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Drugs and Health Products

Monograph: Lemon Balm

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Date: 2008-03-17


Melissa officinalis (USDA 2008)

Proper Name(s)

Melissa officinalis L. (Lamiaceae) ( USDA 2008 )

Common Name(s)

Source Material

Herb top ( EMEA 2007 )

Route Of Administration

Oral ( EMEA 2007 )

Dosage Form(s)

Those suited to the allowable route(s) of administration. This monograph is not intended to include food-like dosage forms such as bars, chewing gums or beverages.

Use(s) or Purpose(s)

Statement(s) to the effect of:

  • Traditionally used in Herbal Medicine as a sleep aid (in cases of restlessness or insomnia due to mental stress)  (EMEA 2007)
  • Traditionally used in Herbal Medicine to help relieve digestive disturbances, such as dyspepsia  (EMEA 2007)


Adults and adolescents 13 and over:

Preparation: Dry, Powder, Decoction & Infusion + All Non-Standardised Extracts

Dose(s): 0.4 - 13.5 Grams per day, dried herb tops

See Appendix 1 for examples of appropriate dosage preparations and frequencies of use, according to cited references. The purpose of Appendix 1 is to provide guidance to industry.

Duration of use

No statement is required

Risk Information

Statement(s) to the effect of:

Caution(s) and Warning(s):
  • Consult a health care practitioner if symptoms persist.
  • Consult a health care practitioner if symptoms worsen.
  • Consult a health care practitioner prior to use if you are pregnant or breastfeeding  (EMEA 2007)
  • Consumption with alcohol, other medications or health products with sedative properties is not recommended  (EMEA 2007)
  • Sleep aid:
    Consult a health care practitioner if sleeplessness persists continuously for more than 3 weeks (chronic insomnia)  (Berardi et al. 2002, DiPiro et al. 2002)

No statement is required

Known Adverse Reaction(s):
Some people may experience drowsiness. Exercise caution if operating heavy machinery, driving a motor vehicle or involved in activities requiring mental alertness  (EMEA 2007)

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database and must meet the limitations outlined in the database.


  • The finished product specifications must be established in accordance with the requirements described in the NHPD Quality of Natural Health Products Guide.
  • The medicinal ingredient must comply with the requirements outlined in the Natural Health Products Ingredient Database (NHPID).
  • The medicinal ingredient may comply with the specifications outlined in the Lemon Balm Monograph published in the British Pharmacopoeia or the Melissa Leaf Monograph published in the European Pharmacopoeia.

References cited

  • Berardi RR, DeSimone EM, Newton GD, Oszko MA, Popovich NG, Rollins CJ, Shimp LA, Tietze KJ, editors. Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care, 13th edition. Washington (DC): American Pharmaceutical Association; 2002.
  • Dipiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey LM. Pharmacotherapy: a pathophysiologic approach, 5th edition. New York (NY): The McGraw-Hill Companies, Inc.; 2002.
  • EMEA 2007. European Medicines Agency. Community Monograph on . London (UK): EMEA Committee on Herbal Medicinal Products (HMPC), 31 October 2007. [Accessed 2008-03-17]. Available at:
  • USDA 2008: ARS, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2008-01-21]. Available at

Appendix 1 Examples of appropriate dosage preparations, frequencies of use and directions for use (EMEA 2007)

Dried aerial parts:

1.5-4.5 g, 1-3 times per day

Infusion: 1.5-4.5 g dried aerial parts, 1-3 times per day

Directions for use:

Pour 150 ml of boiling water over dried aerial parts and infuse for 5-15 minutes.


2-4 g dried equivalent, 1-3 times per day
(1:1, 45% ethanol, 2-4 ml)


0.4-1.2 g dried equivalent, 1-3 times per day
(1:5, 45% ethanol, 2-6 ml)