Safety Profile
Known Safety Concerns
- Sedative — caution with driving, alcohol, and CNS depressants (additive); thyroid hormone synthesis inhibition (caution in hypothyroidism); theoretical MAOI serotonin interaction
Contraindications
- Sedative — caution with driving, alcohol, and CNS depressants (additive); thyroid hormone synthesis inhibition (caution in hypothyroidism); theoretical MAOI serotonin interaction
Interactions
Information not yet available for this ingredient profile.
Evidence and Scientific Findings
Ingredient Overview
Lemon balm (Melissa officinalis, Lamiaceae) is a perennial herb used for anxiety, stress, insomnia, and cognitive support. Active constituents: rosmarinic acid (antioxidant, anti-inflammatory, antiviral), flavonoids (luteolin, apigenin), triterpenes (oleanolic acid, ursolic acid), and volatile oils (citral, citronellal, linalool). Mechanisms: GABA-transaminase inhibition (increases GABA → anxiolytic, sedative); cholinesterase inhibition (AChE and BuChE — cognitive effects); antioxidant. Clinical RCTs: modest anxiolytic effect (reduced self-reported stress), improved sleep quality, mild cognitive enhancement at 300–600 mg extract doses. Also used topically for HSV-1 cold sores (rosmarinic acid antiviral). Sedative effect — caution driving/machinery; additive sedation with benzodiazepines, alcohol, barbiturates, opioids, antihistamines, valerian. THYROID INTERACTION: Melissa extracts inhibit TSH binding and may suppress thyroid hormone synthesis — caution in hypothyroidism; monitor thyroid function with regular use. Possible serotonin interaction at high doses — theoretical caution with MAOIs. Generally safe short-term (4–8 weeks). Avoid pharmacological doses in pregnancy and nursing (insufficient safety data).
Biological and Chemical Classification
- Scientific Name
- Melissa officinalis
Mechanism of Action
Information not yet available for this ingredient profile.
Clinical Evidence of Effectiveness
Information not yet available for this ingredient profile.
Pharmacokinetics
Information not yet available for this ingredient profile.
Recommended Dosage
Information not yet available for this ingredient profile.
SETI — Scientific Evidence Transparency Index
Executive Summary — Ingredient Assessment
- 10 studies reviewed
- 0 high-quality studies (meta-analysis or RCT)
- Main clinical benefit observed: Botanical
- Evidence consistency: High consistency across studies (100%)
- Sedative — caution with driving, alcohol, and CNS depressants (additive); thyroid hormone synthesis inhibition (caution in hypothyroidism); theoretical MAOI serotonin interaction
The available scientific evidence for Lemon Balm indicates notable safety signals that warrant caution. Use should be considered carefully and monitored, particularly in sensitive populations or alongside other medications.
Total SETI Score
High risk| Evidence quality | 10/40 |
| Evidence consistency | 20/20 |
| Safety signals | 0/20 |
| Study recency | 9/10 |
| Evidence transparency | 9/10 |
Evidence Summary
- 10 studies reviewed
- 0 high-quality studies (meta-analysis or systematic review)
- 0 studies identified benefits or no safety concern (GREEN)
- 10 studies reported limited or advisory safety evidence (YELLOW)
Evidence Policy
Only peer-reviewed scientific literature indexed in PubMed or comparable databases is included in this evaluation. Commercial websites, blogs, and marketing materials are excluded. All references include direct traceable links to source documents.
Last updated: 06 აპრ 2026, 12:09
Evidence Distribution
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Observational / other LOW evidence YELLOWMycorrhizal colonization enhances the growth and physiological traits of Melissa officinalis under drought stress and Fusarium culmorum infection. ↗Saderi SZ et al.. Mycorrhizal colonization enhances the growth and physiological traits of Melissa officinalis under drought stress and Fusarium culmorum infection.. BMC Plant Biol. 2026. PMID:41864875.PMID 41864875 ↗Journal BMC Plant BiolYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41864875/
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Observational / other LOW evidence YELLOWPlasma and Brain Metabolomics Uncover Modulation of Bile Acid and Pentose Phosphate Pathways by Melissa officinalis in Obese Rat Model. ↗Aberkane FZ et al.. Plasma and Brain Metabolomics Uncover Modulation of Bile Acid and Pentose Phosphate Pathways by Melissa officinalis in Obese Rat Model.. Int J Mol Sci. 2026. PMID:41828608.PMID 41828608 ↗Journal Int J Mol SciYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41828608/
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Observational / other LOW evidence YELLOWThe acute effects of Zenserau2122 (Melissa officinalis L.) extract on mood and cognitive performance during cognitive overload: a randomised placebo-controlled, double-blind study… ↗Mathews I et al.. The acute effects of Zenserau2122 (Melissa officinalis L.) extract on mood and cognitive performance during cognitive overload: a randomised placebo-controlled, double-blind study in healthy young adults with moderate subjective stress.. Ther Adv Psychopharmacol. 2026. PMID:41782777.PMID 41782777 ↗Journal Ther Adv PsychopharmacolYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41782777/
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Observational / other LOW evidence YELLOWMelissa phospholipids improves sleep quality and mental well-being: concluding results from clinical study in adults with emotional distress. ↗Rondanelli M et al.. Melissa phospholipids improves sleep quality and mental well-being: concluding results from clinical study in adults with emotional distress.. Food Nutr Res. 2026. PMID:41777239.PMID 41777239 ↗Journal Food Nutr ResYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41777239/
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Observational / other LOW evidence YELLOWMelissa officinalis L. protects against reflux esophagitis by attenuating NF-u03baB- and MAPK-mediated inflammation in rats. ↗Kim HR et al.. Melissa officinalis L. protects against reflux esophagitis by attenuating NF-u03baB- and MAPK-mediated inflammation in rats.. J Ethnopharmacol. 2026. PMID:41775309.PMID 41775309 ↗Journal J EthnopharmacolYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41775309/
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Observational / other LOW evidence YELLOWMelissa officinalis L. (Lemon Balm): An Integrative Review of Phytochemistry and Evidence from Preclinical Research to Clinical Studies. ↗Cu00eempeanu IA et al.. Melissa officinalis L. (Lemon Balm): An Integrative Review of Phytochemistry and Evidence from Preclinical Research to Clinical Studies.. Plants (Basel). 2026. PMID:41754356.PMID 41754356 ↗Journal Plants (Basel)Year 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41754356/
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Observational / other LOW evidence YELLOWMedicinal Plants for Major Depressive Disorder. ↗Bertollo AG et al.. Medicinal Plants for Major Depressive Disorder.. Brain Sci. 2026. PMID:41750223.PMID 41750223 ↗Journal Brain SciYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41750223/
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Observational / other LOW evidence YELLOWLemon balm-derived nanovesicles restore mitochondrial function and reduce cytokine production in skin fibroblasts under pro-inflammatory conditions. ↗Kulkovienu0117 G et al.. Lemon balm-derived nanovesicles restore mitochondrial function and reduce cytokine production in skin fibroblasts under pro-inflammatory conditions.. Eur J Pharm Sci. 2026. PMID:41734866.PMID 41734866 ↗Journal Eur J Pharm SciYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41734866/
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Observational / other LOW evidence YELLOWEnhancing rosmarinic acid accumulation and drought tolerance in Melissa officinalis through arbuscular mycorrhizal fungi and plant growth-promoting rhizobacteria inoculation. ↗Muhealddin BS. Enhancing rosmarinic acid accumulation and drought tolerance in Melissa officinalis through arbuscular mycorrhizal fungi and plant growth-promoting rhizobacteria inoculation.. 3 Biotech. 2026. PMID:41710477.PMID 41710477 ↗Journal 3 BiotechYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41710477/
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Observational / other LOW evidence YELLOWLemon Balm. ↗Lemon Balm.. 2006. PMID:30000901.PMID 30000901 ↗Year 2006Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/30000901/
Score Transparency
0 of 10 approved references (score saturates at 10). More peer-reviewed studies = stronger evidence base.
Method: Q = number of approved references ÷ 10 (capped at 1.0)
Limited — mostly case reports or animal studies
Method: L = mean study-level weight across approved references. Level 1 (meta-analysis / systematic review) = 1.0; Level 2 (RCT) = 0.8; Level 3 (cohort/case-control) = 0.6; Level 4 (case report) = 0.4; Level 5 (animal / in-vitro) = 0.2.
Mixed or neutral — roughly equal benefit and risk signals
Method: D = (sum of risk-scored references − sum of benefit-scored references) ÷ total evidence score, then scaled from [−1, 1] to [0, 1]. 0.0 = pure benefit; 0.5 = neutral; 1.0 = pure risk.
One or more monitoring-level safety signals active
Method: S = 0.5 (neutral baseline) + sum of active signal severity deltas ÷ 10. Severity deltas: Critical = +2.0, High = +1.5, Moderate = +1.0, Low = +0.5. Capped at 1.0.
Final GIRI Score for Lemon Balm. Risk level thresholds: Low 0–3.0 · Moderate 3.0–5.5 · High 5.5–7.5 · Critical 7.5–10.
Full methodology & data sources
The GIRI Score is computed entirely from structured data — no editorial scoring or subjective weighting is applied at any step.
- References: Only approved references are counted. Each reference is assigned an evidence level (L1–L5) and a direction (risk / neutral / benefit) by the reference manager or AI classifier.
- Safety Signals: Sourced from regulatory agencies (FDA, EMA, Health Canada, TGA, and others) and pharmacovigilance databases. Only active signals count toward the score.
- Formula version: GIRI Score v3.7.0 — Q × L × D × S × 10.
- Limitations: The score reflects published evidence and recorded signals as of the last update date. It is not a clinical risk assessment and should not replace advice from a qualified healthcare professional.
Risk Level Classification
Based on available regulatory signals and scientific evidence, this ingredient presents a low safety concern under normal conditions of use.
0–3.0
3.0–5.5
5.5–7.5
7.5–10
The score pin shows exactly where this ingredient falls on the fixed risk scale.
What drove the Low classification for Lemon Balm
A score of 2.0 places this ingredient in the Low band. Thresholds: Low 0–3.0 · Moderate 3.0–5.5 · High 5.5–7.5 · Critical 7.5–10.
0 approved references.
Limited — mostly case reports or animal studies (Level 4–5).
Neutral or mixed — benefit and risk signals roughly balanced.
No active signals — S component is at neutral baseline (0.5), contributing no extra risk weight.
No major regulatory restrictions or advisories recorded across monitored jurisdictions (FDA, EMA, Health Canada, TGA, and others).
How are the Low / Moderate / High / Critical thresholds defined?
The four risk levels are fixed score bands. A score is assigned to exactly one level based on where it falls:
| Level | Score | Meaning |
|---|---|---|
| LOW | 0.0 – 2.9 | Sparse or predominantly beneficial evidence. No active safety alerts. |
| MODERATE | 3.0 – 5.4 | Mixed signals — some risk alongside benefit. Caution at high doses or in sensitive groups. |
| HIGH | 5.5 – 7.4 | Multiple studies or regulatory alerts documenting adverse effects. Professional oversight recommended. |
| CRITICAL | 7.5 – 10 | Regulatory restrictions in one or more major jurisdictions. Serious documented harm. Avoid without specialist supervision. |
Thresholds are fixed constants (GIRI_Score_Utils::LEVEL_THRESHOLDS). They do not change per ingredient and are never subject to editorial adjustment.