<h2>Practice points</h2><ul><li>Valerian may improve time taken to fall asleep and sleep quality. It should be taken approximately 1 hour prior to bedtime. Continuous nightly use of valerian may be needed for significant effect for some people</li><li>Hops may improve sleep quality and is commonly used in combination with valerian</li><li>Lemon balm may improve sleep but trial evidence is limited</li></ul><ul><li> <ul><li> <h2>Description</h2> </li><li> <ul><li>Insomnia affects up to 40% of the population.1 Diagnosed chronic insomnia affects around 10% of the population2</li><li>The prevalence of general sleep disturbance experienced by people over a year is approximately 85%2</li><li>There are four types of insomnia: (1) difficulty falling asleep; (2) difficulty maintaining sleep; (3) early morning awakening; or (4) unrefreshing sleep3</li><li>Insomnia typically presents as an isolated episode, but may denote an underlying medical condition or situation1</li><li>Insomnia is linked to increased risk of other conditions or comorbidities such as hypertension, cardiovascular disease, anxiety and depression1,4</li></ul> </li></ul> </li></ul>

<h2>Management guidelines</h2><ul><li>Improve sleep quantity and quality5</li><li>Improve daytime alertness and concentration5</li><li>Minimise incidence of adverse drug effects5</li><li>Start with non-pharmacologic therapy. Employ hypnotics when an immediate response is required, if there is serious impairment, if non-pharmacologic approaches haven’t produced the desired improvement or when insomnia persists after treatment of an underlying condition5</li></ul>

Management

<h2>Primary recommendations</h2><h2>VALERIAN (Valeriana officinalis)</h2>Mechanism of action<ul><li>May stimulate release of GABA, inhibit GABA reuptake and modulate GABA activity at GABA(A) receptors6,7</li></ul>ResearchMost research shows that taking valerian orally modestly reduces the time to sleep onset (sleep latency), and improves subjective sleep quality although not all evidence is positive.8<ul><li> A 2010 meta-analysis (18 RCTs; n=1317) found that valerian improved subjective sleep quality, although this was not confirmed by quantitative measurements9</li><li> A 2011 systematic review found 3 positive (more effective than placebo and equivalent to oxazepam) and 3 negative results (equal to placebo)2</li><li> A 2015 systematic review and meta-analysis (14 RCTs; n=1602) found no statistically significant difference between valerian and placebo for 13 measures of clinical efficacy1</li><li> Some research suggests valerian in combination with hops may improve sleep latency and duration8</li><li> Valerian does not relieve insomnia as fast as benzodiazepines, however it may improve sleep quality in those withdrawing from these drugs8</li><li> Morning drowsiness is rare at standard doses due to improvement of sleep parameters and no inhibition of REM sleep phases10</li><li> No increase in alcohol toxicity if combined10</li><li> No adverse effects shown in driving studies10</li></ul>Dosage<ul><li>Typically found in tablet/capsule form</li><li>Standardised extracts that report valerenic acid content may be more reliable7</li><li>Dosage range: &gt; 600 mg/d dried root 1h before bedtime. Infusion of ≥9 g/day dried root7</li></ul>Adverse effects<ul><li>May occasionally cause headache, GI symptoms, morning somnolence, and vivid dreams7</li></ul>Key interactionsOther sedatives eg. alcohol - use combination with caution.<ul><li> Benzodiazepines: may have an additive effect to drug by binding to the GABA receptors. Case report evidence. Recommended to avoid concomitant use14</li><li>CYP450 enzyme substrates (CYP3A4, CYP2D6): may increase or decrease blood levels of drug via inhibition of these enzyme activities. Evidence suggests this interaction can occur, but is not likely to occur in many patients. Use with caution under supervision of healthcare professional (HCP)14</li><li>Efavirenz: may act on GABA-A receptor and boost melatonin release. Clinical trial (4-week treatment of valerian 530 mg at night 1 hour before sleep improved neuropsychiatric adverse effects of efavirenz such as anxiety and insomnia). Use with caution under supervision of HCP14</li></ul> For more information on key interactions visit: <a href="~/link.aspx?_id=4471DACF65C148EA8FD82B23FD6712D4&_z=z">https://www.blackmoresinstitute.org/interactions</a>

Primary

<h2>Secondary recommendations</h2><h2>HOPS (Humulus lupulus)</h2>Mechanism of action<ul><li>May modulate activity of GABA via modulation of brain GABA(A) receptors as well as effects on adenosine, serotonin and melatonin11</li></ul>ResearchHops have been commonly used in combination with valerian<ul><li>A 2010 systematic review of randomised controlled trials found hops and valerian combination improved at least one sleep parameter, often sleep latency and sleep quality in patients with primary insomnia. There were, however, methodological problems and further studies are needed12</li><li> A 2008 randomised controlled trial found a hops/valerian combination improved sleep quality and duration after single-dose administration13</li></ul>Dosage<ul><li>Typically found in tablet/capsule form</li><li>Dosage range: equivalent to 500 – 3 g dried herb/d7</li><li>Also used as a bath additive and in pillows7</li></ul>Adverse effects<ul><li>Contact with herb or oil may result in systemic urticaria, allergic dermatitis, respiratory allergy, and anaphylaxis7</li></ul>Key interactions<ul><li>CYP450 enzyme substrates (1A1, 1A2, 1B1, 2C8, 2C9, 2C19, 3A4): may increase drug effects and blood levels of affected medications14</li></ul><h2>LEMON BALM (Melissa officinalis)</h2>Mechanism of action<ul><li>Anxiolytic7</li><li>Sedative7</li></ul>ResearchStudies of valerian and lemon balm in combination included: <ul><li>A randomised, double-blind multicenter study investigated the effects of a commercial valerian and lemon balm herbal combination in 98 healthy subjects over a 30-day period and consisted of three tablets taken half an hour before bedtime, providing a total dose of 1-6 g of valerian and 1-2 g lemon balm. Herbal treatment significantly improved sleep quality and was well tolerated7</li><li>Another randomised, double-blind crossover study found that the same combination of valerian and lemon balm taken over 9 nights was as effective as triazolam in the treatment of insomnia. The dose was 1.4 g dried valerian and 0.9 g dried lemon balm7</li><li>Preliminary research suggests that a standardised lemon balm extract may reduce insomnia in patients with mild to moderate anxiety disorders. There were improvements in sleep latency, sleep quality and sleep duration15</li><li>Commission E (European Union Commission on Herbal Monographs) approves the role of lemon balm in the treatment of insomnia</li></ul>Dosage<ul><li>1-2 g of lemon balm in combination with valerian 1-6 g</li></ul>Adverse effects<ul><li>Lemon balm is well-tolerated7</li></ul>Key interactionsControlled clinical studies are not available, so interactions are speculative and based on evidence of activity. <ul><li>Barbiturates: increased sedative effects, observe patients taking this combination7</li><li>Cholinergic drugs: additive effects are theoretically possible and may be beneficial, observe patients taking this combination7</li></ul> For more information on key interactions visit: <a href="~/link.aspx?_id=4471DACF65C148EA8FD82B23FD6712D4&_z=z">https://www.blackmoresinstitute.org/interactions</a>

Secondary

<h2>Diet and lifestyle recommendations </h2><ul><li>Decrease body-mass index4</li><li>Increase exercise and physical activity4,5</li><li>Lower caffeine coffee, tea and caffeine containing energy and sports drinks3,4</li><li>Maintain a regular sleep schedule3</li><li>Avoid large meals before bedtime3</li><li>Yoga and tai chi may improve sleep duration or quality2</li><li>Good evidence supports cognitive behavioural therapy and relaxation therapy5</li></ul>

Diet & lifestyle

<h2>References</h2>1. Leach MJ, Page AT. Herbal medicine for insomnia: A systematic review and meta-analysis. Sleep Med Rev 2015; 24:1-12. 2. Sarris J, Byrne GJ. A systematic review of insomnia and complementary medicine. Sleep Med Rev 2011; 15(2):99-106. 3. Natural Medicines Comprehensive Database (Health Professional Edition). Natural Medicines in the Clinical Management of Insomnia http://naturaldatabase.therapeuticresearch.com/ce/ceCourse.aspx?s=ND&amp;cs=&amp;pm=5&amp;pc=11-101 Accessed 18 May 2016. 4. Merrill RM, Aldana SG, Greenlaw RL, et al. The effects of an intensive lifestyle modification program on sleep and stress disorders. J Nutr Health Aging 2007; 11(3):242-8. 5. Ramakrishnan K, Scheid DC. Treatment options for insomnia. Am Fam Physician 2007; 76(4):517-26. 6. Gooneratne NS. Complimentary and alternative medicine for sleep disturbances in older adults. Clin Geriatr Med 2008; 24(1):121-38. 7. Braun L, Cohen M. Herbs &amp; Natural Supplements. 3rd ed. Chatswood: Elsevier; 2010. 8. Natural Medicines 2016. Valerian Professional Monograph Bent S, Padula A, Moore D, et al. Valerian for sleep: s systematic review and meta-analysis. Am J Med 2006; 119(12):1005-12. 9. Fernández-San-Martín MI, Masa-Font R, Palacios-Soler L, et al. Effectiveness of Valerian on insomnia: a metaanalysis of randomized placebo-controlled trials. Sleep Med 2010; 11(6):505-11. 10. Bone K, Mills S. Principles and Practice of Phytotherapy. Elsevier 2013 11. Juanez JC. Hops (Humulus lupulus L) and beer: benefits on the sleep. J Sleep Disord Ther. 2012; 1:102. 12. Salter S, Brownie S. Treating primary insomnia: the efficacy of valerian and hops. Aust Fam Physician 2010; 39(6):433-7. 13. Dimpfel W, Suter A. Sleep improving effects of a single dose administration of a valerian/hops fluid extract – a double blind, randomised, placebo-controlled sleep-EEG study in a parallel design using eletrohypnograms. Eur J Med Res 2008:13(5):200-4 14. Blackmores Institute Complementary Medicines Interaction Guide; 2016. 15. Cases J. Leaf extract in the treatment of volunteers suffering from mild-to-moderate anxiety disorders and sleep disturbances. Mediterr J Nutr Metab 2010; 4(3):211-8.

Insomnia

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