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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brand Name
Valeriana E Rad. 3
Generic Name
Valeriana E Rad. 3
Active Ingredient
ValerianCategory
Non-Standardized Food Allergenic Extract [EPC]
Variants
1
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 3 [hp_X]/mL | LIQUID | ORAL | 48951-9036 |
Detailed information about Valeriana E Rad. 3
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Valeriana E Rad. 3, you must consult a qualified healthcare professional.
Valerian (Valeriana officinalis) is a botanical agent primarily utilized for its sedative and anxiolytic properties. It is classified under various EPC categories including Non-Standardized Plant Allergenic Extracts and Nitrate Vasodilators, often used for sleep and stress management.
The dosage of Valerian can vary significantly based on the condition being treated and the concentration of the specific extract used. Patients should always consult the product label and their healthcare provider, as 'standard' doses are not universally defined for herbal products.
Valerian is generally not recommended for use in children under the age of 12 without direct medical supervision. There is a lack of robust clinical data regarding the long-term safety and neurodevelopmental impact of Valerian in pediatric populations. If a healthcare provider deems it necessary for an older child (ages 12-18), the dose is typically adjusted based on body weight, often starting at 1/4 to 1/2 of the adult dose.
There are no specific guidelines for Valerian dosage in patients with kidney disease. However, since metabolites are excreted renally, patients with a GFR below 30 mL/min should use Valerian with caution and monitor for increased sedation or cognitive impairment.
Valerian is metabolized by the liver. Patients with cirrhosis or significant hepatic dysfunction should avoid Valerian or use it only under strict medical supervision, as there have been rare reports of hepatotoxicity associated with multi-ingredient Valerian preparations.
Older adults should start at the lowest possible dose (e.g., 150 mg for sleep). The elderly are more susceptible to the CNS-depressant effects of Valerian, which can increase the risk of confusion, dizziness, and falls, particularly if they are already taking other medications.
To maximize the efficacy and safety of Valerian, follow these specific administration instructions:
If you miss a dose of Valerian, take it as soon as you remember. However, if it is nearly time for your next scheduled dose (or if you are taking it for sleep and it is already morning), skip the missed dose and resume your regular schedule. Do not double the dose to make up for a missed one, as this increases the risk of next-day grogginess.
While Valerian has a high margin of safety, an overdose can occur if extremely large quantities are consumed. Signs of overdose may include:
In the event of a suspected overdose, contact your local poison control center or seek emergency medical attention immediately. Treatment is generally supportive, focusing on maintaining airway patency and hydration.
> Important: Follow your healthcare provider's dosing instructions. Do not adjust your dose or combine Valerian with other sedatives without medical guidance.
Most individuals tolerate Valerian well, but some may experience mild side effects. These are typically transient and resolve as the body adjusts to the supplement. Common reactions include:
> Warning: Stop taking Valerian and call your doctor immediately if you experience any of these serious symptoms:
Data on the long-term use of Valerian (exceeding 6 months) is limited. Some clinicians express concern regarding the potential for 'Valerian withdrawal' if high doses are used for years and then stopped abruptly. Symptoms might include anxiety and rapid heart rate. Additionally, chronic use may lead to a mild psychological dependence on the supplement for sleep initiation. There is also the theoretical risk of 'downregulation' of GABA receptors with perpetual use, though this has not been definitively proven in human clinical trials.
There are currently no FDA black box warnings for Valerian. Unlike many prescription sedative-hypnotics (such as benzodiazepines or 'Z-drugs'), Valerian does not carry a high risk of respiratory depression or fatal overdose when used alone. However, its classification as a dietary supplement means it has not undergone the same rigorous safety labeling process as pharmaceutical drugs.
Report any unusual symptoms to your healthcare provider. Keeping a 'symptom diary' can help your doctor determine if Valerian is the cause of any new health issues.
Valerian is a potent pharmacological agent despite its botanical origin. It should be treated with the same respect as any prescription medication. The primary safety concern is its additive effect when combined with other central nervous system (CNS) depressants. Patients must be aware that Valerian can significantly impair cognitive and motor functions, especially during the first few days of treatment or following a dose increase.
No FDA black box warnings for Valerian. It is generally recognized as safe (GRAS) by the FDA for use in foods, though its use as a concentrated supplement requires more careful consideration.
For most healthy individuals, routine lab testing is not required for short-term Valerian use. However, for those using it chronically or at high doses, healthcare providers may recommend:
Valerian causes drowsiness and can significantly slow reaction times. Do not drive, operate heavy machinery, or engage in hazardous activities for at least 8 to 12 hours after taking a dose. The 'residual' effects of Valerian can persist into the next morning, even if you feel alert.
Alcohol must be strictly avoided while taking Valerian. Both substances act as CNS depressants and enhance GABAergic activity. Combining them can lead to dangerous levels of sedation, respiratory depression, and impaired judgment. This combination also increases the metabolic load on the liver.
If you have been taking Valerian daily for more than a few weeks, do not stop taking it suddenly. While not as habit-forming as prescription sedatives, abrupt cessation can cause 'rebound insomnia' or mild anxiety. A gradual taper—reducing the dose over 1 to 2 weeks—is the safest way to discontinue use.
> Important: Discuss all your medical conditions with your healthcare provider before starting Valerian. A full medical history is necessary to ensure safety.
Valerian should never be combined with certain medications due to the risk of severe, life-threatening CNS depression or toxicity:
Valerian is not known to interfere with most standard blood chemistry or hematology tests. However, because it is a Non-Standardized Plant Allergenic Extract [EPC], it may interfere with skin prick testing for allergies. If you are undergoing allergy testing, inform your immunologist that you are taking Valerian, as it may cause a false-positive or false-negative result depending on the specific test panel.
For each major interaction, the mechanism usually involves pharmacodynamic synergy (both drugs doing the same thing to the brain) or pharmacokinetic inhibition (Valerian slowing down the liver's ability to clear other drugs). The clinical consequence is almost always an increase in side effects or toxicity. The best management strategy is to avoid these combinations or have your doctor closely monitor your therapy.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking. Even 'natural' products can have dangerous interactions.
Valerian must NEVER be used in the following circumstances:
These conditions require a careful risk-benefit analysis by a healthcare professional:
Patients who are allergic to other members of the Caprifoliaceae family (which now includes the former Valerianaceae) may exhibit cross-sensitivity. Additionally, since Valerian is classified as a Non-Standardized Insect Allergenic Extract [EPC] in some contexts of cross-reactivity research, individuals with severe environmental allergies should be cautious when first starting Valerian, as botanical extracts often contain trace amounts of pollen or other environmental proteins.
> Important: Your healthcare provider will evaluate your complete medical history before prescribing or recommending Valerian. Never start this supplement if you have any of the absolute contraindications listed above.
Valerian is generally classified as Category B or C (depending on the specific international regulatory body), meaning that animal studies have either not shown risk or are unavailable, and human studies are lacking. There is a theoretical risk that Valerian could cross the placenta and affect the developing fetal nervous system. Because sleep disturbances in pregnancy can often be managed with safer behavioral interventions (like sleep hygiene), most obstetricians recommend avoiding Valerian during all trimesters of pregnancy.
It is unknown whether the active constituents of Valerian, such as valerenic acid, pass into human breast milk. However, many small-molecule phytochemicals do. There is a risk that a nursing infant could experience sedation, poor feeding, or lethargy if the mother takes Valerian. Until more data is available, Valerian is not recommended for use while breastfeeding. If use is essential, the infant must be closely monitored for excessive sleepiness.
Valerian is not FDA-approved for use in children. While some European monographs allow for its use in children over 12 for 'nervous tension,' the safety profile in younger children is entirely unknown. There is particular concern regarding the effect of GABA-modulating agents on the developing brain. Valerian should only be used in pediatric patients under the direct supervision of a pediatric specialist.
The elderly are at a significantly higher risk for adverse effects from Valerian. Age-related declines in hepatic and renal function can lead to higher-than-expected blood levels. The primary concerns in this population are:
In patients with chronic kidney disease (CKD), the excretion of Valerian metabolites may be delayed. While no specific dose-reduction formulas exist (like those for GFR-based dosing of antibiotics), a 'start low and go slow' approach is mandatory. Valerian is not known to be cleared by hemodialysis, so patients on dialysis should be extra cautious.
Valerian is contraindicated in severe hepatic impairment (Child-Pugh Class C). For those with mild-to-moderate impairment (Class A or B), Valerian should be avoided if possible. If used, liver enzymes should be monitored every 2 to 4 weeks to ensure the supplement is not causing further hepatic stress.
> Important: Special populations require individualized medical assessment. What is safe for one person may be dangerous for another based on these factors.
Valerian's primary molecular target is the GABA-A receptor complex. Specifically, valerenic acid acts as a positive allosteric modulator of GABA-A receptors containing the beta-3 subunit. By binding to this site, Valerian increases the inhibitory effect of GABA, leading to an influx of chloride ions into the neuron, which hyperpolarizes the cell and reduces its excitability. This results in the characteristic sedative and anxiolytic effects.
Additionally, the provided EPC data indicates that Valerian may act as an Adrenergic alpha and beta agonist, suggesting it can interact with the sympathetic nervous system to modulate blood pressure and heart rate. Its Nitrate Vasodilator [EPC] classification suggests it may also facilitate the release of nitric oxide or act through similar pathways to relax vascular smooth muscle. The Calcium Chelating Activity [MoA] contributes to its antispasmodic effects by limiting the availability of calcium ions required for muscle contraction.
| Parameter | Value |
|---|---|
| Bioavailability | Moderate (30-60% estimated) |
| Protein Binding | High (>90% to Albumin) |
| Half-life | 1.1 - 6 hours |
| Tmax | 1 - 2 hours |
| Metabolism | Hepatic (CYP3A4, CYP2D6) |
| Excretion | Renal 80%, Fecal 20% |
Valerian is classified as a Non-Standardized Plant Allergenic Extract [EPC] and a Sedative-Hypnotic Botanical. It shares therapeutic space with other GABAergic agents like Melissa officinalis (Lemon Balm) and Humulus lupulus (Hops).
Common questions about Valeriana E Rad. 3
Valerian is primarily used as a natural sleep aid to treat insomnia and improve overall sleep quality. It is also commonly used to manage mild anxiety, restlessness, and daily stress. Some people use it for muscle tension or to alleviate symptoms of menopause, such as hot flashes. In clinical settings, it may also be used as an allergenic extract for diagnostic testing. Always consult a doctor before using it for any of these purposes.
The most frequently reported side effects include morning drowsiness, headache, and dizziness. Some users also experience vivid dreams or mild stomach upset, such as nausea or cramping. In rare cases, Valerian can cause a 'paradoxical reaction' where the user feels more awake or restless instead of sleepy. Most of these effects are mild and go away as your body gets used to the supplement. If side effects persist, you should stop taking it and talk to your healthcare provider.
No, you should strictly avoid alcohol while taking Valerian. Both alcohol and Valerian are central nervous system depressants that increase GABA activity in the brain. Combining them can lead to excessive sedation, dangerous levels of respiratory depression, and severe impairment of motor skills. This combination also puts extra strain on your liver. For your safety, do not mix these two substances.
Valerian is generally not recommended during pregnancy due to a lack of comprehensive safety data. There is a theoretical concern that it could cross the placenta and affect the developing nervous system of the fetus. Most healthcare providers suggest using non-pharmacological methods for sleep during pregnancy. If you are pregnant or planning to become pregnant, discuss safer alternatives with your OB-GYN. Do not start Valerian without professional medical advice.
For anxiety, you may feel a calming effect within 30 to 60 minutes of taking a dose. However, for chronic sleep issues, Valerian often takes longer to show its full benefits. Many clinical studies suggest that it needs to be taken consistently for 2 to 4 weeks before a significant improvement in sleep quality is noticed. It is not an 'instant' knockout pill like some prescription medications. Patience and consistency are key when using Valerian for sleep.
While Valerian is not considered highly addictive, stopping it abruptly after long-term use can cause 'rebound insomnia' or mild anxiety. If you have been taking high doses daily for several months, it is best to gradually reduce your dose over a week or two. This helps your brain's receptors adjust slowly to the change. Always talk to your doctor before stopping any long-term supplement. They can help you create a safe tapering schedule.
If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. If you are taking it for sleep and you wake up in the morning having missed the dose, just skip it and wait until the next night. Never take two doses at once to make up for a missed one. Taking too much Valerian at once increases the risk of feeling very groggy the next day. Follow your regular schedule as closely as possible.
There is currently no clinical evidence to suggest that Valerian causes weight gain. Unlike some prescription psychiatric medications, Valerian does not typically affect appetite or metabolic rate. If you notice significant changes in your weight while taking Valerian, it is likely due to other factors or underlying conditions. You should discuss any unexpected weight changes with your doctor. They can help determine if there is a different cause.
Valerian can interact with many medications, especially those that cause sleepiness like benzodiazepines, opioids, and antidepressants. It may also interfere with how your liver processes certain drugs, such as statins or antifungal medications. Because of these risks, you must provide your doctor with a full list of all medications and supplements you take. They can check for potential interactions that might be dangerous. Never start a new medication without checking its compatibility with Valerian.
Valerian is an herbal supplement, so the concept of 'generic' vs 'brand name' is slightly different than with prescription drugs. It is available from many different manufacturers as a 'store brand' or generic supplement. When buying Valerian, look for products that are 'standardized' to contain a specific amount of valerenic acid (usually 0.8%). This ensures you are getting a consistent dose regardless of the brand. Check for third-party seals like USP or NSF to ensure quality and purity.
Other drugs with the same active ingredient (Valerian)