Valerian Root

Commercial formulations of 29 commonly used herbal supplements (HSs) and grapefruit juice were evaluated for drug interaction potential via quantification of their CYP3A inhibitory potential in two in vitro experimental models of human small intestine, cryopreserved human intestinal mucosa (CHIM), and cryopreserved human enterocytes (CHEs). Two CYP3A substrates were used-in the studies with CHIM, CYP3A activity was quantified via liquid chromatography tandem mass spectrometry quantification of midazolam 1'-hydroxylation, whereas in CHE, luciferin-IPA metabolism to luciferin was quantified by luminescence. Upon treatment of CHIM with the estimated lumen concentration of the HS upon each oral administration (manufacturers' recommended dosage dissolved in 200 ml of culture medium), >80% CYP3A inhibition was observed for green tea extract, St. John's wort, valerian root, horehound, and grapefruit juice. Less than 50% inhibition was observed for fenugreek, aloe vera, guarana, soy isoflavone, maca, echinacea, spirulina, evening primrose, milk thistle, cranberry, red yeast rice, rhodiola, ginkgo biloba, turmeric, curcumin, white kidney bean, garlic, cinnamon, saw palmetto berries, panax ginseng, black elderberry, wheat grass juice, flaxseed oil, black cohosh, and ginger root. The results were confirmed in a a dose-response study with HSs obtained from three suppliers for the four inhibitory HSs (green tea extract, horehound, St. John's wort, valerian root) and three representative noninhibitory HSs (black cohosh, black elderberry, echinacea). Similar results were obtained with the inhibitory HSs in CHE. The results illustrate that CHIM and CHE represent physiologically relevant in vitro experimental models for the evaluation of drug interaction potential of herbal supplements. Based on the results, green tea extract, horehound, St. John's wort, and valerian root may cause drug interactions with orally administered drugs that are CYP3A substrates, as was observed for grapefruit juice. SIGNIFICANCE STATEMENT: In vitro evaluation of 29 popular herbal supplements in cryopreserved human intestinal mucosa identified green tea extract, horehound, St. John's wort, and valerian

The risk of interaction between dietary supplements, herbal drugs and synthetic drugs increases when patients are treated chronically, e.g. due to impairment of central nervous system (CNS)--depression, psychotic disorders, Parkinson's and Alzheimer's diseases. On the basis of scientific literature, there was shown that simultaneous intake of antidepressants, antipsychotic drugs and herbal drugs or dietary supplements containing: St. John's wort, valerian root, ginkgo biloba leaf, hops, and food ingredients: dietary fiber or folic acid, may lead to interactions. Dietary fiber supplementation should be applied carefully during treatment of Parkinson's disease and in case of Alzheimer disease treatment--supplements containing ginkgo biloba leaf can increase the risk of interaction. Knowledge of these interactions is essential in effective treatment of this illness. However this area of science should be verified constantly due to growing number of new products registered as a supplements--often with complex composition.

Background: Dietary supplements promoted for brain health and enhanced cognitive performance are widely available. Claims made for these products are directed not only to the elderly wishing to prevent or mitigate cognitive decline, but also young healthy populations looking to boost their cognitive performance. It is unclear whether these claims made on product bottles and through advertising match the science. Objectives: To explore the evidence on the efficacy and safety of single dietary supplement ingredients frequently marketed with claims of enhanced cognitive performance among healthy adults. Design: A systematic review. Results: Nine of 54 dietary supplement ingredients identified through a scoping review met the eligibility criteria with at least 3 published studies identified per ingredient, yielding 69 unique publications. Ingredients evaluated included Bacopa monnieri, choline, creatine, omega-3 fatty acids, Ginkgo biloba, ginseng, Rhodiola rosea, tyrosine, and valerian root, all in supplement form and compared with a placebo, at various serving sizes and durations of use. Conclusions: The low level of certainty in the state of the science, coupled with not always knowing what is in a dietary supplement product, make weighing risks and benefits difficult; these data hinder the ability to develop recommendations about using such ingredients for consumers interested in boosting their cognitive performance. Whereas certain trends regarding promising serving sizes or duration for use, are pointed to in this synthesis, when combined, studies are inconsistent and imprecise, and many are methodologically flawed. Potential solutions to address research gaps are offered, for future research next steps, which is needed to strengthen the evidence and inform decisions.

Sleep problems are widely prevalent and associated with various comorbidities including anxiety. Valerian (Valeriana officinalis L.) is a popular herbal medicine used as a sleep aid, however the outcomes of previous clinical studies are inconsistent. This study was conducted to update and re-evaluate the available data in order to understand the reason behind the inconsistent outcomes and to provide a broader view of the use of valerian for associated disorders. PubMed, ScienceDirect, and Cochrane Library were searched to retrieve publications relevant to the effectiveness of valerian as a treatment of sleep problems and associated disorders. A total of 60 studies (n=6,894) were included in this review, and meta-analyses were performed to evaluate the effectiveness to improve subjective sleep quality (10 studies, n=1,065) and to reduce anxiety (8 studies, n=535). Results suggested that inconsistent outcomes were possibly due to the variable quality of herbal extracts and that more reliable effects could be expected from the whole root/rhizome. In addition, therapeutic benefits could be optimized when it was combined with appropriate herbal partners. There were no severe adverse events associated with valerian intake in subjects aged between 7 and 80 years. In conclusion, valerian could be a safe and effective herb to promote sleep and prevent associated disorders. However, due to the presence of multiple active constituents and relatively unstable nature of some of the active constituents, it may be necessary to revise the quality control processes, including standardization methods and shelf life.

Valerian root is the most commonly used herbal supplement for sedation and anxiolysis, but it is unknown whether it may affect functional brain connectivity. Our goal was to use electroencephalography (EEG) to investigate whether valerian root extract (VRE) affects resting-state connectivity changes and whether such changes are associated with clinical symptoms. This 4-week, double-blinded, randomized, placebo-controlled clinical trial was conducted with 64 nonclinical volunteers suffering psychological stress. The participants received VRE (100 mg) or a placebo thrice daily. We examined VRE's therapeutic effects on anxiety and stress-related psychological constructs. Functional brain connectivity changes were measured as EEG coherence in the alpha and theta frequency bands. The VRE and placebo groups both exhibited significant postintervention improvements on all clinical scales, but no significant between-group differences in these changes were noted. Compared with the placebo group, the VRE group exhibited significantly greater increases in frontal brain region alpha coherence across four electrode pairs, and these changes were significantly correlated with anxiolysis. The VRE group also exhibited significantly greater decreases in theta coherence across another four electrodes pairs. Our findings indicate that VRE alters functional brain connectivity in relation to anxiety. Further EEG studies are needed to confirm VRE's neurophysiological effects. © 2019 John Wiley & Sons, Ltd.

Valerian is a botanical used for its sedative effects whose central nervous system activity is ascribed to multiple constituents. Twenty-three established outpatient symptomatic Hispanic volunteers receiving mental health services at a large urban hospital participated in this case study. All complained of insufficient sleep. They were asked to try a popular national brand of valerian ("Nature's Way", 470 mg valerian root) and completed sleep questionnaires at baseline and at the end of Weeks 1 and 2. They were instructed to take 1 capsule each night before retiring and were allowed to increase their dose to a maximum of 3 capsules after Week 1. Twenty patients completed the trial. On an ordinal scale of 1 (no effect), 3 (moderately helpful), and 5 (extremely helpful), 16 patients rated their insomnia as at least "moderately improved" at the end of Week 1. By Week 2, 16 still rated themselves at least "moderately improved," but 15 of them now described their response as either a 4 or a 5. Global improvement at Week 2 was significantly better than at Week 1 (Wilcoxon ranks test p = .005), perhaps reflecting a time-dependent or dose-response relationship. This case study suggests that valerian can be a supplement for improving insomnia in a symptomatic population.

Low mental energy can contribute to decreased productivity, altered life balance, decreased physical performance, and ultimately affect quality of life. As such, there is a great demand for food and beverage products that positively impact mental energy. Numerous products claim to alter mental energy making continued review of the scientific evidence critical. The objective of this study was to conduct a scoping review of randomized controlled trials to evaluate the effect of 18 dietary ingredients on mental energy outcomes in adults without severe disease. Methods: A literature search, completed using PubMed, resulted in the identification of 2261 articles, 190 of which met eligibility from initial abstract review. Full-text review was completed on the 190 studies which resulted in 101 articles that fully met eligibility for inclusion in this study. The search strategy for two ingredients did not yield any eligible studies, leaving studies for 16 ingredients that were extracted and summarized by reported significantly improved outcomes for cognition, mood and perceived feelings, and sleep assessments. The preliminary results for several dietary ingredients directionally suggested a mental energy benefit (≥20% of outcomes), including ashwagandha, chamomile, dark chocolate, ginseng, green tea, lavender, lion's mane mushroom, maca, tart cherries, turmeric, and valerian root. The results of this scoping review suggest that of the 16 dietary ingredients reviewed, 11 may be promising for further exploration on their potential benefits in supporting mental energy. Given consumer demand and market growth for food and beverage products that positively impact mental energy; continued efforts in assessment method alignment and additional evaluation in well-designed trials is warranted.KEY TEACHING POINTSOf the 16 dietary ingredients reviewed, 11 (ashwagandha, chamomile, dark chocolate, ginseng, green tea, lavender, lion's mane mushroom, maca, melatonin foods, turmeric, and valerian root) may be promising for further exploration on their potential mental energy benefits.Dark chocolate, ginseng, ashwagandha, and lion's mane mushroom were the most promising ingredients for f

OBJECTIVE: To assess the effect of valerian root extract on the sleep quality of patients after coronary artery bypass graft (CABG) surgery. METHODS: The patients who participated in this triple-blind clinical trial were selected by permuted block randomization. The participants were assigned to the valerian (n=36) and placebo (n=36) groups. The valerian group received 530 mg of valerian capsules for 30 nights after CABG surgery, and the placebo group received 530 mg of the placebo capsules containing wheat flour. The Pittsburgh Sleep Quality Index (PSQI), the prothrombin time (PT) and partial thromboplastin time (PTT) were assessed on four occasions, including the baseline, the 3rd, 14th and 30th days following intervention. RESULTS: The odds ratio of worsened sleep quality significantly varied over time (the interaction of time and group) in the valerian group compared to the placebo group in various dimensions including total sleep quality (P=0.001), sleep latency (P<0.01), sleep duration (P=0.020), sleep efficiency (P=0.001) and daytime dysfunction (P=0.025). No significant difference was observed in the alterations of the odds ratio of PT in the two groups over time. (P=0.371). CONCLUSION: The consumption of oral valerian root extract over 30 nights could significantly improve the patients' sleep quality safely after CABG surgery.

RATIONALE: We hypothesized that valerian root might prevent cognitive dysfunction in coronary artery bypass graft (CABG) surgery patients through stimulating serotonin receptors and anti-inflammatory activity. OBJECTIVES: The aim of this study was to evaluate the effect of Valeriana officinalis root extract on prevention of early postoperative cognitive dysfunction after on-pump CABG surgery. METHODS: In a randomized, double-blind, placebo-controlled trial, 61 patients, aged between 30 and 70 years, scheduled for elective CABG surgery using cardiopulmonary bypass (CPB), were recruited into the study. Patients were randomly divided into two groups who received either one valerian capsule containing 530 mg of valerian root extract (1,060 mg/daily) or placebo capsule each 12 h for 8 weeks, respectively. For all patients, cognitive brain function was evaluated before the surgery and at 10-day and 2-month follow-up by Mini Mental State Examination (MMSE) test. RESULTS: Mean MMSE score decreased from 27.03 ± 2.02 in the preoperative period to 26.52 ± 1.82 at the 10th day and then increased to 27.45 ± 1.36 at the 60th day in the valerian group. Conversely, its variation was reduced significantly after 60 days in the placebo group, 27.37 ± 1.87 at the baseline to 24 ± 1.91 at the 10th day, and consequently slightly increased to 24.83 ± 1.66 at the 60th day. Valerian prophylaxis reduced odds of cognitive dysfunction compared to placebo group (OR = 0.108, 95 % CI 0.022-0.545). CONCLUSION: We concluded that, based on this study, the cognitive state of patients in the valerian group was better than that in the placebo group after CABG; therefore, it seems that the use of V. officinalis root extract may prevent early postoperative cognitive dysfunction after on-pump CABG surgery.

OBJECTIVE: Obsessive-Compulsive Disorder (OCD) is a common neuropsychiatric condition. Many herbs with psychotropic effects exist which can have fewer side effects compared to more conventional medications. Valeriana Officinalis L. is a well-known medicinal plant with a long history of usage in the world with an effect on GABA. This plant is reported to be safe on humans. Our objective in this study was to compare the efficacy of the extract of Valeriana Officinalis L. with placebo in the treatment of OCD. METHODS: The study was an 8-week pilot double-blind randomized trial. Thirty-one adult outpatients who met the DSM-IV-TR criteria for OCD based on the structured clinical interview participated in the trial. In this double-blind and randomized trial, patients were randomly assigned to receive either capsule of the extract (765 mg/day) or placebo (30 mg/day) for 8 weeks. RESULTS: The results showed significant difference between the extract and placebo in the end of treatment (P=0.000). Somnolence was the only significant difference between the two groups in terms of observed side effects (P=0.02). CONCLUSION: The results suggest that Valeriana Officinalis L. has some antiobsessive and compulsive effects. However, further studies are needed to confirm these findings. Psychiatrists often find that many patients cannot tolerate the side effects of psychiatry medicine Valeriana Officinalis L. is a well-known medicinal plant with a long history of usage in world with effect on GABA.The results showed significant difference between the extract and placebo in the treatment of OCD. There was also no significant difference between the two groups in terms of observed side effects.

Herbal drugs are often used in patients with somatoform disorders yet, the available evidence is limited. The aim of the present short-term study was to evaluate in a pharmaco-clinical trial the additional benefit of butterbur in a fixed herbal drug combination (Ze 185 = 4-combination versus 3-combination without butterbur and placebo) in patients with somatoform disorders.For a 2-week treatment in patients with somatization disorder (F45.0) and undifferentiated somatoform disorder (F45.1), 182 patients were randomized for a 3-arm trial (butterbur root, valerian root, passionflower herb, lemon balm leaf versus valerian root, passionflower herb, lemon balm leaf versus placebo). Anxiety (visual analogue scale - VAS) and depression (Beck's Depression Inventory - BDI) served as primary parameters, Clinical Global Impression (CGI) was a secondary parameter.The 4-combination was significantly superior to the 3-combination and placebo (4-combination > 3-combination > placebo) in all the primary and secondary parameters (PP-population). Analysis of the ITT population confirmed these results. As to safety, no serious adverse events occurred. In total 9 non-serious adverse events were documented but the distribution did not differ significantly between the treatment groups.This herbal preparation (Ze185) showed to be an efficacious and safe short-term treatment in patients with somatoform disorders.

A randomised, controlled, double-blind trial was performed on 102 male and female volunteers to determine whether reaction time, alertness and concentration might be impaired by treatment with a native valerian root extract (VRE). The effect was first examined the morning after a single evening dose of VRE (600 mg LI 156) vs. flunitrazepam (FNZ) (1 mg) and placebo (PL) (trial section A), and then after two weeks of evening administration of VRE (600 mg LI 156) vs. PL (trial section B). 99 volunteers were analysed in section A and 91 in section B. The primary criterion was the median of reaction time (MRT) measured with the Vienna Determination Test. Secondary criteria were cognitrones (alertness test), tracking test (two-handed co-ordination), sleep quality (VIS-A, Vis-M), further VDT parameters, and safety criteria. The single administration of LI 156 did not impair the reaction abilities, concentration and co-ordination. After 14 days of treatment, the equivalence of VRE and PL was proven by confirmative analysis concerning the improvement of MRT (p = 0.4481). Evaluation of the secondary criteria were consistent with the results of the primary criterion. It is concluded that neither single nor repeated evening administrations of 600 mg of VRE have a relevant negative impact on reaction time, alertness and concentration the morning after intake.

9. Psychopharmacology (Berl). 1985;87(4):406-9. doi: 10.1007/BF00432503. Effect of valerian on human sleep. Balderer G, Borbély AA. The effect of an aqueous extract of valerian root on sleep was studied in two groups of healthy, young subjects. One group (N = 10) slept at home, the other (N = 8) in the sleep laboratory. Sleep was evaluated on the basis of questionnaires, self-rating scales and night-time motor activity. In addition, polygraphic sleep recordings and spectral analysis of the sleep EEG was performed in the laboratory group. Under home conditions, both doses of valerian extract (450 and 900 mg) reduced perceived sleep latency and wake time after sleep onset. Night-time motor activity was enhanced in the middle third of the night and reduced in the last third. The data suggest a dose-dependent effect. In the sleep laboratory, where only the higher dose of valerian was tested, no significant differences from placebo were obtained. However, the direction of the changes in the subjective and objective measures of sleep latency and wake time after sleep onset, as well as in night-time motor activity, corresponded to that observed under home conditions. There was no evidence for a change in sleep stages and EEG spectra. The results indicate that the aqueous valerian extract exerts a mild hypnotic action.

10. Pharmacol Biochem Behav. 1982 Jul;17(1):65-71. doi: 10.1016/0091-3057(82)90264-7. Aqueous extract of valerian root (Valeriana officinalis L.) improves sleep quality in man. Leathwood PD, Chauffard F, Heck E, Munoz-Box R. The effect of an aqueous extract of valerian (Valeriana officinalis L.) root on subjectively rated sleep measures was studied on 128 people. Each person received 9 samples to test (3 containing placebo, 3 containing 400 mg valerian extract and 3 containing a proprietary over-the-counter valerian preparation). The samples, identified only by a code number, and presented in random order, were taken on non-consecutive nights. Valerian produced a significant decrease in subjectively evaluated sleep latency scores and a significant improvement in sleep quality: the latter was most notable among people who considered themselves poor or irregular sleepers, smokers, and people who thought they normally had long sleep latencies. Night awakenings, dream recall and somnolence the next morning were relatively unaffected by valerian. With the proprietary valerian-containing preparation, the only change was a significant increase in reports of feeling more sleepy than normal the next morning. Thus the questionnaire, simple to use and non-invasive, provides a sensitive means for detecting the effects of mild sedatives on different aspects of sleep in man. It also allows identification within the test population of the subgroups most affected.

BACKGROUND Sexsomnia, a subtype of non-REM (NREM) parasomnia, consists of atypical sexual behaviors during sleep and presents with diagnostic and therapeutic challenges due to its under-recognition and overlap with other sleep and psychiatric disorders. Thus, its early diagnosis is quite challenging and important. CASE REPORT A 29-year-old man presented with a 2-year history of abnormal nocturnal sexual behaviors including pelvic thrusting, masturbation, and attempted intercourse during sleep reported by his partner, consistent with sexsomnia. All episodes occurred with complete amnesia. The symptoms intensified during periods of anxiety, occupational stress, and long work hours. The behaviors caused distress for his partner, resulting in a strain on their relationship. The patient reported a history of childhood sleep terrors and a family history of parasomnia. He exhibited no significant medical comorbidities or signs of obstructive sleep apnea, as supported by low STOP-BANG and Epworth Sleepiness Scale scores. Polysomnography and neurological imaging results were unremarkable. Initial therapy with fluoxetine (20 mg/day), melatonin (3 mg nightly), and clomipramine (25 mg nightly) was unsuccessful, but self-administered valerian root supplementation achieved a 90% reduction in symptoms due to its GABAergic effects. Subsequent treatment with vortioxetine (20 mg daily) led to complete remission, continued during a 3-month follow-up period. CONCLUSIONS This report emphasizes the importance of individualized approaches in diagnosing and managing sexsomnia. The patient's positive response to valerian root highlights the potential role of natural supplements in managing selected cases. It further highlights the need for increased clinical awareness and future research into natural and behavioral inter

BACKGROUND: Autism spectrum disorder (ASD), marked by social communication deficits and repetitive behaviors, significantly impacts the quality of life for kids and caregivers. Herbal medicines help manage symptoms, yet no comprehensive review has collectively summarized recent evidence (2018-mid-2025). METHODS: This narrative review utilized searches across PubMed, Scopus, Web of Science, and Google Scholar to identify studies published on herbal medicines for ASD. Inclusion criteria prioritized clinical trials and preclinical studies detailing plant bioactive compounds, dosing, and mechanisms. KEY FINDINGS: Prominent herbs include Bacopa monnieri, which can enhance cognitive flexibility via bacosi

Valerian root extracts are widely used as mild sedatives to promote sleep, with clinical studies confirming their efficacy. Their sleep-promoting effects are associated with the adenosine A1 receptor (A1AR), a key regulator of sleep through neural activity inhibition. Adenosine, a neuromodulator that accumulates during wakefulness, activates A1ARs to facilitate sleep transitions. Using advanced analytics, we detected adenosine at 0.05% in the valerian extract Ze 911, supporting direct A1AR activation in vitro. Additionally, we explored A1ARs' allosteric sites for modulatory activity. Valerenic acid and pinoresinol, key constituents of Ze 911, were identified as positive allosteric modulators (PAMs) of A1ARs. Valerenic acid exhibited strong PAM activity, with high cooperativity (αβ = 4.79 for adenosine and αβ = 23.38 for CPA) and intrinsic efficacy (τB = 5.98 for adenosine and τB = 3.14 for CPA). Pinoresinol displayed weaker PAM activity, with moderate cooperativity (αβ = 3.42 for adenosine and αβ = 0.79 for CPA) and limited efficacy (τB = 0.93 for adenosine and τB = 1.66 for CPA). The allosteric modulation observed in valerian extract Ze 911 suggests a mechanism of action in which valerenic acid and pinoresinol enhance receptor activation through allosteric interactions, potentially amplifying the effects of endogenous adenosine. By targeting A1ARs' allosteric sites, valerian extract Ze 911 offers increased therapeutic selectivity and reduced off-target effects, emphasizing its potential for managing sleep disorders.

Humans spend approximately one third of their life asleep but, as counterintuitive as it may sound, sleep is far from being a quiet state of inactivity. Sleep provides the opportunity to perform numerous biological and physiological functions that are essential to health and wellbeing, including memory consolidation, physical recovery, immunoregulation, and emotional processing. Yet, sleep deprivation, chronic sleep restriction, and various types of sleep disorders are all too common in modern society. Failure to meet the recommended 7-9 hours of restful sleep per night is known to increase the risk of several health conditions, reason why regular and adequate sleep should be seen as a priority instead of an unnecessary commodity easily traded as required by the commitments of our busy lives. While both the quantity and the quality of sleep can be largely improved with relatively straightforward practices dictated by good sleep hygiene, emerging research suggests that dietary and supplementation protocols focused on certain foods, nutrients, and biochemical compounds with sleep-promoting properties can act as subsidiary sleep aids in complementing these behavioral changes. The scope of this narrative review is to summarize the available evidence on the potential benefits of selected nutraceuticals in the context of circadian rhythm and sleep disturbances, namely melatonin, magnesium, omega-3 fatty acids, tart cherry juice, kiwifruit, apigenin, valerian root, L-theanine, glycine, ashwagandha, myoinositol, Rhodiola rosea, and phosphatidylserine. A comprehensive recapitulation of the relevant literature is provided, alongside corresponding evidence-based nutritional protocols to promote and improve restful sleep. © The Author(s) 2025. Published by Oxford University Press on behalf of the International Life Sciences Institute.

Background: Healthy aging is defined as survival to advanced age while retaining autonomy in activities of daily living, high societal participation, and good quality of life. Sarcopenia, insomnia, cognitive impairment, and changes in sensation can be key hinderances to healthy aging, but nutritional supplements may abate their impact. As research advances, an updated review on their efficacy on age-related conditions is warranted. Results: Sarcopenia can be mitigated through proper protein intake, supplements like creatine, and in certain situations Branched-Chain Amino Acids and Vitamin D, in adults over 65. Melatonin supplementation has moderate evidence for improving sleep, while valerian root lacks evidence. Magnesium, tart cherry, and kiwifruits have shown promising impacts on sleep in limited articles. Magnesium, Vitamin D, and B vitamin supplementation have been shown to improve cognition in those with mild cognitive impairment and Alzheimer's disease but require further study prior to recommendation. The Age-Related Eye Disease Study supplement combination is routinely recommended to reduce risk of progression to advance stages of age-related macular degeneration. Alpha-Lipoic Acid and Folate have been investigated for their roles in mitigating age-related hearing losses. Conclusi

Sleep is a restorative period that plays a crucial role in the physiological functioning of the body, including that of the immune system, memory processing, and cognition. Sleep disturbances can be caused by various physical, mental, and social problems. Recently, there has been growing interest in sleep. Maydis stigma (MS, corn silk) is a female maize flower that is traditionally used as a medicinal plant to treat many diseases, including hypertension, edema, and diabetes. It is also used as a functional food in tea and other supplements. β-Sitosterol (BS) is a phytosterol and a natural micronutrient in higher plants, and it has a similar structure to cholesterol. It is a major component of MS and has anti-inflammatory, antidepressive, and sedative effects. However, the potential effects of MS on sleep regulation remain unclear. Here, we investigated the effects of MS on sleep in mice. The effects of MS on sleep induction were determined using pentobarbital-induced sleep and caffeine-induced sleep disruption mouse models. MS extracts decreased sleep latency and increased sleep duration in both the pentobarbital-induced sleep induction and caffeine-induced sleep disruption models compared to the positive control, valerian root extract. The butanol fraction of MS extracts decreased sleep latency time and increased sleep duration. In addition, β-sit

OBJECTIVES: Traditional treatment methods are becoming popular and commonly used in many societies and have become the first treatment option for most people. While some of these methods are helpful, they can interact with medications the patient is taking for another disease and cause a variety of life-threatening risks. Valerian (catweed) plant is used in traditional medicine as a sleep aid due to its sedative effects. Valerian may also exert anticancer effect in vitro. MATERIALS AND METHODS: In this study, the cytotoxicty and oxidative stress effects of valerian root extract were evaluated in human liver hepatocellular carcinoma (Hepg2) and human colorectal adenocarcinoma (Caco2) cell lines. The cytotoxicity was evaluated via the 3-(4,5-dimethythiazol-2-yl)-2,5-diphenyl tetrazolium bromide test. Total reactive oxygen species analysis was performed via a 2',7'-dichlorodihydrofluorescein diacetate assay in flow cytometry. RESULTS: Inhibition concentration 50 values were calculated as 936.6 and 1097.5 µg/mL in the Hepg2 and Caco2 cell lines, respectively. It was observed that valerian root extract did not induce oxidative stress in HepG2 and Caco2 cell lines. CONCLUSION: These results indicate that the use of valerian root extract as an alternative method in cancer treatment may not be effective and may cause a risk for public health. On the other hand, it may be safe at recommended tolerated concentrations since it does not cause oxidative stress. Conflict of interes

The toxicological risk assessment (TRA) of elemental impurities (EI) in especially herbal medicinal products (HMP) is a significant challenge for pharmaceutical industry. In Europe, very popular are traditional HMP with valerian root (Valeriana officinalis L., radix) for relief of mild symptoms of mental stress and to aid sleep. The aim of our unique article is the comprehensive TRA of Cu, Mn, and Zn as EI in HMP with V. officinalis L., radix available in Polish pharmacies. This article is a continuation of our previously conducted studies about TRA of heavy metals (Pb and Cd) in these same samples. Investigated elements were determined by flame atomic absorption spectrometry (F AAS). The values of the correlation coefficients (R > 0.998) confirm the linearity of the applied instrument for precision and accuracy of results. The recoveries, LOD and LOQ values were acceptable. Our results show that all investigated HMP with valerian root available in Polish pharmacies contain Cu (0.16-0.23 mg/L), Mn (0.11-0.76 mg/L), and Zn (0.22-0.48 mg/L) at a very low level. Based on our estimation of EI including single dose (µg/20 mL) and estimated daily intake (µg/day), our results confirm the safety of all pharmaceuticals. To the best of our knowledge, the Cu, Mn, and Zn impurity profile in HMP with V. officinalis L., radix is described for the first time. The applied methodology and results are extremel

9. Valerian. Drugs and Lactation Database (LactMed®) [Internet]. Bethesda (MD): National Institute of Child Health and Human Development; 2006–. 2021 May 17. Valerian (Valeriana officinalis) root contains mono- and sesquiterpenes, and iridoid triesters (valepotriates). Preparations are sometimes standardized on valerenic acid content. Valerian has no specific uses in nursing mothers, but is most commonly used to treat anxiety and sleep disturbances, and occasionally for self-treatment of postpartum blues or depression.[1,2] No data exist on the safety and efficacy of valerian in nursing mothers or infants. In general, valerian is well tolerated, with side effects such as dizziness, hangover or headache reported occasionally. Valerian is "generally recognized as safe" (GRAS) for use in food by the U.S. Food and Drug Administration. Valerian is often not recommended during lactation because of the theoretical concerns over its valepotriates and baldrinals which have been shown to be cytotoxic and mutagenic in vitro. Because there is no published experience with valerian during breastfeeding, an alternate therapy may be preferred, especially while nursing a newborn or preterm infant. Dietary supplements do not require extensive pre-marketing approval from the U.S. Food and Drug Administration. Manufacturers are responsible to ensure the safety, but do not need to prove the safety and effectiveness of dietary supplements before they are marketed. Dietary supplements may contain multiple ingredients, and differences are often found between labeled and actual ingredients or their amounts. A manufacturer may contract with an independent organization to verify the quality of a product or its ingredients, but that does not certify the safety or effectiveness of a product. Because of the above issues, clinical testing results on one product may not be applicable to other products. More detailed information about dietary supplements is available elsewhere on the LactMed Web site.

Elemental impurities (EIs) profiling in final pharmaceutical products is often not adequately treated, however it is crucial problem in pharmaceutical analysis by reason of the various regulatory authorities (like ICH Q3D guideline). EIs in pharmaceuticals may arise from numerous sources of which the herbal ingredients are not a frequent subject of pharmaceutical analyses. However, based on number of traditional use registrations per year for herbal medicinal products (HMPs) in the EU, it can be stated that monocomponent HMPs are still very popular for use. Due to the high frequency of use, exposure to EIs from HMPs may be high during long-term use. The aim of our article was Ni and Cr impurities profiling of Valeriana officinalis L., radix (Valerian root) as an example of the HMP available in Polish pharmacies for the relief of mild nervous tension and sleep disorders. The choice of metals was justified by: (1) a single dose of Ni administered via oral route can induce dermatitis in nickel-sensitised individuals; (2) Cr is a very problematic element from toxicological point of view. Our results indicate that the standards of the ICH Q3D guideline are met for all EIs.

Studies related to the toxicological risk assessment (TRA) of heavy metal impurities (HMIs) in pharmaceuticals are an important issue but there is a lack of refereed literature around the safety of Valeriana officinalis L., radix (Valerian root) as herbal medicinal product (HMP) for the relief of mild nervous tension and sleep disorders according to lead and cadmium impurities. The aim of the study was to estimate the TRA of lead and cadmium in Valeriana officinalis L., radix (Valerian root) as HMP (n = 5) available in Polish pharmacies. In the case of herbal pharmaceuticals, it is particularly important to control the level of HMIs accumulated during the plant's growth. Perhaps, the exposure for a single dose is not relevant; however, justification of our studies is a fact that herbal therapies are usually long term. Therefore, even small HMI doses as present in particular plant may accumulate in patient body over a long period of time. Levels of lead and cadmium were measured by electrothermal atomization atomic absorption spectrometry. The levels of lead and cadmium as HMIs (independently of the producer and declared composition) are quite similar. Our results are satisfactory, confirming the safety of Valeriana officinalis L., radix (Valerian root) as herbal medicinal product for the relief of mild nervous tension and sleep disorders available in Polish pharmacies acc

Valerian root (Valeriana officinalis) is a popular and widely available herbal supplement used to treat sleeping disorders and insomnia. The herb's ability to ameliorate sleep dysfunction may signify an unexplored anti-tumorigenic effect due to the connection between circadian factors and tumorigenesis. Of particular interest are the structural similarities shared between valeric acid, valerian's active chemical ingredient, and certain histone deacteylase (HDAC) inhibitors, which imply that valerian may play a role in epigenetic gene regulation. In this study, we tested the hypothesis that the circadian-related herb valerian can inhibit breast cancer cell growth and explored epigenetic changes associated with valeric acid treatment. Our results showed that aqueous valerian extract reduced growth of breast cancer cells. In addition, treatment of valeric acid was associated with decreased breast cancer cell proliferation, migration, colony formation and 3D formation in vitro in a dose- and time-dependent manner, as well as reduced HDAC activity and a global DNA hypomethylation. Overall, these findings demonstrate that valeric acid can decrease the breast cancer cell proliferation possibly by mediating epigenetic modifications such as the inhibition of histone deacetylases and alterations of DNA methylation. This study highlights a potential utility of valeric acid as a novel HDAC inhibitor and a therapeutic agent in the treatment of breast cancer. DOI

Alzheimer's disease (AD) impacts millions of individuals worldwide. Since no cure is currently available, acetylcholinesterase inhibitors are symptomatic therapy. This study assessed community pharmacists' knowledge regarding donepezil adverse effects (AEs) and self-care recommendations for insomnia management for persons with AD treated with rivastigmine. This is a cross-sectional, standardized telephone survey of community pharmacists (n = 862) in three study areas: West Virginia, North Dakota/South Dakota, and Southern Oregon/Northern California. Pharmacists' degree, sex, and pharmacists' AD-related knowledge were assessed. In-stock availability of donepezil and rivastigmine formulations was assessed. Analyses were performed using Stata 10.1. Only 31.4% pharmacists were able to name ≥2 donepezil AEs. Only four donepezil AEs were named by at least 13% of pharmacists: nausea (36.1%), dizziness (25.1%), diarrhea (15.0%), and vomiting (13.9%). All other AEs were named by fewer than 7% of respondents. Only 62.9% of pharmacists (n = 542) provided appropriate recommendations: melatonin (40.3%), referral to physician (22.0%), or sleep hygiene (0.6%). Over 12% of pharmacists (n = 107) provided inappropriate recommendations (anticholinergic agent or valerian root) and 21.5% of pharmacists were unable to provide any recommendation. We identified significant gaps in community pharmacists' knowledge regarding donepezil AEs and non-prescription insomnia recommendation needing significant improvement to ensure high-quality AD-related care.

BACKGROUND: Valerian root and lemon balm extracts have previously shown efficacy and excellent tolerability in children<12 years suffering from restlessness and insomnia. We now examined whether treatment with a fixed combination of both may also improve concentration, hyperactivity and impulsiveness. METHODS: 169 primary school children suffering from hyperactivity and concentration difficulties but not meeting ADHS criteria were treated in an observational study by 27 office based pediatricians with a recommended daily dose of 640 mg valerian root extract WS(®) 1014 and 320 mg lemon balm extract WS(®) 1303 (Sandrin(®)), and evaluated by pediatricians and parents using standardized questionnaires at baseline, weeks 2 and 7. RESULTS: The fraction of children having strong/very strong symptoms of poor ability to focus decreased from 75% to 14%, hyperactivity from 61% to 13%, and impulsiveness from 59% to 22%. Parent rated social behavior, sleep and symptom burden showed highly significant improvements. Only in two children mild transient adverse drug reactions were observed. CONCLUSION: In primary school children with restlessness, concentration difficulties and impulsiveness treatment with WS(®) 1014 and WS(®) 1303 (Sandrin(®)) provides a viable option in addition to counseling and education.

Herbal extracts targeting at the brain remain a continuous challenge to pharmacology. Usually, a number of different animal tests have to be performed in order to find a potential clinical use. Due to manifold possibly active ingredients biochemical approaches are difficult. A more holistic approach using a neurophysiological technique has been developed earlier in order to characterise synthetic drugs. Stereotactic implantation of four semi-microelectrodes into frontal cortex, hippocampus, striatum and reticular formation of rats allowed continuous wireless monitoring of field potentials (EEG) before and after drug intake. After frequency analysis (Fast Fourier Transformation) electric power was calculated for 6 ranges (delta, theta, alpha1, alpha2, beta1 and beta2). Data from 14 synthetic drugs - tested earlier and representative for different clinical indications - were taken for construction of discriminant functions showing the projection of the frequency patterns in a six-dimensional graph. Quantitative analysis of the EEG frequency pattern from the depth of the brain succeeded in discrimination of drug effects according to their known clinical indication (Dimpfel and Schober, 2003). Extracts from Valerian root, Ginkgo leaves, Paullinia seed, Hop strobile, Rhodiola rosea root and Sideritis scardica herb were tested now under identical conditions. Classification of these extracts based on the matrix from synthetic drugs revealed that Valerian root and hop induced a pattern reminiscent of physiological sleep. Ginkgo and Paullinia appeared in close neighbourhood of stimulatory drugs like caffeine or to an analgesic profile (tramadol). Rhodiola and Sideritis developed similar frequency patterns comparable to a psychostimulant drug (methylphenidate) as well to an antidepressive dr

Emotional and behavioral problems in children and adolescents are no exception. To what extent a fixed plant extract combination is able to support children suffering from nervous agitation due to agitated depression among others for approximately 2 years has been investigated in a multicenter, prospective observational study (2008) with 115 children between 6 and 12 years. Assessments of the parents showed a distinct improvement in children who had attention problems, showed social withdrawal, and/or were anxious/depressive. Based on the physicians' assessment, 81.6-93.9% of the affected children had no or just mild symptoms at the end of observation concerning nine of thirteen evaluated symptoms such as depression, school/examination anxieties, further anxieties, sleeping problems, and different physical problems. Therapeutic success was not influenced by additional medication or therapies. The treatment was well tolerated. The used plant extracts have been gained from St. John's Wort herb, valerian root, and passionflower herb. Emotionale Probleme und Verhaltensauffälligkeiten bei Kindern und Jugendlichen sind keine Ausnahme. Inwieweit Kindern, die seit etwa 2 Jahren unter nervöser Unruhe (unter anderem aufgrund agitierter Depression) litten, durch eine Behandlung mit einem pflanzlichen Kombinationspräparat geholfen werden kann, zeigt eine multizentrische, prospektive Beobachtungsstudie (2008) mit 115 Kindern im Alter von 6 bis 12 Jahren. Nach Einschätzung der Eltern zeigte sich eine klare Besserung insbesondere bei Konzentrationsstörungen, sozialem Rückzug, bei Kindern, die unter Ängsten und/oder Depressionen litten. Basierend auf der Beurteilung der Ärzte waren 81,6–93,9 % der Kinder am Ende der Beobachtungszeit beschwerdefrei oder hatten nur noch leichte Beschwerden in Bezug auf neun der dreizehn untersuchten Symptome, wie Depr

BACKGROUND: Anxiety disorders and sleep problems are common in the general population and are a cause of frequent consultations in primary care. These problems have significant impact on quality of life and functionality of individuals. The extracts of valerian root have been widely used for a long time by the population and physicians, for their sedative effects, hypnotic and anxiolytic. It is therefore urgent to know what are the benefits and the risks of using this substance for the treatment of anxiety and sleep disorders. OBJECTIVE: To investigate the efficacy and safety of valerian for the treatment of anxiety and sleep disorders. METHODS: A research was carried out for clinical practice guidelines, systematic reviews (SR), meta-analysis (MA) and randomized controlled trials (RCT) in Pubmed, sites of evidence-based medicine and Índex das Revistas Médicas Portuguesas using the MeSH terms valerian, anxiety and sleep disorders, and respective DeCS, analyzing articles in English, Spanish, French or Portuguese, published between January 2000 and March 31, 2010. We also reviewed references of relevant articles. We used the Strength of Recommendation Taxonomy (SORT) from American Family Physician to evaluate the level of evidence and assigning the strength of a recommendation. RESULTS: We found 173 articles of which four were selected which met the inclusion criteria: a meta-analysis, a SR and a RCT concerning the use of valerian in sleep disorders, and an SR on the use of valerian in anxiety disorders. The evidence is insufficient regarding the efficacy of valerian in the treatment of anxiety disorders (SOR A). There seems to be some evidence of the effectiveness of valerian for treating insomnia, which is limited by the quality of existing studies (SOR B). Valerian root is well tolerated and safe, with infrequent and benign side effects (SOR A). DISCUSSIO

Valeriana officinalis L. is a popular herbal treatment for mild sleep disorders. Clinical and non-clinical studies found contradictory results for valerian extracts and single constituents regarding the influence on sleep parameters. It was the aim of this study to investigate the sedative effects of a valerian root extract. Therefore, locomotor activity and core body temperature were recorded in male mice using radiotelemetry. A 70 % ethanolic extract prepared from the roots of V. officinalis (s. l.) and some of its single constituents, valerenic acid, linarin, and apigenin, were tested for effects on locomotion and body temperature over 180 minutes after oral administration. The extract was tested in a dose range of 250-1000 mg/kg, and only a dose of 1000 mg/kg valerian extract showed a mild short-term sedative effect with reduced locomotor activity between 66-78 min minutes after administration. Paradoxically, an increased activity was observed after 150 minutes after gavage. A dose of 1 mg/kg valerenic acid produced an intermittent stimulation of activity. However, a mild short-term sedative effect was found for linarin at 12 mg/kg and apigenin at 1.5 mg/kg. Considering the cumulative locomotor activity over the observation period of 180 min, it is concluded that neither the extract nor one of the compounds had considerable sedative effects. More precisely, the observed short-term changes in activity pattern indicate that valerian extract as well as the flavonoids linarin and apigenin are rather effective to reduce sleep latency than to act as a sleep-maintaining agent. © Georg Thieme Verlag KG Stuttgart · New York.

19. Georgian Med News. 2006 May;(134):121-4. [Toxicological approach to evaluation of bioavailability of powdered medicinal herbs]. [Article in Russian] Gedevanishvili MD, Sikharulidze IS, Gogotidze NM. Neurotoxicity manifestations related to the extraction of active ingredients from "natural" powdered Atropa belladonna (NPB) and Leonurus cardiaca (NPL) in gastrointestinal tract and respectively of their bioavailability were studied in mice. The symptoms were compared with action of approved officinal extracts. In response to orally administered NPB suspension mice displayed well-defined symptoms of typical cholinolytic appearance. On p.o. administration NPB appeared approximately twice as active as officinal concentrated extract. Sequential administration of NPB and of neostigmine eliminated CNS toxicity confirming the bioavailability and notable cholinolytic activity of NPB. Behavioral, neurological and autonomic profiles developed in response to elevated p.o. doses of NPL were typical of sedative - hypnotic drugs, while maximum prolongation of barbiturate- induced sleep was achieved when "no-effect" doses of NPL and powdered valerian root suspensions were administered concurrently, demonstrating mutual potentiation of specific activity of these natural (non-processed) powders, and respectively excellent bioavailability of their active principles.

OBJECTIVES: To describe the pharmacokinetics of valerenic acid in a group of healthy adults after a single oral dose of valerian using a newly developed sensitive assay for serum concentrations of valerenic acid, a commonly used marker for qualitative and quantitative analysis of valerian root and valerian products. STUDY DESIGN: Six healthy adults (22-61 years, five men, one female) received a single 600 mg dose of valerian at 08:00. Blood samples were collected for 8 h after administration. Valerenic acid was extracted from serum and measured using a LC/MS/MS method developed in our laboratory. RESULTS: The maximum serum concentration of valerenic acid for five of the six subjects occurred between 1 and 2 h ranging from 0.9 to 2.3 ng/mL. Valerenic acid serum concentrations were measurable for at least 5 h after the valerian dose. One subject showed a peak plasma value at 1 h and a second peak at 5 h. The elimination half-life (T(1/2)) for valerenic acid was 1.1 +/- 0.6 h. The area under the concentration time curve (AUC) as a measure of valerenic acid exposure was variable (4.80 +/- 2.96 microg/mL. h) and not correlated with subject's age or weight. CONCLUSIONS: Assuming that valerenic acid serum concentrations correlate with the pharmacological activity of valerian, the timing of the valerenic acid peak concentration is consistent with the standard dosage recommendation to take valerian 30 min to 2 h before bedtime. Ongoing studies are evaluating the relationship between valerenic acid serum concentrations and objective measures of sleep in patients. Copyright 2005 John Wiley & Sons, Ltd.

21. Prescrire Int. 2005 Jun;14(77):104-7. Management of insomnia: a place for traditional herbal remedies. [No authors listed] (1) Insomnia should be treated first with non drug measures; this has traditionally involved the use of herbal remedies. (2) About 20 plants are approved in France in the production of medications 'traditionally used' for minor sleep disturbances. Virtually nothing is known of their efficacy or potential dangers. (3) Most of these plants are suspected of toxicity and should therefore be avoided, especially in view of their unproven efficacy. (4) Littleleaf linden, vervain, melissa and orange flower have no demonstrated efficacy but are safe and can therefore be used. Similarly, there are no scientific grounds for rejecting preparations based on hawthorn or passiflora. (5) Available data suggest that valerian extracts have a modest impact on subjective sleep quality; they are nevertheless more effective than a placebo. Valerian products that do not contain valepotriates have no apparent adverse effects. It is best to avoid high-titre alcoholic extracts and powdered valerian root, and to select aqueous extracts and low-titre hydro-alcoholic preparations.

Phytopharmaceuticals containing Valerian are used as mild sleep-inducing agents. The elemental composition of 3 different marks of Valeriana officinalis roots commercially available in the Argentinian market, their teas, and a commercial tincture have been studied. The content of Al, Ca, Cd, Co, Cr, Cu, Fe, Li, Mn, Ni, Pb, V, and Zn was determined in phytopharmaceuticals by flame atomic emission/absorption spectrometry, electrothermal atomic absorption spectrometry, and ultrasonic nebulization coupled to inductively coupled plasma-optical emission spectrometry. Prior to analyses of the samples, a digestion procedure was optimized. The analytical results obtained for Fe, Al, Ca, and V in the solid sample study were within the range 100-1000 mg/kg, and for Mn, Zn, and Pb within the range 10-100 mg/kg. Cadmium was found at levels up to 0.0125 mg/kg.