02 February 2016

EMA/HMPC/150848/2015,

Corr.

1

Committee on Herbal Medicinal Products (HMPC)

European Union herbal monograph on

Valeriana officinalis

L., radix

Final

Initial assessment

Discussion in Working Party on European Union monographs and list

(MLWP)

Adoption by Committee on Herbal Medicinal Products (HMPC) for

release for consultation

End of consultation (deadline for comments)

Re-discussion in MLWP

Adoption by HMPC

Monograph (EMEA/HMPC/340719/2005)

AR (EMEA/HMPC/167391/2006)

List of references (EMEA/HMPC/167392/2006)

Overview of comments received during the public consultation

(EMEA/HMPC/50774/2006)

HMPC Opinion (EMEA/HMPC/313368/2006)

First systematic review

Discussion in MLWP

January 2015

March 2015

May 2015

Adopted by HMPC for release for consultation

Start of public consultation

End of consultation (deadline for comments)

Re-discussion in MLWP

Adoption by HMPC

7 July 2015

22 July 2015

31 October 2015

November 2015

2 February 2016

31 January 2006

May 2006

July 2006

13 July 2006

May 2005

June 2005

September 2005

20 September 2005

1

Correction under ii) Herbal preparations, point h

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Keywords

Herbal medicinal products; HMPC; European Union herbal monographs; well-

established medicinal use; traditional use;

Valeriana officinalis

L., radix;

Valerianae radix; Valerian root

BG (bulgarski): Валериана, корен

CS (čeština): kozlíkový kořen

DA (dansk): Baldrianrod

DE (Deutsch): Baldrianwurzel

EL (elliniká): Ρίζα βαλεριανής

EN (English): Valerian root

ES (español): Valeriana, raíz de

ET (eesti keel): palderjanijuur

FI (suomi): rohtovirmajuuri, juuri

FR (français): Valériane (racine de)

HR (hrvatski): odoljenov korijen

HU (magyar): Macskagyökér

IT (italiano): Valeriana radice

LT (lietuvių kalba): Valerijonų šaknys

LV (latviešu valoda): Baldriāna saknes

MT (Malti): Għerq tal-Valerjana

NL (Nederlands): Valeriaanwortel

PL (polski): Korzeń kozłka

PT (português): Valeriana, raiz

RO (română): rădăcină de valeriană

SK (slovenčina): Koreň valeriány

SL (slovenščina): korenina zdravilne špajke

SV (svenska): Vänderot, rot

IS (íslenska):

NO (norsk): Valerianarot

European Union herbal monograph on

Valeriana officinalis

L., radix

EMA/HMPC/150848/2015

Page 2/9



European Union herbal monograph on

Valeriana officinalis

L.,

radix

1. Name of the medicinal product

To be specified for the individual finished product.

2. Qualitative and quantitative composition

2, 3

Well-established use

With regard to the marketing authorisation

application of Article 10(a) of Directive

2001/83/EC as amended

Valeriana officinalis

L., radix (Valerian root)

i) Herbal substance

Not applicable

ii) Herbal preparations

Dry extract (DER 3-7.4:1), extraction solvent:

ethanol 40-70% (V/V)

Traditional use

With regard to the registration application of

Article 16d(1) of Directive 2001/83/EC as

amended

Valeriana officinalis

L., radix (Valerian root)

i) Herbal substance

Not applicable

ii) Herbal preparations

a)

b)

c)

d)

e)

f)

g)

h)

i)

j)

Comminuted herbal substance

Powdered herbal substance

Expressed juice from fresh root (1:0.60-

0.85)

Dry extract (DER 4-6:1), extraction solvent:

water

Liquid extract (DER 1:4-6), extraction

solvent: water

Dry extract (DER 4-7:1), extraction solvent:

methanol 45% (V/V)

Dry extract (DER 5.3-6.6:1), extraction

solvent: methanol 45% (m/m)

Liquid extract (DER 1:7-9), extraction

solvent: sweet wine

Liquid extract (DER 1:1), extraction solvent:

ethanol 60% (V/V)

Tincture (ratio of herbal substance to

extraction solvent 1:8), extraction solvent:

ethanol 60% (V/V)

k)

Tincture (ratio of herbal substance to

extraction solvent 1:10), extraction solvent:

ethanol 56%

l)

Tincture (ratio of herbal substance to

extraction solvent 1:5), extraction solvent:

ethanol 70% (V/V)

The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal

quality guidance

.

3

2

The material complies with the Ph. Eur. monograph (ref.: 0453).

European Union herbal monograph on

Valeriana officinalis

L., radix

EMA/HMPC/150848/2015

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Well-established use

Traditional use

m) Tincture (ratio of herbal substance to

extraction solvent 1:5), extraction solvent:

ethanol 60-80% (V/V)

n)

Dry extract (DER 5.5-7.4:1), extraction

solvent: ethanol 85% (m/m)

3. Pharmaceutical form

Well-established use

Herbal preparations in solid dosage forms for

oral use.

The pharmaceutical form should be described by

the European Pharmacopoeia full standard term.

Traditional use

Comminuted herbal substance as herbal tea for

oral use.

Herbal preparation in liquid or solid dosage forms

for oral use.

Comminuted herbal substance for use as bath

additive.

The pharmaceutical form should be described by

the European Pharmacopoeia full standard term.

4. Clinical particulars

4.1. Therapeutic indications

Well-established use

Herbal medicinal product for the relief of mild

nervous tension and sleep disorders.

Traditional use

Traditional herbal medicinal product for relief of

mild symptoms of mental stress and to aid sleep.

The product is a traditional herbal medicinal

product for use in the specified indication

exclusively based upon long-standing use.

4.2. Posology and method of administration

4

Well-established use

Posology

Adolescents, adults and elderly

Oral use

Single dose: 400-600 mg dry extract;

For relief of mild nervous tension up to 3 times

daily.

Traditional use

Posology

Adolescents, adults and elderly

Oral use

a)

single dose: 0.3-3 g

For relief of mild symptoms of mental stress

up to 3 times daily.

To aid sleep, a single dose half to one hour

For guidance on herbal substance/herbal preparation administered as herbal tea or as infusion/decoction/macerate

preparation, please refer to the HMPC ‘Glossary on herbal teas’ (EMA/HMPC/5829/2010 Rev.1).

European Union herbal monograph on

Valeriana officinalis

L., radix

EMA/HMPC/150848/2015

4

Page 4/9



Well-established use

For relief of sleep disorders, a single dose half to

one hour before bedtime with an earlier dose

during the evening if necessary.

Maximum daily dose: 4 single doses

The use in children under 12 years of age is not

recommended (see section 4.4 ‘Special warnings

and precautions for use’).

Duration of use

Because of its gradual onset of efficacy valerian

root is not suitable for acute interventional

treatment of mild nervous tension or sleep

disorders. To achieve an optimal treatment

effect, continued use over 2-4 weeks is

recommended.

If the symptoms persist or worsen after 2 weeks

of continued use, a doctor or a pharmacist

should be consulted.

Method of administration

Oral use

Traditional use

before bedtime with an earlier dose during

the evening if necessary.

Herbal tea: 0.3-3 g of the comminuted

herbal substance in 150 ml of boiling water

as a herbal infusion

b)

single dose: 0.3-2.0 g

For relief of mild symptoms of mental stress

up to 3 times daily.

To aid sleep, a single dose half to one hour

before bedtime with an earlier dose during

the evening if necessary.

c)

single dose: 10 ml

For relief of mild symptoms of mental stress

up to 3 times daily.

To aid sleep, a single dose half to one hour

before bedtime with an earlier dose during

the evening if necessary.

d)

single dose: 420 mg

For relief of mild symptoms of mental stress

up to 3 times daily.

To aid sleep, a single dose half to one hour

before bedtime with an earlier dose during

the evening if necessary.

e)

single dose: 20 ml

For relief of mild symptoms of mental stress

up to 3 times daily.

To aid sleep, a single dose half to one hour

before bedtime.

f)

single dose: 144-288 mg

For relief of mild symptoms of mental stress

up to 4 times daily.

To aid sleep, a single dose half to one hour

before bedtime with an earlier dose during

the evening if necessary.

g)

single dose: 450 mg

For relief of mild symptoms of mental stress

up to 3 times daily.

To aid sleep, a single dose half to one hour

before bedtime with an earlier dose during

the evening if necessary.

h)

i)

j)

single dose: 10 ml, up to 3 times daily

single dose: 0.3-1.0 ml, up to 3 times daily

single dose: 4-8 ml, up to 3 times daily

European Union herbal monograph on

Valeriana officinalis

L., radix

EMA/HMPC/150848/2015

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Well-established use

Traditional use

k)

single dose: 0.84 ml

For relief of mild symptoms of mental stress

3-5 times daily.

To aid sleep, a single dose half an hour

before bedtime.

l)

single dose: 1.5 ml (mental stress), 3 ml (to

aid sleep)

For relief of mild symptoms of mental stress

up to 3 times daily.

To aid sleep, a single dose half an hour

before bedtime.

m) single dose: 10 ml, up to 3 times daily

n)

single dose: 322 mg, up to 3 times daily

The use in children under 12 years of age is not

recommended (see section 4.4 ‘Special warnings

and precautions for use’).

Use as bath additive

a)

single dose: 100 g for a full bath; up to 1

bath daily

The use in children under 12 years of age is not

recommended (see section 4.4 ‘Special warnings

and precautions for use’).

Duration of use

If symptoms persist during the use of the

medicinal product, a doctor or a qualified health

care practitioner should be consulted.

Method of administration

Oral use

Use as bath additive. Temperature: 34-37°C,

duration of bath 10-20 minutes.

4.3. Contraindications

Well-established use

Hypersensitivity to the active substance.

Traditional use

Hypersensitivity to the active substance.

Use as bath additive

Full baths are contraindicated in cases of open

wounds, large skin injuries, acute skin diseases,

European Union herbal monograph on

Valeriana officinalis

L., radix

EMA/HMPC/150848/2015

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Well-established use

Traditional use

high fever, severe infections, severe circulatory

disturbances and cardiac insufficiency.

4.4. Special warnings and precautions for use

Well-established use

The use is not recommended in children below

12 years of age due to a lack of data on safety

and efficacy.

If the symptoms worsen during the use of the

medicinal product, a doctor or a pharmacist

should be consulted.

Traditional use

The use in children under 12 years of age has not

been established due to lack of adequate data.

If the symptoms worsen during the use of the

medicinal product, a doctor or a qualified health

care practitioner should be consulted.

For tinctures and extracts containing ethanol, the

appropriate labelling for ethanol, taken from the

‘Guideline on excipients in the label and package

leaflet of medicinal products for human use’,

must be included.

4.5. Interactions with other medicinal products and other forms of

interaction

Well-established use

None reported

Traditional use

None reported

4.6. Fertility, pregnancy and lactation

Well-established use

Safety during pregnancy and lactation has not

been established. In the absence of sufficient

data, the use during pregnancy and lactation is

not recommended.

No fertility data available.

Traditional use

Safety during pregnancy and lactation has not

been established. In the absence of sufficient

data, use during pregnancy and lactation is not

recommended.

No fertility data available.

4.7. Effects on ability to drive and use machines

Well-established use

May impair ability to drive and use machines.

Affected patients should not drive or operate

machinery.

Traditional use

May impair ability to drive and use machines.

Affected patients should not drive or operate

machinery.

European Union herbal monograph on

Valeriana officinalis

L., radix

EMA/HMPC/150848/2015

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4.8. Undesirable effects

Well-established use

Gastrointestinal symptoms (e.g. nausea,

abdominal cramps) may occur after ingestion of

valerian root preparations. The frequency is not

known.

If other adverse reactions not mentioned above

occur, a doctor or a pharmacist should be

consulted.

Traditional use

Oral use

Gastrointestinal symptoms (e.g. nausea,

abdominal cramps) may occur after ingestion of

valerian root preparations. The frequency is not

known.

If other adverse reactions not mentioned above

occur, a doctor or a qualified health care

practitioner should be consulted.

Use as bath additive

None known

If adverse reactions occur, a doctor or a qualified

health care practitioner should be consulted.

4.9. Overdose

Well-established use

Valerian root at a dose of approximately 20 g

caused symptoms such as fatigue, abdominal

cramp, chest tightness, light-headedness, hand

tremor and mydriasis, which disappeared within

24 hours. If symptoms arise, treatment should

be supportive.

Traditional use

Oral use

Valerian root at a dose of approximately 20 g

caused symptoms, such as fatigue, abdominal

cramp, chest tightness, light-headedness, hand

tremor and mydriasis, which disappeared within

24 hours. If symptoms arise, treatment should

be supportive.

Use as bath additive

No case of overdose has been reported.

5. Pharmacological properties

5.1. Pharmacodynamic properties

Well-established use

Pharmacotherapeutic group: Hypnotics and

sedatives

Proposed ATC code: N05C M09

The sedative effects of preparations of valerian

root, which have long been recognised

empirically, have been confirmed in controlled

clinical studies. Orally administered dry extracts

of valerian root prepared with ethanol/water

European Union herbal monograph on

Valeriana officinalis

L., radix

EMA/HMPC/150848/2015

Traditional use

Not required as per Article 16c(1)(a)(iii) of

Directive 2001/83/EC as amended.

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Well-established use

(ethanol maximum 70% (V/V)) in the

recommended dosage have been shown to

improve sleep latency and sleep quality. These

effects cannot be attributed with certainty to any

known constituents.

Traditional use

5.2. Pharmacokinetic properties

Well-established use

No data available.

Traditional use

Not required as per Article 16c(1)(a)(iii) of

Directive 2001/83/EC as amended.

5.3. Preclinical safety data

Well-established use

Ethanol extracts of valerian root have shown low

toxicity in rodents during acute tests and from

repeated dose toxicity over periods of 4-8 weeks.

AMES-tests on mutagenicity for the dry extract

(4-7:1); extraction solvent ethanol 40% (V/V)

and the dry extract (DER 3-6:1), extraction

solvent ethanol 70% (V/V) did not give any

reason for concern.

Tests on reproductive toxicity and carcinogenicity

have not been performed.

Traditional use

AMES-tests on mutagenicity with extracts,

representing the two extremes of the polarity

range did not give any reason for concern.

Tests on reproductive toxicity and carcinogenicity

have not been performed.

6. Pharmaceutical particulars

Well-established use

Not applicable

Traditional use

Not applicable

7. Date of compilation/last revision

02 February 2016

European Union herbal monograph on

Valeriana officinalis

L., radix

EMA/HMPC/150848/2015

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