Valeriana officinalis (root extract)

Herbal sedative, EMA HMPC traditional herbal medicinal product

ATC code: N05CM09 (Valeriana (Valeriana officinalis))

Brand names

Nature's Way Valerian Root, NOW Valerian Root, Solgar Valerian Root Extract, Sedonium

Mechanism of action

Valerian root contains valerenic acid, valepotriates, essential oils and sesquiterpenes. Valerenic acid binds GABA-A receptors at the β3 subunit, potentiates GABA inhibitory signalling and inhibits GABA reuptake at the synaptic cleft. The effect is tens of times weaker than benzodiazepines and builds up over 2–4 weeks of regular use, not after a single dose. HMPC in 2016 classified valerian root extract as a traditional herbal medicinal product based on 30 years of European use, without large RCT confirmation. Valerenic acid bioavailability is low, and plasma concentrations vary 5–10-fold between extract manufacturers.

Indications

Insomnia and sleep disorders

Adjunct

Valerian is used for mild sleep disturbance and nervous tension. HMPC in 2016 confirmed traditional-use status for this indication – the decision rests on 30 years of European practice, not on large RCTs. The Taibi systematic review (Sleep Med Rev 2007) pooled 18 placebo-controlled studies and concluded that valerian is safe but shows no clinically meaningful effect on sleep latency, total sleep time or sleep quality. Individual RCTs give a weak positive signal, others give none. The 2021 insomnia guideline does not list valerian as a proven option. First-line treatment for chronic insomnia is cognitive-behavioural therapy for insomnia (CBT-I), not herbal products. If valerian was offered as a replacement for prescription hypnotics or a long-term course for severe insomnia, consider seeking a second opinion. For episodic nervous tension a single dose of 400–600 mg of extract taken 30–60 minutes before bed is reasonable.

Sources

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

Stress and anxiety

Not recommended

Valerian is often sold as a «natural alternative to benzodiazepines» for anxiety and stress. HMPC explicitly limits this position to mild nervous tension, not anxiety disorders. No positive RCTs exist in generalized anxiety disorder, panic disorder or social phobia. CG113 (2019) on anxiety disorders does not include valerian in the management algorithm. The standard remains CBT and SSRIs/SNRIs when needed. Valerian's effect on anxiety symptoms matches placebo in most comparisons. If valerian was offered as a replacement for a prescribed benzodiazepine or antidepressant in a diagnosed anxiety disorder, consider seeking a second opinion. For ordinary episodic nervousness before a public talk or a difficult conversation a short course is acceptable, but it is a symptomatic measure.

Sources

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Safety

Contraindications

Hypersensitivity to valerian
Age under 12 (EMA HMPC – no data)
Pregnancy and lactation
Severe hepatic impairment

Serious adverse effects

Rare hepatotoxicity reports with long-term use of combined herbal products containing valerian
Paradoxical insomnia and agitation
Potentiation of alcohol, benzodiazepines and opioids

Common adverse effects

Morning drowsiness after intake
Headache
Gastrointestinal discomfort
Dry mouth

PregnancyFDA N

Safety data in pregnancy are insufficient. EMA HMPC does not recommend use in pregnancy due to lack of adequate studies. Valepotriates show cytotoxicity in vitro at high concentrations. AEMPS classifies the product as a traditional herbal medicinal product without a pregnancy indication. Valerian is not prescribed in pregnancy.

Breastfeeding

Data on transfer of valerenic acid into human milk are lacking. EMA HMPC does not recommend use during lactation.

Calculate RID

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Frequently asked

What is Valeriana officinalis (root extract) used for?

Valeriana officinalis (root extract) is evaluated for the following indications with varying evidence strength: Insomnia and sleep disorders (evidence tier C), Stress and anxiety (evidence tier D). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Valeriana officinalis (root extract)?

Common side effects of Valeriana officinalis (root extract) (≥ 1 in 100): Morning drowsiness after intake, Headache, Gastrointestinal discomfort, Dry mouth. See the Safety section for uncommon and serious reactions.

Is Valeriana officinalis (root extract) safe during pregnancy?

FDA category N. Safety data in pregnancy are insufficient. EMA HMPC does not recommend use in pregnancy due to lack of adequate studies. Valepotriates show cytotoxicity in vitro at high concentrations. AEMPS classifies the product as a traditional herbal medicinal product without a pregnancy indication. Valerian is not prescribed in pregnancy.

Is Valeriana officinalis (root extract) compatible with breastfeeding?

Data on transfer of valerenic acid into human milk are lacking. EMA HMPC does not recommend use during lactation.

Who should not take Valeriana officinalis (root extract)?

Valeriana officinalis (root extract) is contraindicated in: Hypersensitivity to valerian; Age under 12 (EMA HMPC – no data); Pregnancy and lactation; Severe hepatic impairment. Full list in the Safety section.

Mechanism of action

Indications

Insomnia and sleep disorders

Adjunct

Sources

Safety

Contraindications

Hypersensitivity to valerian
Age under 12 (EMA HMPC – no data)
Pregnancy and lactation
Severe hepatic impairment

Serious adverse effects

Rare hepatotoxicity reports with long-term use of combined herbal products containing valerian
Paradoxical insomnia and agitation
Potentiation of alcohol, benzodiazepines and opioids

Common adverse effects

Morning drowsiness after intake
Headache
Gastrointestinal discomfort
Dry mouth

PregnancyFDA N

Breastfeeding

Data on transfer of valerenic acid into human milk are lacking. EMA HMPC does not recommend use during lactation.

Calculate RID

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Frequently asked

What is Valeriana officinalis (root extract) used for?

What are the side effects of Valeriana officinalis (root extract)?

Is Valeriana officinalis (root extract) safe during pregnancy?

Is Valeriana officinalis (root extract) compatible with breastfeeding?

Data on transfer of valerenic acid into human milk are lacking. EMA HMPC does not recommend use during lactation.

Who should not take Valeriana officinalis (root extract)?