Monograph: Valerian

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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: 2019-02-25

NHPID name

Valeriana officinalis ( Germplasm Resources Information Network Taxonomy )

Proper name(s)

Valeriana officinalis ( USDA 2008 )

Common name(s)

Source material

Route Of administration


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:




1 Day per day

Directions for use: Take a single dose 30 to 60 minutes before bedtime.


1 Day per day

Directions for use: Take an earlier dose during the evening if necessary.

Duration of use

No statement is required

Risk information

Statement(s) to the effect of:

Caution(s) and Warning(s): 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.  (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.


References cited

References reviewed

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:



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)


Solid extract: