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Valerian and sleep: efficacy, use and risks of extracts

Valerian and sleep: efficacy, use and risks of extracts

Dry extract, tincture, or valerian tea: what the EMA recognizes, why a felt improvement doesn't prove a treatment for insomnia, and the risks to know.

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AT A GLANCE

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Dry extract, tincture, or valerian tea: what the EMA recognizes, why a felt improvement doesn't prove a treatment for insomnia, and the risks to know.

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Valerian (Valeriana officinalis) is used for its root, as a tea, a tincture, or a dry extract. These forms aren't equivalent: the European Medicines Agency (EMA) doesn't grant them the same status, and studies don't cover the same products. This article focuses on extracts, on what trials actually measure, and on the risks associated with their use.

01

Extract, tincture, or tea: two different statuses

The European monograph, revised in 2016, distinguishes two levels:

  • Well-established use: certain dry ethanolic root extracts, for relieving mild nervous tension and sleep disorders. This status requires at least 10 years of use in the European Union and published clinical studies.
  • Traditional use: other preparations, including root tea, for relieving mild symptoms of mental stress and helping with sleep. This status rests on at least 30 years of use, including 15 in the European Union, without sufficient trials.

Many "sleep" products combine valerian with hops, passionflower, or lemon balm. Their profile isn't that of a valerian extract studied alone.

02

What the studies actually measure

A systematic review published in 2000, covering nine randomized placebo-controlled trials, already judged the evidence inconclusive: small samples, varied extracts and doses, uneven methodological quality.

A 2024 general review, which analyzed eight systematic reviews, reaches the same conclusion. Valerian seems to improve sleep quality as participants perceive it, but this effect hasn't been confirmed by quantitative or objective measurements. The authors conclude that valerian has no empirical support for treating insomnia, while noting a good safety profile.

The NCCIH (the US National Institutes of Health) also describes the results as inconsistent. The American Academy of Sleep Medicine advises against valerian for treating chronic insomnia in adults.

03

Anxiety: don't extrapolate

A 2006 Cochrane review found only one trial, covering 36 people with generalized anxiety. No clear difference from placebo appeared, and the authors judged the data insufficient to draw conclusions about efficacy or safety.

A feeling of relaxation, traditional use for mild stress, and treatment of a diagnosed anxiety disorder are three distinct things. An anxiety disorder should not be managed through self-medication.

04

Drowsiness, driving, alcohol, and sedatives

According to the NCCIH, valerian appears safe for most adults at 300 to 600 mg per day for up to 6 weeks; its longer-term safety is unknown. Reported adverse effects include headaches, digestive disorders, a foggy feeling, excitability, vivid dreams, and malaise.

After prolonged use, abrupt discontinuation can cause withdrawal symptoms: anxiety, irritability, heart disturbances, insomnia, and, rarely, hallucinations. Ask for advice on tapering off gradually if you've been taking it for a long time.

05

Liver: a rare risk to know about

Rare cases of liver injury have been reported with products containing valerian, most often combined with other plants. Causality isn't always established, but this signal justifies not treating concentrated extracts lightly.

06

Pregnancy, children, and duration of use

The EMA advises against valerian-based medicinal products before age 12 as well as during pregnancy and breastfeeding, for lack of sufficient safety data. If symptoms persist after two weeks of continuous use, medical advice is recommended.

Sleep disrupted for several weeks, loud snoring with breathing pauses, marked daytime sleepiness, pain, problematic alcohol use, or a sudden mood change deserve an evaluation rather than a supplement. For an overview of valerian forms and recommendations on chronic insomnia, see also the article Valerian and sleep: forms, evidence and precautions.

07FAQ

01Does valerian really help you sleep? Certain extracts have a recognized use, and participants often report better-quality sleep. This effect hasn't been confirmed by objective measurements, and valerian is not a proven treatment for insomnia.
02Are dry extract and tea the same thing? No. The EMA assigns them different statuses, and concentration and composition vary from one preparation to another.
03Can valerian be combined with a sleeping pill or alcohol? Avoid these combinations without medical or pharmacist advice, and don't drive if you feel drowsy.
04Can you stop it overnight? After short-term use, generally yes. After prolonged use, abrupt discontinuation can cause withdrawal symptoms: ask for advice on tapering gradually.
05Can it be used during pregnancy or breastfeeding? The EMA advises against it for lack of sufficient safety data.

Sources

Peer-reviewed studies and institutional references used for this article.

  1. 1NIH LiverTox
    Other sourceLimited

    database on drug- and herb-induced liver injury

    View source
  2. 2NCCIH (National Center for Complementary and Integrative Health)· 2025
    Official guidelineEstablished

    official summary on the use and safety of valerian

    View source
  3. 3Valente et al., European Neuropsychopharmacology· 2024
    Literature reviewConflicting

    general review of 8 systematic reviews

    View source
  4. 4EMA/HMPC· 2016
    Official guidelineEstablished

    European monograph on valerian root

    View source
  5. 5Miyasaka et al., Cochrane Database of Systematic Reviews· 2006
    Systematic reviewInsufficient

    1 trial included, 36 people with generalized anxiety · 36 participants

    View source

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