Skullcap

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Note: The archived version of this monograph has been temporarily removed. For an electronic copy of this archived version, please contact the Natural Health Products Directorate (NHPD) at NHPD_DPSN@hc-sc.gc.ca.

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Date: January 18, 2008

Proper name(s): Scutellaria lateriflora L. (Lamiaceae) (USDA 2008)

Common name(s): Scullcap, skullcap (McGuffin et al. 2000)

Source material(s): Aerial parts (Barnes et al. 2007)

Route(s) of administration: Oral

Dosage form(s): Those suited to the allowable routes 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 to help relieve nervousness (calmative/sedative) (Bradley 2006; Boon and Smith 2004; Hoffmann 2003; Tilgner 1999; Williamson et al. 1988; Ellingwood 1983 [1919]; Felter and Lloyd 1983 [1898]).
• Traditionally used in Herbal Medicine as a sleep aid (in cases of restlessness or insomnia due to stress) (Bradley 2006; Tilgner 1999; Ellingwood 1983 [1919]; Felter and Lloyd 1983 [1898]).
• Traditionally used in Herbal Medicine to help relieve the pain associated with menstruation (antispasmodic) (Bradley 2006; Boon and Smith 2004; Mills and Bone 2000).

Dose(s): Preparations equivalent to 0.25-12 g dried aerial parts, per day (Bradley 2006; Mills and Bone 2005; Boon and Smith 2004; Williamson et al. 1988; BHP 1983).

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 required.

Risk information: Statement(s) to the effect of:

Caution(s) and warning(s):

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).

All products:

• Consult a health care practitioner if symptoms persist or worsen.
• Consumption with alcohol, other drugs and/or natural health products with sedative properties is not recommended (Brinker 2001; Gennaro 2000).

Contraindication(s): Do not use if you are pregnant or breastfeeding (Barnes et al. 2007; Boon and Smith 2004).

Known adverse reaction(s): Some people may experience drowsiness (Bradley 2006; Tilgner 1999; Williamson et al. 1988; Ellingwood 1983 [1919]; Felter and Lloyd 1983 [1898]). Exercise caution if operating heavy machinery, driving a motor vehicle or involved in activities requiring mental alertness

Non-medicinal ingredients: Must be chosen from the current NHPD List of Acceptable Non-medicinal Ingredients and must meet the limitations outlined in the list.

Specifications: Must comply with the minimum specifications outlined in the current NHPD Compendium of Monographs.

References cited:

Barnes J, Anderson LA, Philipson JD. Herbal Medicines, 3rd edition. London (UK): The Pharmaceutical Press; 2007.

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.

Boon H, Smith MJ. The Complete Natural Medicine Guide to the 50 Most Common Medicinal Herbs, 2nd edition. Toronto (ON): Robert Rose Inc; 2004.

BHP 1983: British Herbal Pharmacopoeia. Cowling (UK): British Herbal Medical Association; 1983.

Bradley PR, editor. British Herbal Compendium: A Handbook of Scientific Information on Widely Used Plant Drugs, Volume 2. Bournemouth (UK): British Herbal Medicine Association; 2006.

Brinker F. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications; 2001.

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.

Ellingwood F. American Materia Medica, Therapeutics and Pharmacognosy. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1919 original].

Felter HW, Lloyd JU. King's American Dispensatory, Volume 1, 18th edition. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1898 original].

Gennaro AR, editor. Remington: The Science and Practice of Pharmacy, 20th edition. Washington (DC): Lippincott Williams and Wilkins; 2000.

Hoffmann D. Medical Herbalism. Rochester (VT): Healing Arts Press; 2003.

McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. Herbs of Commerce, 2nd edition. Silver Spring (MD): American Herbal Products Association; 2000.

Mills S, Bone K. Principles and Practice of Phytotherapy. Toronto (ON): Churchill Livingstone; 2000.

Mills S, Bone K. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone; 2005.

Tilgner S. Herbal Medicine from the Heart of the Earth. Creswell (OR): Wise Acre Press; 1999.

Williamson EM, Evans FJ, Wren RC. Potter's New Cyclopaedia of Botanical Drugs and Preparations. Saffron Walden (UK): C.W. Daniel Company Limited; 1988.

USDA 2008: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). Scutellaria lateriflora L. National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2008-01-14]. Available from: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl

References reviewed:

McGuffin M, Hobbs C, Upton R, Goldberg A, editors. American Herbal Products Association's Botanical Safety Handbook. Boca Raton (FL): CRC Press; 1997.

Appendix 1: Examples of appropriate dosage preparations and frequencies of use

Dried aerial parts:

• 1-2 g, 3 times per day (Bradley 2006)
• 3-6 g, per day (Mills and Bone 2005)
• 0.5-2 g, 1-4 times per day (Boon and Smith 2004)
• 1-2 g, per day (Williamson et al. 1988)
• 1-2 g, 3 times per day (BHP 1983)

Infusion:

• 2 g dried aerial parts, 3 times per day (Bradley 2006)
• 3-6 g dried aerial parts, per day (Mills and Bone 2005)
• 1-2 g dried aerial parts, 3 times per day (BHP 1983)

Fluidextract:

• 2-4 g dried equivalent, 3 times per day
  (1:1, 25% ethanol, 2-4 ml) (Bradley 2006)
• 6-12 g dried equivalent, per day
  (1:1, 6-12 ml) (Mills and Bone 2005)
• 0.5-2 g dried equivalent, 1 to 4 times per day
  (1:1, 25 % alcohol, 0.5-2 ml) (Boon and Smith 2004)
• 2-4 g dried equivalent, 3 times per day
  (1:1, 25% alcohol, 2-4 ml) (BHP 1983)

Tincture:

• 0.4 g dried equivalent, 3 times per day
  (1:5, 45% ethanol, 2 ml) (Bradley 2006)
• 0.6-1.2 g dried equivalent, per day
  (1:5, 3-6 ml) (Mills and Bone 2005)
• 0.25-0.5 g dried equivalent, 1-4 times per day
  (1:8, 25% alcohol, 2-4 ml) (Boon and Smith 2004)
• 0.2-0.4 g dried equivalent, 3 times per day
  (1:5, 45% alcohol, 1-2 ml) (BHP 1983)