Valerianae extract

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Valerianae extract

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Method of action: Antispasmodic, Hypnotic, Sedative

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Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Valerianae extract

Property Description
Active ingredient Valerenic acid and derivatives, Valepotriates
Form Tablets, Capsules, Tincture, Liquid extract
Pharmacological class Sedative, Anxiolytic
Common use Relieving nervous tension and sleep support
Origin Natural (Valeriana officinalis rhizomes and roots)

What Type of Medicine is Valerianae Extract?

Valerianae extract is classified as a phytotherapeutic medicine, meaning it's an herbal medicinal product derived from natural plant sources rather than synthetic chemicals. This preparation specifically originates from the underground structures—the rhizomes and roots (Valerianae Officinalis Rhizomata Cum Radicibus) of the common Valeriana officinalis plant, establishing its identity as a drug of natural origin. Valerian root preparations are clinically recognized as traditional herbal medicinal products for specific indications. This confirms the extract’s history of traditional use for easing mild symptoms of nervous tension and aiding sleep.


Composition and Available Forms of the Extract

The extract's biological activity is attributed not to a single chemical, but to characteristic constituents, primarily sesquiterpenoids like Valerenic acid and its derivatives, along with Valepotriates. This complex composition is a key differentiating feature from single-molecule synthetic agents. The extract is administered orally in various dosage form(s), most commonly as compressed tablets, capsules, or liquid preparations like tinctures. The final form involves either a concentrated dry extract combined with pharmaceutical excipients for solid forms, or a liquid where the active compounds are dissolved in an appropriate solvent, often an aqueous-alcoholic base.


Pharmacological Class and General Purpose (Sedative/Anxiolytic)

Valerianae extract is primarily categorized by its function as a high-level sedative and anxiolytic agent. Its general purpose is to help relieve symptoms associated with nervous tension and provide support for sleep disorders. The compounds in Valerian exert a modulatory effect on the brain's GABAergic system. This indicates that the compounds gently influence inhibitory signals in the central nervous system, promoting a state of natural restfulness and mental tranquility. This action supports restfulness without detailing specific conditions or regimens.

Regulatory References

  1. EMA's Valerian page
  2. NIH Fact Sheet

What side effects are possible with Valerianae extract?

Possible Side Effects and Safety Information

The safety profile for Valerianae extract is based on clinical reports and regulatory documents, primarily related to its traditional use as a sedative.


Documented Adverse Reactions

The most commonly reported adverse reactions are generally mild and transient, affecting the Gastrointestinal and Nervous Systems. These may include stomach upset, nausea, abdominal cramps, dizziness, headache, and residual drowsiness or mental dullness the day following use.

In rare instances, regulatory authorities have documented reports of liver injury (hepatotoxicity). Individuals experiencing symptoms such as yellowing of the skin or eyes (jaundice), dark urine, unusual fatigue, or abdominal pain should discontinue use and seek immediate medical attention.


Safety Considerations and Restrictions

Drowsiness Risk: Due to the risk of drowsiness, individuals should not drive or operate heavy machinery after using Valerianae extract. The sedative effects may be intensified by alcohol or other central nervous system (CNS) depressants.

Withdrawal: Abrupt cessation following prolonged, high-dose consumption has rarely been associated with withdrawal symptoms, including delirium and heart disturbances, indicating the importance of avoiding excessive use and consulting a professional for discontinuation after chronic intake.

Population-Specific Use: Use is generally not recommended for children under the age of 12 or 18 (depending on the national regulatory guidance) due to insufficient safety data. Use is also contraindicated during pregnancy and breast-feeding as safety in these populations has not been established.

Overdose and Emergency Response

The official regulatory profile for Valerianae extract overdose describes acute effects primarily involving the Central Nervous System (CNS). Documented manifestations include excessive sedation resulting in unusual tiredness, mental dullness, and stupor. Gastrointestinal symptoms such as upset stomach and stomach cramping have also been reported in overdose cases.

While severe outcomes are generally rare, regulatory documents acknowledge the potential for hepatotoxicity (liver injury), which is considered a serious systemic complication. Symptoms of potential liver issues, such as jaundice (yellowing of the skin or eyes) or dark urine, necessitate immediate action.

Immediate Actions and Management

Individuals must seek emergency medical attention or contact a poison control center immediately if overdose is suspected. Urgent medical follow-up is also required if any sign of potential liver injury is observed, and the use of the extract must be stopped at once. Treatment for overdose is officially defined as symptomatic and supportive treatment, as regulatory information explicitly states that no specific antidote is known for this extract. Hospital observation may be required in cases of severe effects or co-ingestion with other sedatives.

Official Overdose Statements:

  • Overdose primarily results in central nervous system depression, including mental dullness and stupor.
  • The rare, but serious, risk of hepatotoxicity requires immediate medical intervention upon symptom detection.
  • Treatment is supportive and symptomatic, and no specific antidote is available.

Connection to the Overall Overdose Profile

Regulatory documents define the Valerianae extract overdose profile by focusing on the acute effects of CNS depression and the need for immediate action to rule out severe systemic complications. This guidance focuses entirely on emergency contact and supportive care.

Therapeutic Uses of Valerianae extract

What Valerianae Extract is Used for: Therapeutic Uses

Valerianae extract is commonly used in therapeutic domains involving mild episodic or fluctuating mental and emotional tension. The extract is applied to help manage symptom clusters that create noticeable functional strain, and is applied as supportive assistance for sleep disturbances and nervous restlessness.


Support for Tension and Sleep Difficulties

This preparation is relevant in situations where supportive symptom management is appropriate for conditions characterized by periods of heightened symptoms. The extract is used to manage difficulties with prolonging the time needed to fall asleep and experiencing fragmented sleep at night, symptoms which often interfere with daily comfort. It is commonly used when short-term symptomatic assistance is needed.

The application provides supportive relief that may help patients cope more steadily with symptom fluctuations. The application supports promoting natural restfulness and assists with maintaining functional stability.

“The extract is applied to manage symptom patterns characteristic of general, non-pathological tension.”

Quick Fact: Support for Nervous Restlessness


Use in Specific Symptom-Driven Contexts

Valerianae extract is generally considered relevant for addressing symptom patterns associated with specific patient groups, such as the mild sleep disturbances and nervous symptoms often accompanying menopausal shifts or periods of stress in adolescents over 12 years old. This use contributes to improved day-to-day comfort during symptomatic periods.

Regulatory References

  1. European Medicines Agency's Committee on Herbal Medicinal Products (HMPC)

Eligibility and Restrictions for Use

Regulatory documents establish clear eligibility criteria and restrictions for the use of valerian root extract.

Official Eligibility and Contraindications

Population Group Eligibility Status (Regulatory) Rationale/Condition
Adults and Adolescents Generally Allowed Minimum age is typically 12 years and older; some labels specify 18 years and older.
Children Not Recommended Use in children under 12 years is not established due to a lack of adequate safety data.
Pregnant/Breastfeeding Women Not Recommended Safety has not been established; use is discouraged in the absence of sufficient data.
Hypersensitivity Contraindicated Prohibited for individuals with known allergy to valerian root or any other ingredient in the product.
Alertness/Driving Use Restricted Patients should not drive or operate machinery if affected by drowsiness or dizziness.

Official regulatory sources specify that use is contraindicated in cases of hypersensitivity. Furthermore, due to the lack of established safety data, the product is not recommended for women who are pregnant or breastfeeding, which serves as a significant exclusion for this population. The eligibility profile also includes a Special Warning regarding potential drowsiness, advising against use when high mental alertness is required. Use in children under 12 years of age is consistently not recommended in official labeling across various regulatory agencies.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The regulatory interaction profile for Valerianae extract is defined by a primary pharmacodynamic risk of enhanced Central Nervous System (CNS) depression when combined with other agents that cause sedation. Co-administration with prescribed medicines such as hypnotics, sedatives, barbiturates, and benzodiazepines (e.g., Diazepam) may result in additive effects, as documented in official government sources.

This pharmacodynamic risk necessitates a strict restriction against combining the extract with alcohol (ethanol) and requires caution when co-administered with other sedating herbal products like Kava or Melatonin.

A mandatory timing requirement is placed on the use of the extract in the perioperative context. Due to the potential interaction with general anesthetics, Valerianae extract must be discontinued at least one to two weeks prior to any scheduled surgical procedure.

Regarding metabolic processes, official regulatory assessments confirm that clinically relevant pharmacokinetic interactions with the major hepatic Cytochrome P450 (CYP) enzymes, including CYP 2D6 and CYP 3A4, have not been observed. This structure highlights that risk management is predominantly focused on the additive sedative effects.

Mechanism of Action

Mechanism of Action

Valerianae extract exerts its primary action in the central nervous system through components like valerenic acid, which functions as a Positive Allosteric Modulator of the Gamma-Aminobutyric Acid ( GABA A) receptor complex . By binding to an allosteric site, valerenic acid enhances the inhibitory effect of endogenous GABA. This molecular interaction increases the conductance of the receptor's chloride ion channel, resulting in a greater influx of chloride ions ( Cl^-) into the postsynaptic neuron. The subsequent hyperpolarization of the neuronal membrane dampens the firing rate and overall excitability of nerve cells.

Secondary actions involve partial agonism at 5- HT5 A serotonin receptors and potential inhibition of the GABA Transporter (GAT-1). Modulating these systems reinforces the inhibitory signal and influences the circuits regulating sleep-wake transitions. Collectively, these actions produce a systemic physiological state characterized by diminished neural excitability and a resultant reduction of muscle tone.

Dosage and Administration Information

The administration of Valerianae extract follows standard protocols detailing its route, dose, and duration.

Entity Administration Principle
Route and Forms Administration is primarily oral, encompassing solid forms (tablets, capsules), liquid preparations, and herbal tea infusions. It is also utilized for topical use as a bath additive.
Dosing Schedule For adults, a single oral dose of standardized dry extract typically ranges from 400 mg to 600 mg. For bath additive use, 100 g of the comminuted substance is utilized for a full bath.
Frequency and Timing For the relief of nervous tension, administration is divided, with doses taken up to three times daily. For use in sleep support, a single dose is directed to be taken half to one hour before scheduled bedtime.
Age and Exclusion Standard dosing is applied to adults and adolescents over 12 years of age. Use is not recommended in children under 12 years of age due to a lack of established data.

The preparation is not intended for acute interventional treatment due to its gradual procedural effect. Standard protocols specify that continued use over 2 to 4 weeks is required to achieve the optimal procedural effect. If the desired outcome is not observed or if conditions persist after two weeks, a review of administration is warranted. These parameters establish a clear distinction between the single nightly dose for sleep and the divided daily use for tension, defining the use protocol for this phytotherapeutic medicine.

Recent Clinical Evidence

Research evidence / Overview of studies for Valerianae extract

Evidence for use in Sleep Difficulties and Disturbances

Research examining Valerianae extract for sleep complaints has primarily focused on randomized controlled trials (RCTs) and meta-analyses that pool data from multiple studies. Research has utilized objective monitoring devices, such as polysomnography, alongside studies examining patient-reported experiences to measure sleep parameters over defined time intervals. The main outcomes studies monitored include Subjective Sleep Quality, the time to fall asleep (Sleep Latency), and the total time spent asleep. Studies monitored outcomes in Adults experiencing general sleep disturbances and self-reported poor sleepers.

Studies reported patterns where some patients described changes in their perceived discomfort related to poor sleep quality. However, when examining objective data gathered during the study period, the findings were mixed, and definitive uniform patterns of change were not consistently documented across all trials. The evidence contributes to the broader evidence landscape regarding short-term symptom changes. Regulatory reviews have noted that objective measurements of sleep parameters were not always aligned with patient-reported outcomes.

Evidence for use in Mild Nervous Tension and Restlessness

Research explored the extract's use for symptoms of mild nervous tension and restlessness, examining outcomes related to physiological strain or stress. The research, which includes RCTs and systematic reviews, was evaluated in patient groups experiencing fluctuating or episodic manifestations of emotional tension. Studies monitored scores on specific anxiety scales documented via psychological rating scales. Trials monitored tension and anxiety scores over assessment periods, with some reports indicating variations in these subjective outcomes. However, the evidence is limited for this indication when studied as an isolated primary outcome, separate from accompanying sleep disturbances.

Long-Term Follow-up and Duration of Study

The majority of research exploring Valerianae extract involves assessments over defined time intervals that are generally considered short-term to intermediate. Trials typically involve follow-up durations that are limited, often lasting only for a few weeks, such as 14 to 56 days. There is limited information for long-term outcomes or the durability of any observed symptom patterns beyond the study period. Long-term effects are not well characterized by existing regulatory or peer-reviewed literature.

Frequently Asked Questions (FAQ)

Common questions about Valerianae extract (FAQ)


Q: Can Valerianae extract be taken during the daytime for general nervousness or mild anxiety?

A: Official guidelines describe the use of Valerianae extract for the relief of mild nervous tension, noting that doses may be taken up to three times daily, which aligns with the official use protocol for tension relief. Due to the known sedative effects, official warnings state restrictions apply to activities like driving or operating heavy machinery.

Q: Does Valerianae extract address both difficulty falling asleep and difficulty staying asleep?

A: Regulatory documents indicate that research into Valerianae extract for sleep disturbances has monitored outcomes related to both the time taken to fall asleep (sleep latency) and the total duration of sleep. The fact that studies monitor both parameters confirms evaluation of effects on both initiating and maintaining sleep.

Q: How long does it generally take before a person might notice the intended effects of Valerianae extract?

A: Official guidance indicates that the preparation is not intended for acute intervention, meaning it does not work instantly after a single dose. To achieve the optimal procedural effect, continued use over a period of 2 to 4 weeks is generally required.

Q: Is Valerianae extract expected to work when taken only once, or does it require continuous use?

A: Administration instructions define a single nightly dose for sleep support. However, official guidance also states that continued use over 2 to 4 weeks is necessary to achieve the optimal procedural effect. This indicates that achieving the optimal procedural effect requires a gradual process over time, based on continuous use rather than a single acute dose.

Q: How does Valerianae extract differ from prescription sleep medications in terms of its general effects?

A: Valerianae extract is officially classified as a phytotherapeutic medicine, which is an herbal medicinal product derived from natural plant sources. This extract contains a complex composition of active constituents, which generally distinguishes it from synthetic single-molecule agents, such as many prescription sleep medications.

Q: What is the process for safely stopping Valerianae extract after long-term use to avoid potential withdrawal symptoms?

A: Regulatory safety information notes that abrupt cessation following prolonged, high-dose consumption has been rarely associated with withdrawal symptoms. Official guidance notes the importance of seeking consultation with a healthcare professional regarding discontinuation after chronic intake.

Q: Are there known interactions between Valerianae extract and medications that are broken down by the liver?

A: Official regulatory assessments confirm that clinically relevant pharmacokinetic interactions with the major hepatic Cytochrome P450 (CYP) enzymes have not been observed with Valerianae extract. These enzymes are responsible for breaking down many other medications in the liver.

Q: Is it generally safe for older adults to use Valerianae extract?

A: Regulatory guidance defines specific populations where use is contraindicated, such as children under 12 and pregnant or breastfeeding women. Older adults are not specifically excluded from use, but general warnings regarding potential drowsiness remain relevant.

Q: Can Valerianae extract cause agitation or restlessness in some people, rather than a calming effect?

A: The majority of documented adverse reactions are generally mild, primarily affecting the nervous system (e.g., dizziness or headache). While the primary effect is calming, some reports in the broader safety literature mention the occasional occurrence of symptoms like sleeplessness or restlessness.

Q: What are the historical uses of Valerianae extract outside of modern sleep support?

A: Historical accounts from authoritative sources like the National Institutes of Health (NIH) indicate that Valerianae extract has been traditionally used since ancient times. Past applications include use for nervousness, trembling, headaches, and relieving stress.

Q: Why is Valerianae extract often included in combination products with other herbs like hops or lemon balm?

A: Regulatory assessments note the extract's complex composition and assume a possible synergistic action between its multiple components. This potential for synergistic action is the basis for combining it with other botanicals often noted for sedative and anxiolytic effects.

Q: What is the available evidence regarding Valerianae extract and potential mild liver issues?

A: Regulatory authorities have documented reports of liver injury (hepatotoxicity) occurring in rare instances following use. Regulatory documents note that use must be discontinued immediately if symptoms such as jaundice (yellowing of the skin or eyes) or dark urine are experienced.

Q: Are there any reported side effects related to the heart, such as palpitations or heart rate changes?

A: Regulatory-cited literature primarily documents effects on the Gastrointestinal and Nervous Systems. While cardiovascular changes are not common adverse reactions, some historical accounts mention its traditional use for related concerns such as heart palpitations.

Q: What general categories of over-the-counter (OTC) medicines might interact with Valerianae extract?

A: The primary interaction risk is described as a pharmacodynamic risk of enhanced Central Nervous System (CNS) depression. The potential for enhanced CNS depression exists when Valerianae extract is combined with any other over-the-counter agent that causes a sedative effect, such as certain allergy or cold medicines.

Q: Should Valerianae extract be avoided if a person is also taking anti-anxiety or antidepressant medication?

A: Official warnings describe the risk associated with co-administration alongside prescribed medicines such as hypnotics and sedatives, including benzodiazepines (a class of anti-anxiety medication). This caution is due to the pharmacodynamic risk of enhanced Central Nervous System (CNS) depression.

Q: Does Valerianae extract affect how narcotic pain medications work in the body?

A: Official warnings advise against combining Valerianae extract with other medicines that cause Central Nervous System (CNS) depression due to a risk of additive sedative effects. Many narcotic pain medications fall into this official category of CNS depressants.

Q: Are there any specific foods or drinks that should be avoided when taking Valerianae extract?

A: Regulatory guidance specifies a strict restriction against combining the extract with alcohol (ethanol) due to the pharmacodynamic risk of enhanced Central Nervous System (CNS) depression. Other specific food or drink restrictions are not generally mentioned in the official product information.

Q: What does the term 'subjective improvement' mean when discussing Valerianae extract research findings?

A: In research on Valerianae extract, subjective improvement refers to patient-reported outcomes, such as changes in perceived sleep quality or reported discomfort levels. Regulatory reviews note that these patient reports have not always aligned with objective measurements gathered during clinical trials.

Q: Are there specific components in the Valerianae plant that researchers believe are responsible for its effects?

A: The extract's biological activity is attributed to characteristic constituents, primarily sesquiterpenoids like Valerenic acid and its derivatives, along with Valepotriates. These compounds are considered the key components that contribute to the extract's sedative and anxiolytic effects.

Q: Is the whole Valerianae root extract generally considered more reliable than single isolated components?

A: Regulatory assessments indicate that the extract's biological activity is attributed to a complex composition, where a possible synergistic action of multiple components is assumed. For this reason, official reports often designate the whole extract as the active ingredient, rather than focusing solely on a single isolated compound.

Q: Has Valerianae extract been studied for reducing symptoms of premenstrual syndrome (PMS)?

A: Some research studies cited in authoritative databases have examined the use of Valerianae extract for supporting symptoms related to premenstrual syndrome (PMS). These studies looked at reducing emotional, physical, and behavioral symptoms associated with the condition.

Q: Is it possible to experience vivid or strange dreams while using Valerianae extract?

A: The broader safety literature, including sources published by the NIH, notes that vivid dreams have been reported as a possible, though generally mild, side effect. This is categorized alongside other adverse reactions affecting the nervous system.

Q: Is there research evidence that Valerianae extract can help with symptoms related to menopause?

A: Research has explored the use of Valerianae extract for supporting symptoms related to menopause. Some studies have examined outcomes such as the reduction in the frequency and severity of hot flashes.

How should Valerianae extract be stored and disposed of?

How to Store and Dispose of Valerianae Extract

The storage and disposal of Valerianae extract must comply with regulatory requirements to preserve product quality and safety.


Storage Conditions

Official labeling requires the product to be stored at room temperature and protected from moisture. The container must be kept tightly closed to maintain product integrity. Crucially, the medicine must be stored out of the sight and reach of children to prevent accidental ingestion.


Disposal Instructions

Any unused or expired Valerianae extract must be safely discarded after the expiration date. Disposal procedures should always follow local regulations for medicine waste to ensure proper handling and prevent environmental contamination.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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