL, Smith SJ, Metse AP. Effects of saffron on sleep quality in healthy adults with self-reported poor sleep: a randomized, double-blind, placebo-controlled trial J Clin Sleep Med, 2020. PMID 32056539

Result not recorded
Design
Randomized, double-blind, placebo-controlled trial (28 days)
Sample
n = 63
Population
Healthy adults aged 18-70 with self-reported sleep problems
Funding
Pharmactive Biotech Products SL (COI statement)

Effects of saffron supplementation on improving sleep quality: a meta-analysis of randomized controlled trials.

Lian J, Zhong Y, Li H. Effects of saffron supplementation on improving sleep quality: a meta-analysis of randomized controlled trials Sleep Med, 2022. PMID 35325766

Result not recorded
Design
Meta-analysis of randomized controlled trials
Population
Healthy adults, people with insomnia or type 2 diabetes, and people in methadone maintenance treatment
Funding
not stated in PubMed or Crossref record

Search and history

Search (): saffron[ti] AND (sleep[tiab] OR insomnia[tiab]) AND (meta-analysis[pt] OR systematic review[pt] OR randomized controlled trial[pt])

  • Graded B (proposed): Proposed in the monograph draft
  • B to B (approved): Editor sign-off November 13, 2026: grade matches the editor-approved final page