Lunixen (Valerian Root Extract)
Herbal medicinal product for mild anxiety and sleep disturbances
Quick Facts About Lunixen
Key Takeaways About Lunixen
- Natural sleep support: Lunixen contains 500 mg of valerian root extract, a well-established herbal remedy for mild sleep disturbances and nervous tension
- Takes time to work: Optimal therapeutic effects are typically achieved after 2–4 weeks of regular use — it is not an immediate-acting sleep aid
- May cause drowsiness: Lunixen can impair driving ability and the operation of machinery — assess your fitness before driving
- Not for everyone: Not recommended during pregnancy, breastfeeding, or for children under 12 years due to insufficient safety data
- Avoid combining with sedatives: Do not take Lunixen alongside other sedating medicines, as the combined effects may be excessive
What Is Lunixen and What Is It Used For?
Lunixen is a herbal medicinal product containing 500 mg of dry valerian root extract (Valeriana officinalis L.) per tablet. It is used for the relief of mild nervous tension (anxiety) and sleep disturbances in adults and adolescents aged 12 years and older. Lunixen is available without a prescription.
Valerian (Valeriana officinalis) is one of the most widely studied herbal remedies for sleep and anxiety worldwide. The root of the valerian plant has been used in traditional European medicine for centuries to promote relaxation and improve sleep quality. Today, valerian root extract is classified as a traditional herbal medicinal product within the European Union, supported by a long history of safe use and a growing body of clinical evidence.
Lunixen contains a concentrated dry extract of valerian root, with each film-coated tablet delivering 500 mg of extract, equivalent to approximately 2–3 g of dried valerian root. The extraction solvent used is ethanol 60% (v/v), which helps isolate the key bioactive compounds believed to contribute to valerian's sedative and anxiolytic properties. These compounds include valerenic acid and its derivatives, which are thought to interact with the gamma-aminobutyric acid (GABA) system in the brain, enhancing GABAergic neurotransmission and producing calming effects.
Lunixen is approved for two primary indications: mild nervous tension (a form of situational or generalised mild anxiety) and sleep disturbances (difficulty falling asleep or maintaining restful sleep). It is important to understand that Lunixen is intended for mild, self-limiting conditions. It is not a substitute for prescription medications in cases of moderate-to-severe anxiety disorders, clinical insomnia, or depression. If symptoms persist or worsen after 2 weeks of regular use, medical advice should be sought.
This medicine is authorised throughout the European Economic Area (EEA) under various brand names. In Finland, Norway, and Sweden it is marketed as Lunixen, while in Belgium, Cyprus, and Luxembourg it is sold as Sedistress Sleep. The marketing authorisation holder is Tilman S.A., based in Baillonville, Belgium, a company specialising in phytotherapy products.
Valerian root extract works differently from conventional sleeping pills. Rather than inducing sedation abruptly, it gently supports the body's natural sleep processes. This means it may take 2–4 weeks of consistent use before you notice the full benefit. Unlike benzodiazepines or Z-drugs, valerian has not been associated with significant tolerance, dependence, or rebound insomnia when discontinued.
What Should You Know Before Taking Lunixen?
Do not take Lunixen if you are allergic to valerian or any of its other ingredients. It is not recommended during pregnancy, breastfeeding, or for children under 12 years. Avoid combining it with other sedative medicines. Lunixen may impair driving ability.
Contraindications
You should not take Lunixen if you have a known allergy (hypersensitivity) to valerian or to any of the other ingredients in the tablet. The inactive ingredients include microcrystalline cellulose, anhydrous calcium hydrogen phosphate, pregelatinised starch, anhydrous colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, indigo carmine aluminium lake (E132), red iron oxide (E172), and black iron oxide (E172). If you have previously experienced an allergic reaction to valerian-containing products, do not use Lunixen.
Allergic reactions to valerian preparations are rare but may present as skin rash, itching, swelling, or gastrointestinal distress. If you suspect an allergic reaction after taking Lunixen, discontinue use immediately and seek medical advice.
Warnings and Precautions
Lunixen may impair your ability to drive vehicles or operate machinery. As a sedative preparation, drowsiness is a normal part of its therapeutic action. You are personally responsible for assessing whether you are fit to drive or perform work that requires alertness. If you feel drowsy, lightheaded, or otherwise impaired after taking Lunixen, refrain from driving or using machinery until the effect has subsided.
This medicine should not be taken in combination with other sedative or sleep-inducing medicines (including over-the-counter products, other herbal sedatives, and prescription sedatives), as the combined effects may be excessively sedating and could increase the risk of adverse effects such as profound drowsiness, impaired coordination, or slowed reflexes.
When consulting a doctor, dentist, or other healthcare professional, always mention that you are taking or have recently taken Lunixen. This is important even though it is an over-the-counter product, because valerian may interact with certain medications or influence the assessment of your symptoms.
Children and Adolescents
Lunixen is not recommended for children under 12 years of age due to a lack of sufficient clinical data on safety and efficacy in this age group. For adolescents aged 12 years and older, the adult dose applies. If you are considering giving Lunixen to an adolescent, it may be prudent to consult a pharmacist or healthcare provider first, particularly if the young person is taking any other medications.
Pregnancy and Breastfeeding
Lunixen is not recommended during pregnancy or breastfeeding. There are insufficient data from clinical studies to rule out harmful effects on the developing baby or the nursing infant. If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, you should consult your doctor or pharmacist before using this medicine.
The European Medicines Agency's Committee on Herbal Medicinal Products (HMPC) has noted that while there is no direct evidence of harm from valerian use during pregnancy, the absence of adequate safety data means that a precautionary approach is warranted. Women who discover they are pregnant while taking Lunixen should discontinue use and discuss alternatives with their healthcare provider.
If you experience symptoms of a severe allergic reaction (such as difficulty breathing, swelling of the face, lips, tongue, or throat, or a widespread rash), stop taking Lunixen immediately and seek emergency medical attention.
How Does Lunixen Interact with Other Drugs?
Lunixen should not be taken with other sedating medications, as the combined effect may cause excessive drowsiness. Always tell your doctor or pharmacist about all medicines you are taking, including herbal supplements and over-the-counter products.
Drug interactions with valerian root preparations are generally considered mild, but certain combinations should be avoided. The primary concern is additive sedation: if you combine Lunixen with another substance that has central nervous system (CNS) depressant effects, the resulting sedation may be greater than expected, potentially impairing your ability to function safely.
Because valerian's mechanism of action involves the GABAergic system, it may theoretically enhance the effects of other GABA-modulating drugs. While large-scale clinical interaction studies with Lunixen specifically are limited, the European Medicines Agency (EMA) recommends caution when combining valerian products with any sedative agent.
Potential Interactions to Be Aware Of
| Drug or Substance | Type of Interaction | Recommendation |
|---|---|---|
| Benzodiazepines (e.g. diazepam, lorazepam) | Additive sedation — increased drowsiness and CNS depression | Avoid combination; consult your doctor |
| Z-drugs (e.g. zolpidem, zopiclone) | Additive sedation — excessive sleepiness | Avoid combination; consult your doctor |
| Antihistamines with sedative effects (e.g. diphenhydramine, hydroxyzine) | Additive sedation — enhanced drowsiness | Use with caution; monitor for excessive drowsiness |
| Alcohol | Additive CNS depression — impaired coordination and judgement | Avoid or minimise alcohol consumption |
| Opioid analgesics (e.g. codeine, tramadol) | Additive sedation — risk of respiratory depression | Avoid combination; consult your doctor |
| Other herbal sedatives (e.g. passionflower, hops, kava) | Additive sedation | Use with caution; consider reducing doses |
| Barbiturates (e.g. phenobarbital) | Additive sedation — significant CNS depression | Avoid combination; consult your doctor |
It is important to note that valerian is unlikely to cause clinically significant interactions with most common medications at standard doses. However, the additive sedation concern is real and clinically relevant. If you are taking any prescription sedative, anti-anxiety medication, or sleep aid, discuss with your healthcare provider before starting Lunixen.
There is currently no strong evidence that valerian significantly affects the cytochrome P450 enzyme system at therapeutic doses, which means it is unlikely to alter the metabolism of most other drugs. However, theoretical concerns have been raised about possible mild inhibition of CYP3A4. Until more data are available, it is prudent to inform your doctor about all medications and supplements you are using.
What Is the Correct Dosage of Lunixen?
For mild anxiety, take 1 tablet up to 3 times daily. For sleep disturbances, take 1 tablet 30–60 minutes before bedtime, with an optional additional tablet earlier in the evening. The maximum daily dose is 4 tablets. Swallow tablets whole with water — do not chew.
Always take Lunixen exactly as described in the patient information leaflet, or as directed by your doctor or pharmacist. The tablets should be swallowed whole with a small amount of water. Do not chew, crush, or break the tablets, as this may affect the release of the active ingredients and alter the taste (valerian has a characteristically strong, earthy flavour).
Adults, Elderly, and Adolescents Over 12 Years
| Indication | Dose | Timing | Notes |
|---|---|---|---|
| Mild anxiety (nervous tension) | 1 tablet | Up to 3 times daily | Space doses evenly throughout the day |
| Sleep disturbances | 1 tablet | 30–60 minutes before bedtime | An additional tablet may be taken earlier in the evening if needed |
| Maximum daily dose | 4 tablets | Per 24-hour period | Do not exceed this dose |
For optimal therapeutic benefit, Lunixen should be taken regularly for 2–4 weeks. The sedative and anxiolytic effects of valerian are cumulative, meaning they build up gradually with consistent use. Some individuals may notice improvements within the first few days, particularly for sleep, but the full benefit is generally achieved after several weeks of uninterrupted therapy.
If your symptoms persist or worsen after 2 weeks of regular use, consult a doctor or pharmacist for further evaluation. Persistent insomnia or anxiety may have underlying causes that require different treatment approaches.
Children Under 12 Years
Lunixen is not recommended for children under 12 years of age. There is insufficient clinical evidence to establish a safe and effective dose for younger children. If a child is experiencing sleep difficulties or anxiety, consult a paediatrician for appropriate assessment and management.
Elderly Patients
No dose adjustment is required for elderly patients. The standard adult dose of 1 tablet applies. However, older adults may be more sensitive to the sedative effects of valerian and should exercise particular caution regarding drowsiness, balance, and fall risk, especially when getting up at night.
Missed Dose
If you forget to take a dose of Lunixen, simply skip the missed dose and take the next one at the usual time. Do not take a double dose to make up for a forgotten one. Taking extra tablets will not improve the therapeutic effect and may increase the risk of side effects such as gastrointestinal discomfort or excessive drowsiness.
Overdose
If you take more Lunixen than recommended, or if a child accidentally ingests the medicine, contact a doctor, hospital, or your local poison control centre immediately for risk assessment and advice.
Symptoms of valerian overdose may include:
- Excessive tiredness or drowsiness
- Abdominal cramps
- Chest tightness
- Dizziness or lightheadedness
- Hand tremors
- Dilated pupils (mydriasis)
These symptoms are generally self-limiting and resolve as the body metabolises and eliminates the excess valerian. However, medical evaluation is recommended, especially if large quantities have been consumed or if the person is a child. Treatment is supportive and symptomatic.
No withdrawal effects or rebound symptoms are expected when you stop taking Lunixen. However, the symptoms of anxiety or sleep disturbance that led you to start the medicine may return. If this happens, you may resume treatment or discuss alternative approaches with your healthcare provider.
What Are the Side Effects of Lunixen?
Valerian preparations, including Lunixen, may cause gastrointestinal symptoms such as nausea and stomach cramps. The exact frequency of these side effects is not known. Most people tolerate Lunixen well, and serious adverse effects are very rare.
Like all medicines, Lunixen can cause side effects, although not everybody gets them. Valerian root preparations have a long history of traditional use and are generally regarded as well-tolerated. The most commonly reported adverse effects in clinical studies and post-marketing surveillance are gastrointestinal in nature.
Because Lunixen is a single-ingredient herbal product with a relatively limited formal clinical trial database (compared to synthetic pharmaceuticals), the precise frequency of side effects has not been determined using large randomised controlled trials. The European Medicines Agency classifies the frequency of these effects as “not known” (frequency cannot be estimated from the available data).
Frequency Not Known
Cannot be estimated from available data
- Nausea
- Stomach cramps or abdominal pain
- Gastrointestinal discomfort
Additional effects that have been reported anecdotally or in isolated case reports with valerian products in general (not necessarily specific to Lunixen) include headache, dizziness, and vivid dreams. These are generally mild and transient, resolving upon dose reduction or discontinuation.
It is worth noting that drowsiness, while often perceived as a side effect, is actually part of the intended pharmacological action of Lunixen when used for sleep disturbances. If daytime drowsiness persists and interferes with your daily activities, consider taking the medicine only at bedtime or discuss the timing of doses with your pharmacist.
When to Seek Medical Advice
You should contact your doctor or pharmacist if you experience:
- Persistent or severe gastrointestinal symptoms
- Signs of an allergic reaction (skin rash, itching, swelling, difficulty breathing)
- Any other unexpected or bothersome symptoms
Reporting Side Effects
If you experience side effects from Lunixen, you can report them to your national medicines agency. Reporting side effects helps improve the safety information available for all medicines and contributes to a better understanding of the benefit–risk profile. In many countries, both patients and healthcare professionals can submit reports online or by post.
How Should You Store Lunixen?
Store Lunixen in its original packaging, out of the reach and sight of children. Protect from moisture. No special temperature requirements. Do not use after the expiry date printed on the packaging.
Proper storage of medicines is essential to maintain their quality, safety, and effectiveness throughout the shelf life. Lunixen should be stored according to the following guidelines:
- Keep out of sight and reach of children. Store the medicine in a secure location where children cannot access it, such as a locked medicine cabinet or a high shelf.
- Store in the original packaging. The blister pack protects the tablets from moisture and light. Do not remove tablets from the blister until you are ready to take them.
- Protect from moisture. Valerian extract is sensitive to humidity, which can affect the quality of the tablet. Avoid storing the medicine in bathrooms or other humid environments.
- No special temperature requirements. Lunixen can be stored at room temperature. However, avoid exposing it to extreme heat (e.g. direct sunlight, car glove compartment in summer) or extreme cold.
- Check the expiry date. The expiry date (marked “EXP” on the packaging) refers to the last day of the indicated month. Do not use Lunixen after this date.
Do not dispose of medicines via household waste or by flushing them down the toilet. Return unused or expired medicines to your pharmacy for proper disposal. This helps protect the environment from potential contamination with pharmaceutical residues.
What Does Lunixen Contain?
Each Lunixen tablet contains 500 mg of dry valerian root extract (Valeriana officinalis L.), equivalent to 2–3 g of dried valerian root. The extraction solvent is 60% ethanol. The tablets also contain inactive ingredients for structural integrity and film-coating.
Active Ingredient
The active substance is dry extract of valerian root (Valeriana officinalis L.). Each film-coated tablet contains 500 mg of this extract, which is equivalent to 2–3 g of the crude (dried) valerian root. The drug-to-extract ratio reflects a concentrated preparation designed to deliver a therapeutically relevant dose of the key bioactive compounds found in valerian root, including valerenic acid, isovaleric acid, and various iridoids.
The extraction solvent used during manufacturing is ethanol 60% (v/v). This concentration of ethanol is optimal for extracting both the polar and non-polar components of the valerian root, ensuring a balanced phytochemical profile in the final product.
Inactive Ingredients (Excipients)
The inactive ingredients serve various pharmaceutical functions, including binding, filling, lubricating, and coating the tablet:
Tablet core:
- Microcrystalline cellulose (binder/filler)
- Anhydrous calcium hydrogen phosphate (filler)
- Pregelatinised starch (binder/disintegrant)
- Anhydrous colloidal silicon dioxide (glidant)
- Magnesium stearate (lubricant)
Film coating:
- Polyvinyl alcohol (film former)
- Titanium dioxide — E171 (opacifier/whitener)
- Macrogol (plasticiser)
- Talc (anti-tacking agent)
- Indigo carmine aluminium lake — E132 (blue colourant)
- Red iron oxide — E172 (colourant)
- Black iron oxide — E172 (colourant)
Appearance and Pack Sizes
Lunixen tablets are light blue, oblong, biconvex film-coated tablets measuring approximately 18 × 7 mm. They are packaged in PVC/PE/PVDC/aluminium blister packs. Available pack sizes include 28 tablets, 56 tablets, and unit-dose blisters of 100 × 1 tablets. Not all pack sizes may be marketed in every country.
Frequently Asked Questions About Lunixen
Lunixen is a herbal medicinal product used for the relief of mild nervous tension (anxiety) and sleep disturbances. It contains 500 mg of dry valerian root extract per tablet and is suitable for adults and adolescents over 12 years. It is available over-the-counter and does not require a prescription.
For sleep disturbances, you should take Lunixen 30–60 minutes before bedtime. While some people notice improvements within the first few days, the full therapeutic effect typically develops after 2–4 weeks of regular, consistent use. Valerian works by gradually supporting the body's natural sleep and relaxation mechanisms rather than inducing immediate sedation.
No, Lunixen is not recommended during pregnancy or breastfeeding due to insufficient safety data. While there is no direct evidence of harm, there are not enough clinical studies to confirm that valerian is safe for the developing baby or nursing infant. If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist for alternative approaches to managing sleep or anxiety.
Yes, Lunixen may impair your ability to drive or operate machinery. Drowsiness is part of its intended therapeutic effect, particularly when used as a sleep aid. You are responsible for assessing whether you are fit to drive. If you feel drowsy, lightheaded, or otherwise impaired, do not drive or operate machinery until the effects have worn off.
Lunixen should not be combined with other sedating medicines, including benzodiazepines, Z-drugs, sedative antihistamines, or opioid painkillers, due to the risk of additive sedation. You should also be cautious with alcohol. Always inform your doctor or pharmacist about all medicines and supplements you are taking before starting Lunixen.
No, valerian root extract has not been associated with significant tolerance, physical dependence, or addiction in clinical studies. Unlike benzodiazepines or Z-drugs, you can discontinue Lunixen without experiencing withdrawal symptoms or rebound insomnia. However, the underlying symptoms (anxiety or sleep disturbances) may return after stopping the medication.
References and Sources
This article is based on the approved product information for Lunixen as well as international clinical guidelines and peer-reviewed research on valerian (Valeriana officinalis). All content has been reviewed according to evidence-based medical standards.
- European Medicines Agency (EMA). Community herbal monograph on Valeriana officinalis L., radix. HMPC Assessment Report. EMA/HMPC/150848/2017.
- Bent S, Padula A, Moore D, Patterson M, Mehling W. “Valerian for sleep: a systematic review and meta-analysis.” American Journal of Medicine. 2006;119(12):1005–1012. doi:10.1016/j.amjmed.2006.02.026
- Fernandez-San-Martin MI, Masa-Font R, Palacios-Soler L, et al. “Effectiveness of Valerian on insomnia: a meta-analysis of randomized placebo-controlled trials.” Sleep Medicine. 2010;11(6):505–511. doi:10.1016/j.sleep.2009.12.009
- World Health Organization (WHO). WHO Monographs on Selected Medicinal Plants — Volume 1: Radix Valerianae. Geneva: WHO; 1999.
- European Pharmacopoeia. Valerian Root (Valerianae radix). European Directorate for the Quality of Medicines (EDQM).
- Shinjyo N, Waddell G, Green J. “Valerian Root in Treating Sleep Problems and Associated Disorders — A Systematic Review and Meta-Analysis.” Journal of Evidence-Based Integrative Medicine. 2020;25:2515690X20967323. doi:10.1177/2515690X20967323
- National Institutes of Health (NIH), Office of Dietary Supplements. Valerian Fact Sheet for Health Professionals. Updated 2023.
- British National Formulary (BNF). Valerian. National Institute for Health and Care Excellence (NICE).
Editorial Team
iMedic Medical Editorial Team — specialists in pharmacology and clinical medicine with extensive experience in evidence-based medication information.
iMedic Medical Review Board — an independent panel of physicians and pharmacists who review all content according to WHO, EMA, and HMPC guidelines.
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