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Lemon balm and sleep quality: grade C

Limited evidence. Direction: Benefit.

C LimitedShort-term onlyIndustry-funded

Educational guidance, not medical advice

Why this grade

Rubric condition met: Small, short RCTs leaning toward benefit; two of three positive controlled trials industry-linked; one clinical trial null

A 2-week crossover in 30 adults with unrefreshing sleep, run by researchers employed by or consulting for the product maker Pharmextracta, found lower ISI scores than placebo (6.8 versus 9.7). The 3-week Relissa trial (product donated by Indena) found PSQI improvement, but the groups differed at baseline. An 8-week trial in chronic stable angina found less sleep disturbance, while a 12-week trial in type 2 diabetes found no difference in sleep quality. An open-label pilot supported by Naturex has no control group. Small, short, mostly industry-linked trials leaning toward benefit, with one null clinical trial, so C.

How we grade evidence

Studies this grade rests on

EffectMixedNo effectSize shows participants (n)2010201520202025RCTCrossover RCTOpen-label studyBano 2023, 2023: RCT, n = 100, result not recordedHaybar 2018, 2018: RCT, n = 80, result not recordedSafari 2023, 2023: RCT, n = 60, result not recordedDi 2024, 2024: crossover RCT, n = 30, result not recordedCases 2011, 2011: open-label study, n = 20, 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
Cases 20112011open-label study20result not recorded
Haybar 20182018RCT80result not recorded
Safari 20232023RCT60result not recorded
Bano 20232023RCT100result not recorded
Di 20242024crossover RCT30result not recorded

Pilot trial of Melissa officinalis L. leaf extract in the treatment of volunteers suffering from mild-to-moderate anxiety disorders and sleep disturbances.

Cases J, Ibarra A, Feuillère N. Pilot trial of Melissa officinalis L. leaf extract in the treatment of volunteers suffering from mild-to-moderate anxiety disorders and sleep disturbances Med J Nutrition Metab, 2011. PMID 22207903

Result not recorded
Design
Prospective, open-label pilot study, 15 days, no placebo
Sample
n = 20
Population
Stressed volunteers with mild-to-moderate anxiety and sleep disturbances
Funding
Financial assistance from Naturex (acknowledgments, full text)

Effects of Melissa officinalis Phytosome on Sleep Quality: Results of a Prospective, Double-Blind, Placebo-Controlled, and Cross-Over Study.

Di Pierro F, Sisti D, Rocchi M. Effects of Melissa officinalis Phytosome on Sleep Quality: Results of a Prospective, Double-Blind, Placebo-Controlled, and Cross-Over Study Nutrients, 2024. PMID 39683592

Result not recorded
Design
Prospective, double-blind, placebo-controlled crossover trial, 2 weeks per period
Sample
n = 30
Population
Adults aged 18-65 with fatigue on waking and unrefreshing sleep
Funding
No external funding stated; lead author is scientific director of Pharmextracta (product maker), two authors are Pharmextracta consultants

The effects of Melissa officinalis supplementation on depression, anxiety, stress, and sleep disorder in patients with chronic stable angina.

Haybar H, Javid AZ, Haghighizadeh MH. The effects of Melissa officinalis supplementation on depression, anxiety, stress, and sleep disorder in patients with chronic stable angina Clin Nutr ESPEN, 2018. PMID 29908682

Result not recorded
Design
Randomized, double-blind, placebo-controlled trial, 8 weeks
Sample
n = 80
Population
Patients with chronic stable angina (clinical population)
Funding
Ahvaz Jundishapur University of Medical Sciences; Nutrition and Metabolic Diseases Research Center; Student Research Committee (Crossref funders)

The effects of melissa officinalis on depression and anxiety in type 2 diabetes patients with depression: a randomized double-blinded placebo-controlled clinical trial.

Safari M, Asadi A, Aryaeian N. The effects of melissa officinalis on depression and anxiety in type 2 diabetes patients with depression: a randomized double-blinded placebo-controlled clinical trial BMC Complement Med Ther, 2023. PMID 37131158

Result not recorded
Design
Randomized, double-blind, placebo-controlled trial, 12 weeks
Sample
n = 60
Population
Adults with type 2 diabetes and depressive symptoms (clinical population)
Funding
not stated in the PubMed or Crossref record; full text not read (authors declared no conflict of interest)

The possible "calming effect" of subchronic supplementation of a standardised phospholipid carrier-based Melissa officinalis L. extract in healthy adults with emotional distress and poor sleep conditions: results from a prospective, randomised, double-blinded, placebo-controlled clinical trial.

Bano A, Hepsomali P, Rabbani F. The possible "calming effect" of subchronic supplementation of a standardised phospholipid carrier-based Melissa officinalis L. extract in healthy adults with emotional distress and poor sleep conditions: results from a prospective, randomised, double-blinded, placebo-controlled clinical trial Front Pharmacol, 2023. PMID 37927585

Result not recorded
Design
Randomized, double-blind, placebo-controlled, parallel-group trial, 3 weeks
Sample
n = 100
Population
Healthy adults with moderate depression, anxiety or stress scores or poor sleep
Funding
No funding statement; authors declare no commercial relationships; Indena S.p.A. provided the extract (Relissa) and placebo tablets

Search and history

Search (): (melissa[ti] OR "lemon balm"[ti]) AND (sleep[tiab] OR insomnia[tiab])

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