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Drugs and Health Products

Monograph: Valerian

This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLA) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient. It is a referenced document to be used as a labelling standard. Notes: (i) Text in parentheses is additional optional information which can be included on the PLA and product labels at the applicant's discretion. The solidus (/) indicates that the terms are synonyms or that the statements are synonymous. Either term or statement may be selected by the applicant. (ii) Claims for traditional use must include the term "Herbal Medicine".

Date: 2008-10-31

NHPID Name

Valeriana officinalis (USDA 2008)

Proper Name(s)

Valeriana officinalis L. (Valerianaceae) ( USDA 2008 )

Common Name(s)

Source Material


Route Of Administration

Oral

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:

Dose(s)

Adults:

Preparation: All Standardised Extracts

Dose(s):
0.3 - 12 Grams per day dried root or root and rhizome , not to exceed 3.6 Grams per single dose
 (EMEA 2006, Mills and Bone 2005, Ziegler et al. 2002, Blumenthal et al. 2000, Donath et al. 2000, Bradley 1992, Balderer and Borbély 1985, Leathwood and Chauffard 1985, BHP 1983, Leathwood et al. 1982)

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

Dose(s):

  • For sleep aid products, the following directions of use are optional: (i) Take a single dose 30 to 60 minutes before bedtime (Ziegler et al. 2002; Dominguez et al. 2000; Donath et al. 2000; Balderer and Borbély 1985; Leathwood and Chauffard 1985; Leathwood et al. 1982). (ii) Take an earlier dose during the evening if necessary (EMEA 2006).
  • 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.
  • Consumption with alcohol, other medications or natural health products with sedative properties is not recommended  (Brinker 2001, Gennaro 2000)
  • Sleep aid:
    Consult a health care practitioner if sleeplessness persists continuously for more than 3 weeks (chronic insomnia)  (EMEA 2006, Berardi et al. 2002, DiPiro et al. 2002)

Contraindication(s):
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 within 2 hours of consumption  (EMEA 2006, ESCOP 2003, Bradley 1992)

Non-medicinal ingredients

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

Specifications

  • 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 one of the following pharmacopoeial monographs: (i) 'Valerian' monograph in the British Pharmacopoeia, (ii) 'Valerian Dry Hydroalcoholic Extract', 'Valerian Root' or 'Valerian Tincture' from the European Pharmacopoeia, and (iii) 'Valerian', 'Powdered Valerian', 'Powdered Valerian Extract' or 'Valerian Tablets' from the US Pharmacopoeia.

References cited

  • Balderer G, Borbély AA. 1985. Effect of valerian on human sleep. Psychopharmacology 87(4):406-409.
  • 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.
  • BHP 1983: British Herbal Pharmacopoeia. Cowling (GB): British Herbal Medical Association; 1983.
  • BHP 1996: British Herbal Pharmacopoeia. Bournemouth (UK): British Herbal Medical Association; 1996.
  • Blumenthal M, Goldberg A, Brinckmann J, editors. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications; 2000.
  • Bradley PR, editor. 1992. British Herbal Compendium: A Handbook of Scientific Information on Widely Used Plant Drugs, Volume 1. Bournemouth (GB): British Herbal Medicine Association.
  • Brinker F. 2001. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications.
  • Brinker F. The Toxicity of Botanical Medicines. Sandy (OR): Eclectic Medical Publications; 2000.
  • 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.
  • Dominguez RA, Bravo-Valverde RL, Kaplowitz BR, Cott JM. 2000. Valerian as a hypnotic for Hispanic patients. Cultural Diversity and Ethnic Minority Psychology 6(1):84-92.
  • Donath F, Quispe S, Diefenbach K, Maurer A, Fietze I, Roots I. 2000. Critical evaluation of the effect of valerian extract on sleep structure and sleep quality. Pharmacopsychiatry 33(6):47-53.
  • Ellingwood F. 1983. American Materia Medica, Therapeutics and Pharmacognosy. Sandy (OR): Eclectic Medical Publications [Reprint of 1919 original].
  • EMEA 2006. European Medicines Agency. Community Monograph on Valeriana Officinalis L., Radix. London (UK): EMEA Committee on Herbal Medicinal Products (HMPC), 26 October 2006. Available from: http://www.emea.europa.eu/htms/human/hmpc/monograph/valerianae_radix.htm [Accessed 11 June 2008].
  • ESCOP 2003: ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2nd edition. Exeter (UK): European Scientific Cooperative on Phytotherapy and Thieme; 2003.
  • European Pharmacopoeia, 6th edition. Strasbourg (France): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM).; 2008
  • Felter HW, Lloyd JU. 1983. King's American Dispensatory, Volume 2, 18th edition. Sandy (OR): Eclectic Medical Publications [Reprint of 1898 original].
  • Felter HW. The Eclectic Materia Medica, Pharmacology and Therapeutics. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1922 original].
  • Gennaro AR, editor. Remington: The Science and Practice of Pharmacy, 20th edition. Washington (DC): Lippincott Williams and Wilkins; 2000
  • Gerhard U, Linnenbrink N, Georghiadou C, Hobi V. 1996. [Vigilance-decreasing effects of 2 plant-derived sedatives]. Vigilanzmindernde Effekte zweier pflanzlicher Schlafmittel. Schweiz Rundsch Med Prax 85(15): 473-481 (in German).
  • Hoffmann D. 2003. Medical Herbalism: The Science and Practice of Herbal Medicine. Rochester (VT): Healing Arts Press.
  • Leathwood PD, Chauffard F, Heck E, Munoz-Box R. 1982. Aqueous extract of valerian root (Valeriana officinalis L.) improves sleep quality in man. Pharmacology Biochemistry & Behavior 17(1):65-71.
  • Leathwood PD, Chauffard F. 1985. Aqueous extract of valerian reduces latency to fall asleep in man. Planta Medica 51(2):144-148.
  • McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. 2000. Herbs of Commerce, 2nd edition. Austin(TX): American Herbal Products Association.
  • Mills S, Bone K. 2005. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone.
  • The United States Pharmacopeia and the National Formulary (USP 31/NF 26). 2008. Rockville (MD): United States Pharmacopeial Convention, Inc.
  • USDA 2008: ARS, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2008-01-21]. Available at http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
  • Ziegler G, Ploch M, Miettinen-Baumann A, Collet W. 2002. Efficacy and tolerability of valerian extract LI 156 compared with oxazepam in the treatment of non-organic insomnia - a randomized, double-blind, comparative clinical study. European Journal of Medical Research 7(11):480-486.

References reviewed

  • Andreatini R, Sartori VA, Seabra MLV, Leite JR. 2002. Effect of valepotriates (valerian extract) in generalized anxiety disorder : a randomized placebo-controlled pilot study. Phytotherapy Research 16(7):650-654.
  • Barnes J, Anderson LA, Philipson JD. 2007. Herbal Medicines, 3rd edition. London (GB): Pharmaceutical Press.
  • Bent S, Padula A, Moore D, Patterson M, Mehling W. 2006. Valerian for sleep: a systematic review and meta-analysis. The American Journal of Medicine 119(12):1005-1012.
  • Bliwise DL, Ansari FP. 2007. Insomnia associated with valerian and melatonin usage in the 2002 National Health Interview survey. Sleep 30(7):881-884.
  • Blumenthal M, Busse W, Goldberg A, Gruenwald J, Hall T, Riggins C, Rister R, editors. The Complete German Commission E Monographs: Therapeutic Guide to Herbal Medicines. Austin (TX): American Botanical Council; 1998.
  • Blumenthal M, Hall T, Goldberg A, Kunz T, Kinda K, editors. 2003. The ABC Clinical Guide to Herbs. Austin (TX): American Botanical Council
  • Boon H, Smith MJ. 2004. The Complete Natural Medicine Guide to the 50 Most Common Medicinal Herbs, 2nd edition. Toronto (ON): Robert Rose Inc.
  • Bove M. 2001. An Encyclopedia of Natural Healing for Children and Infants, 2nd edition. Toronto (ON): McGraw-Hill.
  • BP 2008: British Pharmacopoeia, Volume 1. Londron (UK): British Pharmacopoeia Commission. The Stationary Office.
  • Brinker F. 2010. Online Updates and Additions to Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications. [Updated 2010 July 13; Accessed 2013 January 30]. Available from: http://www.eclecticherb.com/emp/updatesHCDI.html
  • Chandler F, editor. 2000. Herbs: Everyday Reference for Health Professionals. Ottawa (ON): Canadian Pharmacists Association and the Canadian Medical Association.
  • Cook, WH. The Physio-medical Dispensatory. Cincinnati (OH): WH Cook; 1869. [Accessed 2008-02-14]. Available from: http://medherb.com/cook/home.htm
  • Coxeter P, Schluter PJ, Eastwood HL, Nikles CJ, Glasziou PP. 2003. Valerian does not appear to reduce symptoms for patients with chronic insomnia in general practice using a series of randomized n-of-1 trials. Complementary Therapies in Medicine 11(4):215-222.
  • Diaper A, Hindmarch I. 2004. A double-blind, placebo-controlled investigation of the effects of two doses of a valerian preparation on the sleep, cognitive and psychomotor function of sleep-disturbed older adults. Phytotherapy Research 18(10):831-836.
  • Dorn M. 2000. [Efficacy and tolerability of Baldrian versus oxazepam in non-organic and non-psychiatric insomniacs: a randomized, double-blind, clinical, comparative study]. Wirksamkeit und Verträglichkeit von Baldrian versus Oxazepam bei nichtorganischen und nichtpsychiatrischen Insomnien: Eine randomisierte, doppelblinde, klinische Vergleichsstudie. Forsch Komplementarmed Klass Naturheilkd 7(2):79-84 (in German).
  • Geller SE, Studee L. 2007. Botanical and dietary supplements for mood and anxiety in menopausal women. The Journal of The North American Menopause Society 14(3):541-549.
  • Gooneratne NS. 2008. Complementary and alternative medicine for sleep disturbances in older adults. Clinics in Geriatric Medicine 24(1):121-138.
  • Holst L, Nordeng H, Haavik S. 2008. Use of herbal drugs during early pregnancy in relation to maternal characteristics and pregnancy outcome. Pharmacoepidemiology and Drug Safety 17(2):151-159.
  • JC 2008: Justice Canada. Food and Drug Regulations. (C.01.021). Ottawa (ON): Health Canada; 2008. [Accessed 2008-01-31] Available from: http://laws.justice.gc.ca/en/F-27/C.R.C.-c.870/text.html
  • Kohnen W, Oswald WD. 1988. The effects of valerian, propanolol, and their combination on activation, performance, and mood of healthy volunteers under social stress conditions. Pharmacopsychiatry 21(6):447-448.
  • Kuhlmann J, Berger W, Podzuweit H, Schmidt U. 1999. The influence of valerian treatment on "reaction time, alertness and concentration" in volunteers. Pharmacopsychiatry 32(6):235-241.
  • Leathwood PD, Chauffard F. 1982/83. Quantifying the effects of mild sedatives. Journal of Psychiatric Research 17(2):115-122.
  • Mayer B, Springer E. 1974. [Psychoexperimental studies on the effect of a valepotriate combination as well as the combined effects of valtatum and alcohol]. Psychoexperimentelle Untersuchungen zur Wirkung einer Valepotriatkombination sowie zur kombinierten Wirkung von Valtratum und Alkohol. Arzneimittelforschung 24(12):2066-2070 (in German).
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Appendix 1: Examples of appropriate dosage preparations, frequencies of use and directions for use

Dried root:

0.3-1 g, up to 3-4 times per day (EMEA 2006)

Dried root and rhizome:

  • 3-9 g, per day (Mills and Bone 2005)
  • 1-3 g, up to 3 times per day (Bradley 1992)

Infusion:

  • 1-3 g dried root, up to 3-4 times per day (EMEA 2006)
  • 3-9 g dried root and rhizome, per day (Mills and Bone 2005)
  • 2-3 g dried root, once to several times per day, not to exceed 12 g per day (Blumenthal et al. 2000)
  • 1-3 g dried root and rhizome, up to 3 times per day (Bradley 1992)

Decoction:

0.3-1 g dried root and rhizome, 3 times per day (BHP 1983)

Fluid extract:

0.3-1 g dried equivalent, 3 times per day (1:1, 60% alcohol, 0.3-1 ml) (BHP 1983)

Tincture:

  • 1-3 g dried equivalent, per day (1:2, 2-6 ml) (Mills and Bone 2005)
  • 1.8-3 g dried equivalent, per day (1:5, 9-15 ml) (Mills and Bone 2005)
  • 0.6-1 g dried equivalent, up to 3 times per day (1:5, 70% ethanol, 3-5 ml) (Bradley 1992)

Solid extract:

  • 1-3 g dried equivalent, up to 3-4 times per day (EMEA 2006)
  • 1.8-3.6 g dried equivalent, per day (3-6:1, 70% ethanol, 0.6 g) (Ziegler et al. 2002)
  • 1.4 g dried equivalent, per day (Dominguez et al. 2000)
  • 3 g dried equivalent, per day (5:1, 0.6 g) (Donath et al. 2000)
  • 1.3 g dried equivalent, per day (2.8:1, 0.45 g) (Balderer and Borbély 1985)
  • 2.5 g dried equivalent, per day (2.8:1, 0.9 g) (Balderer and Borbély 1985)
  • 1.4 g dried equivalent, per day (3.1:1, 0.45 g) (Leathwood and Chauffard 1985)
  • 2.8 g dried equivalent, per day (3.1:1, 0.9 g) (Leathwood and Chauffard 1985)
  • 1.1 g dried equivalent, per day (2.8:1, 0.4 g) (Leathwood et al. 1982)
  • Directions for use for sleep aid products: For best results, take a single dose of 1-3.6 g dried root or root and rhizome, 30 to 60 minutes before bedtime (Ziegler et al. 2002; Dominguez et al. 2000; Donath et al. 2000; Balderer and Borbély 1985; Leathwood and Chauffard 1985; Leathwood et al. 1982). Take an earlier dose during the evening if necessary (EMEA 2006).