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Monograph Library
Valericalm®

Valericalm®

(Valerian Combo)

Sleep and Anxiety


NPN 80037959

 

Sleep problems and nervous disorders: the pitfalls of the pharmaceutical approach

Anxiety disorders and insomnia often go hand in hand and are highly comorbid.[1] Anxiety disorders afflict one in five people worldwide at some point or other in their lives, while it is speculated that insomnia affects between 9 and 15% of people globally.[2] The American Academy of Sleep Medicine points out that, among adults in the U.S., 30 to 35% suffer brief episodes of insomnia, 15 to 20% have short-term insomnia, and 10% have a chronic insomnia disorder. The symptoms are broad and debilitating: fatigue, inability to maintain focus and concentration, poor memory, mood disturbance, daytime sleepiness, low motivation or energy, proneness to errors and accidents.[3] Also, epidemiological research suggests that there is a correlation between insomnia and other more serious health risks, including anxiety disorders and other psychological problems, as well as hypertension and decreased immune function.[4],[5]

Comprehensive reviews have shown that a therapy based on anxiolytic and hypnotic pharmaceutical drugs (e.g. benzodiazepines and other drugs) is associated with a significantly increased risk of mortality.[6],[7] This is not to mention the dangers posed by dependence and side-effects like gastrointestinal upset, vertigo, and fatigue.[8]

 

A better, more natural solution

Research shows that, for problems of anxiety and insomnia, nervine herbs offer an effective solution that is both safer and non-addictive.[9],[10],[11]


This formula is aptly named after valerian, a classic nervine herb with anxiolytic properties.[12] Its use can be traced back to classical antiquity. In the time of the Roman Empire, we find Galen, for example, prescribing it for insomnia.[13] Closer to our own day,
valerian was widely employed by the Eclectics—physicians of the 19th and early 20th centuries who tended to rely on herbal therapies--for treating nervousness, restlessness and anxiety as well as insomnia.[14],[15]

 

In a double-blind trial of 48 adults, valerian was found to reduce anxiety without ancillary sedation,[16] while another clinical trial that used a standardized valerian preparation showed an anxiety-reducing effect similar to diazepam.[17] As well, several studies present compelling evidence of the effectiveness of valerian in the treatment of insomnia.[18] These include a clinical trial with 202 patients that found valerian and oxazepam, a standard benzodiazepine tranquilizer, to be equally efficacious.[19] It is thought that valerian’s mechanism of action is through GABA neurotransmitters.[20]

 

A beautiful climbing plant, passion flower was introduced to Europe from the Americas by the Spanish in the 16th century. Afterwards it became popular in Western medicine as a tranquilizer and mild sedative. Eclectic physicians found it “specially useful” to treat insomnia and restlessness.[21] More recently, a study with 41 participants that featured a double-blind, placebo-controlled, repeated-measures design found passion flower to improve sleep quality significantly.[22] Human clinical trials have also demonstrated its anxiolytic activity.[23],[24] Animal models suggest that passion flower may be effective for neuropathic pain,[25] as well as stress reduction and improving memory.[26] It has been suggested that its mechanism of action occurs through gamma-aminobutyric acid (GABA) receptors.[27]

 

Native Americans used the California poppy for its relatively mild sedative and analgesic properties.[28] Modern research studies have confirmed not only its sedative and analgesic actions, but its anxiolytic qualities as well.[29],[30],[31] The therapeutic effects of California poppy are thought to arise from the binding of its alkaloids with opioid receptors and other neurotransmitter activity.[32],[33]

 

The therapeutic use of chamomile can be traced back to ancient Egyptian, Greek, and Roman cultures.[34] The Eclectics valued it for calming the nervous system.[35] A long-term double-blind randomized controlled trial using chamomile extract found that it significantly reduced moderate to severe symptoms of GAD (generalized anxiety disorder).[36] In addition, a short-term open label trial of chamomile extract showed a clinically meaningful reduction in symptoms of GAD over 8 weeks with results comparable to those of conventional anxiolytic drug therapy.[37]

 

A climbing plant best known as a bittering agent in beer, hops has a long history of therapeutic use as a sedative in a wide range of cultures, including those of India and China,[38] as well as the indigenous peoples of North America.[39] A clinical trial using a combination of hops and valerian for patients suffering sleep disorders according to DSM-IV criteria has demonstrated an effectiveness equivalent to benzodiazepine drugs.[40] Other studies confirm the sedative action of hops for promoting sleep.[41],[42],[43] Its pharmacological action is attributable to its bitter resins, which amplify the action of neurotransmitter g-aminobutyric (GABA), inhibiting the central nervous system (CNS).[44]

 

A perennial and member of the mint family, motherwort can now be found worldwide, although it originates from temperate parts of Europe and Asia.[45] Native Americans used it as a sedative among other things.[46] Similarly, the Eclectics considered it a tonic nervine for chronic diseases accompanied by restlessness and disturbed sleep.[47] Research confirms the sedative activity of motherwort.[48] A clinical trial with an oil extract of motherwort found it to be hypotensive, as well as significantly mitigating anxiety and sleep disorders.[49] Like other anxiolytic herbs, it is thought to work by way of GABA receptors.[50]

 

Active Ingredients (per ml):

  • 20 ml of valerian (Valeriana officinalis, root and rhizome) tincture (1:4, QCE 50 mg dry OR 1:1, QCE 200 mg fresh)
  • 20 ml of passionflower (Passiflora incarnata, herb top) tincture (1:4, QCE 50 mg dry OR 1:1, QCE 200 mg fresh)
  • 20 ml of California poppy (Eschscholzia californica, herb top) tincture 1:4 (QCE 50 mg)
  • 16 ml of chamomile (Matricaria chamomilla, flower) tincture 1:4 (QCE 40 mg)
  • 14 ml of hops (Humulus lupulus, strobile) tincture 1:4 (QCE 35 mg)
  • 10 ml of motherwort (Leonurus cardiaca, herb top) tincture 1:4 (QCE 25 mg)

 

QCE = Quantity Crude Equivalent

 

Non-Medicinal Ingredients: Certified Organic alcohol, Distilled water, Certified Organic vegetable glycerine

 

Recommended Dose:

Adults: Take 2 ml (60 drops) 3 times daily in a little water on an empty stomach. When used as a sleep aid, the full 6 ml (180 drops) daily dose may be taken in a little water on an empty stomach at bedtime.

 

Duration of Use:

For long-term use, contact your health care practitioner.

 

Health Canada Approved Use Claims

Used in Herbal Medicine as a sleep aid and to help relieve nervousness (calmative/sedative). California Poppy is traditionally used in Herbal Medicine as an analgesic.

 

Cautions and Warnings

Consult a health care practitioner: if sleeplessness persists continuously for more than 3 weeks (chronic insomnia); if symptoms worsen. Consumption with alcohol, other medications, or natural health products with sedative properties is not recommended. Consult a health care practitioner before use: if you are breastfeeding; if you have depression and/or related diseases.

 

Contraindications

Do not use: if you are pregnant; if you are allergic to plants of the Asteraceae/Compositae/Daisy family.

 

Known Adverse Reactions

Some people may experience drowsiness. Exercise caution if operating heavy machinery, driving a motor vehicle, or involved in activities requiring mental alertness. Hypersensitivity (e.g. allergy) has been known to occur, in which case, discontinue use.

 

Quality Summary

Our products are all third party tested to ensure the absence of pesticides, microbes, and heavy metals and to confirm purity and stability.

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References

  1.  J Sarris et al, “Plant-Based Medicines for Anxiety Disorders, Part 1,” CNS Drugs 2013; 27: 207-219.
  2.  L Liu et al, “Herbal Medicine for Anxiety, Depression and Insomnia,” Current Neuropharmacology 2015; 12: 481-493.
  3.  Thomas M Heffron, “Insomnia Awareness Day facts and stats,” Sleep Education: A sleep health information resource by the American Academy of Sleep Medicine 2014 March; accessed online at: http://www.sleepeducation.org/news/2014/03/10/insomnia-awareness-day-facts-and-stats
  4.  DJ Taylor et al, “Insomnia as a health risk factor,” Behavioural Sleep Medicine 2003; 1(4): 227-47.
  5.  Heffron, op.cit.
  6.  S Weich et al, “Effect of anxiolytic and hypnotic drug prescriptions on mortality hazards: retrospective cohort study,” BMJ 2014 March; 348.
  7.  AK Parsaik et al, “Mortality associated with anxiolytic and hypnotic drugs—A systematic review and meta-analysis,” Australian and New Zealand Journal of Psychiatry 2016 June; 50(6): 520-33.
  8.  K Abascal and E Yarnell, “Nervine Herbs for Treating Anxiety,” Alternative and Complementary Therapies 2004 December; 309-315.
  9.  J Sarris, op. cit.
  10.  J Sarris et al, “Plant-Based Medicines for Anxiety Disorders, Part 2: A Review of Clinical Studies With Supporting Preclinical Evidence,” CNS Drugs 2013; 27: 301-319.
  11.  L Liu, op. cit.
  12.  M Hattesohl et al, “Extracts of Valeriana officinalis L. s.l. show anxiolytic and antidepressant effects but neither sedative nor myorelaxant properties,” Phytomedicine 2008 January; 15(1-2): 2-15.
  13.  Mark Blumenthal et al, eds, “Valerian Root,” Herbal Medicine: Expanded Commission E Monographs, Newton, MA: Integrative Medicine Communications, 2000, pp. 394-400.
  14.  Finley Ellingwood, The American Materia Medica, Therapeutics and Pharmacognosy, Portland, OR: Eclectic Medical Publications; 1985. Reprinted from original 1919 edition, p. 125.
  15.  WH Cook, The Physio-medical Dispensatory, 1869, Scanned version copyright Henrietta Kress, 2001. Accessed from: http://tinyurl.com/2jr2vo
  16.  R Kohnen and WD Oswald, “The effects of valerian, propranolol, and their combination on activation, performance, and mood of healthy volunteers under social stress conditions,” Pharmopsychiatry 1988 November; 21(6): 447-8.
  17.  R Andreatini et al, “Effect of valepotriates (valerian extract) in generalized anxiety disorder: a randomized placebo-controlled pilot study,” Phytotherapy Research 2002 November; 16(7): 650-4.
  18.  “Valeriana officinalis,” Alternative Medicine Review 2004; 9(4): 438-441.
  19.  G Ziegler et al., Eur J Med Res 2002;7(11):480-6.
  20.  HA Hamid et al, “Indole Alkaloids from Plants as Potential Leads for Antidepressant Drugs: A Mini Review,” Frontiers in Pharmacology 2017 February; 8(96): 1-7.
  21.  HW Felter and JU Lloyd, King’s American Dispensatory, 18th Edition, 3rd Revision, 1898. Vol 2. Reprint edition. Portland, OR: Eclectic Medical Publications, 1983, p. 1440.
  22.  A Ngan and R Conduit, “A double-blind, placebo-controlled investigation of the effects of Passiflora incarnate (passionflower) herbal tea on subjective sleep quality,” Phytotherapy Research 2011 August; 25(8): 1153-9.
  23.  J Sarris et al, “Herbal medicine for depression, anxiety and insomnia: a review of psychopharmacology and clinical evidence,” European Neuropsychopharmacology 2011 December; 21(12): 841-60.
  24.  P Aslanargun et al, “Passiflora incarnata Linnaeus as an anxiolytic before spinal anesthesia,” Journal of Anesthesia 2012 February; 26(1): 39-44.
  25.  U Aman et al, “Passiflora incarnata attenuation of neuropathic allodynia and vulvodynia apropos GABA-ergic and opioidergic antinociceptive and behavioural mechanisms,” BMC Complementary and Alternative Medicine 2016 February; 16:77.
  26.  K Jawna-Zboinksa et al, “Passiflora incarnata L. Improves Spatial Memory, Reduces Stress, and Affects Neurotransmission in Rats,” Phytotherapy Research 2016 May; 30(5): 781-9.
  27.  Jawna-Zboinska, op.cit.
  28.  Daniel E Moerman, Native American Ethnobotany, Portland, OR: Timber Press, 1998, p. 228.
  29.  A Rolland et al, “Behavioural effects of the American traditional plant Eschscholzia californica: sedative and anxiolytic properties,” Planta Medica 1991 June; 57(3): 212-6.
  30.  A Rolland et al, “Neurophysiological effects of an extract of Eschscholzia californica Cham. (Papaveraceae),” Phytotherapy Research 2001 August; 15(5): 377-81.
  31.  J Sarris et al, “Plant-based medicines for anxiety disorders, Part 1: a review of preclinical studies,” CNS Drugs 2013 March; 27(3): 207-19.
  32.  Kerry Bone and Simon Mills, Principles and Practice of Phytotherapy: Modern Herbal Medicine, Second Edition, Edinburgh: Churchill Livingstone, 2013, p. 271.
  33.  M Fedurco et al, “Modulatory Effects of Eschscholzia californica Alkaloids on Recombinant GABAA Receptors,” Biochemistry Research International 2015
  34.  Mark Blumenthal et al, eds, “Chamomile Flower, German,” Herbal Medicine: Expanded Commission E Monographs, Newton, MA: Integrative Medicine Communications, 2000, pp. 57-61.
  35.  HW Felter and JU Lloyd, King’s American Dispensatory, 18th Ed., Vol. 2. Portland, OR: Eclectic Medical Publications, 1983 [Reprint edition], p. 1246.
  36.  JJ Mao et al, “Long-term chamomile (Matricaria chamomilla L.) treatment for generalized anxiety disorder: A randomized clinical trial,” Phytomedicine 2016 December; 23(14): 1735-42.
  37.  JR Keefe et al, “Short-term open-label chamomile (Matricaria chamomilla L.) therapy of moderate to severe generalized anxiety disorder,” Phytomedicine 2016 December; 23(14): 1699-1705.
  38.  Mark Blumenthal et al, eds, “Hops,” Herbal Medicine: Expanded Commission E Monographs, Newton, MA: Integrative Medicine Communications, 2000, pp. 193-196.
  39.  Daniel E Moerman, Native American Ethnobotany, Portland, OR: Timber Press, 1998, pp. 269-270.
  40.  M Schmitz and M Jäckel, [Comparative study for assessing quality of life of patients with exogenous sleep disorders (temporary sleep onset and sleep interruption disorders) treated with a hops-valerian preparation and a benzodiazepine drug], Wiener Medizinische Wochenschrift 1998; 148(13): 291-8. [article in German]
  41.  L Franco et al, “The sedative effect of non-alcoholic beer in healthy female nurses,” PLoS One 2012; 7(7): e37290
  42.  L Franco et al, “Effect of non-alcoholic beer on Subjective Sleep Quantity in a university stressed population,” Acta Physiologica Hungarica 2014 September; 101(3): 353-61.
  43.  P Zanoli et al, “New insight in the neuropharmacological activity of Humulus lupulus L.,” Journal of Ethnopharmacology October 2005; 102(1): 102-106.
  44.  L Franco et al, “The sedative effects of hops (Humulus lupulus), a component of beer, on the activity/rest rhythm,” Acta Physiologica Hungarica 2012 June; 99(2): 133-9.
  45.  Mark Blumenthal et al, eds, “Motherwort Herb,” Herbal Medicine: Expanded Commission E Monographs, Newton, MA: Integrative Medicine Communications, 2000, pp. 267-9.
  46.  Daniel E Moerman, op.cit., p. 301.
  47.  Finley Ellingwood, American Materia Medica, Therapeutics and Pharmacognosy, Chicago: Ellingwood’s Therapeutist, 1915; p. 483.
  48.  K Wojtyniak et al, “Leonurus cardiaca L. (motherwort): a review of its phytochemistry and pharmacology,” Phytotherapy Research 2013 August; 27(8): 1115-20.
  49.  AN Shikove et al, “Effect of Leonurus cardiaca oil extract in patients with arterial hypertension accompanied by anxiety and sleep disorders,” Phytotherapy Research 2011 April; 25(4): 540-3.
  50.  HW Rauwald et al, “GABAA Receptor Binding Assays of Standardized Leonurus cardiaca and Leonurus japonicus Extracts as Well as Their Isolated Constituents,” Planta Medica 2015 August; 81(12-13): 1103-10.

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