Review Article

Herbal Medications to Manage Insomnia: An Overview of Clinical Trials using Herbal Treatment for Insomnia

Abstract

Insomnia is one of the most prevalent sleep disorders worldwide which significantly affects the quality of life. Pharmacological and non-pharmacological approaches have been applied in managing insomnia. The risk of tolerance and dependence on conventional medications and their other side effects leads the surveys to complementary and alternative medicine. This overview aimed to compile the clinical trials on herbal remedies in managing insomnia for facilitating future studies on medicinal plant in this issue. The keywords “Medicinal plant”, “Herbal medicine” in combination with “Hypnotic and sedative”, "Insomnia" or "Sleep" were searched through PubMed, Google Scholar, and Scopus electronic databases from 1st January 2000 to 31st August 2020. Then, all clinical trials focusing on the efficacy of medicinal plants on insomnia were collected. Based on the inclusion and exclusion criteria, 36 articles were selected, included 16 medicinal plants (23 studies) as a single herb and 13 polyherbal formulations. The most prevalent route of administration among these trials was oral. Matricaria chamomilla L., Valeriana officinalis L., Viola odorata L., and Passiflora incarnata L. were among the most prevalent effective herbal medicines on insomnia. Also, the modulation of the GABAergic system was the most common target of these medicinal plants. Herbal remedies can be introduced as safe and effective alternatives for conventional medications in managing insomnia. The popular herbal medicines, such as M. chamomilla, V.  officinalis, V. odorata, are suitable for further therapeutic development. Other cited medicinal plants in this review can be more investigated in improvement of sleep.

Winkelman JW. Insomnia disorder. N Engl J Med 2015;373:1437-1444.

Zeng L-N, Zong Q-Q, Yang Y, Zhang L, Xiang Y-F, et al. Gender difference in the prevalence of insomnia: a meta-analysis of observational studies. Front Psychiatry 2020;11:577429.

Jansson-Fröjmark M, Norell-Clarke A. The cognitive treatment components and therapies of cognitive behavioral therapy for insomnia: A systematic review. Sleep Med Rev 2018;42:19-36.

Brownlow JA, Miller KE, Gehrman PR. Insomnia and cognitive performance. Sleep Med Clin 2020;15:71-76.

Cunnington D, Junge MF, Fernando AT. Insomnia: prevalence, consequences and effective treatment. Med J Aust 2013;199:36-40.

Ranjbar M, Firoozabadi A, Salehi A, Ghorbanifar Z, Zarshenas MM, et al. Effects of herbal combination (Melissa officinalis L. and Nepeta menthoides Boiss. & Buhse) on insomnia severity, anxiety and depression in insomniacs: randomized placebo controlled trial. Integr Med Res 2018;7:328-332.

Basnet S, Merikanto I, Lahti T, Männistö S, Laatikainen T, et al. Associations of common chronic non-communicable diseases and medical conditions with sleep-related problems in a population-based health examination study. Sleep Sci 2016;9:249-254.

Khaled SM, Petcu C, Al-Thani MA, Al-Hamadi AMHA, Daher-Nashif S, et al. Prevalence and associated factors of DSM-5 insomnia disorder in the general population of Qatar. BMC Psychiatry 2021;21:84.

Frase L, Nissen C, Riemann D, Spiegelhalder K. Making sleep easier: pharmacological interventions for insomnia. Expert Opin Pharmacother 2018;19:1465-1473.

Neubauer DN, Pandi-Perumal SR, Spence DW, Buttoo K, Monti JM. Pharmacotherapy of insomnia. J Cent Nerv Syst Dis 2018;10:1179573518770672.

Schroeck JL, Ford J, Conway EL, Kurtzhalts KE, Gee ME, et al. Review of safety and efficacy of sleep medicines in older adults. Clin Ther 2016;38:2340-2372.

Ranjbar M, Salehi A, Rezaeizadeh H, Zarshenas MM, Sadeghniiat-Haghighi K, et al. Efficacy of a combination of melissa officinalis L. and nepeta menthoides boiss. & buhse on insomnia: a triple-blind, randomized placebo-controlled clinical trial. J Altern Complement Med 2018;24:1197-1203.

Akram M, Daniyal M, Munir N, Mohiuddin E, Sultana S. Medicinal plants combating against insomnia: a green anti-insomnia approach. J Nerv Ment Dis 2019;207:927-935.

Petramfar P, Zarshenas MM, Moein M, Mohagheghzadeh A. Management of insomnia in traditional Persian medicine. Complement Med Res 2014;21:119-125.

Pour ZS, Hosseinkhani A, Asadi N, Shahraki HR, Vafaei H, et al.*. Double-blind randomized placebo-controlled trial on efficacy and safety of Lactuca sativa L. seeds on pregnancy-related insomnia. J Ethnopharmacol 2018;227:176-180.

Ranjbar M, Afsharypuor S, Shakibaei F, Mazaheri M. Effect of topical lettuce (Lactuca sativa L.) seed oil on childhood sleep disorders: a randomized double-blind controlled trial. Res J Pharmacogn 2020;7:47-54.

Rashidi S, Shafie D, Mazaheri M, Babaei S. Effect of matricaria chamomilla drop on sleep quality in patients with chronic heart disease: a randomized controlled trial. Arch Pharma Pract 2020;11:162-167.

Zick SM, Wright BD, Sen A, Arnedt JT. Preliminary examination of the efficacy and safety of a standardized chamomile extract for chronic primary insomnia: a randomized placebo-controlled pilot study. BMC Complement Altern Med 2011;11:78.

Adib-Hajbaghery M, Mousavi SN. The effects of chamomile extract on sleep quality among elderly people: a clinical trial. BMC Complement Altern Med 2017;35:109-114.

Feyzabadi Z, Rezaeitalab F, Badiee S, Taghipour A, Moharari F, et al. Efficacy of violet oil, a traditional iranian formula, in patients with chronic insomnia: a randomized, double-blind, placebo-controlled study. J Ethnopharmacol 2018;214:22-28.

Feyzabadi Z, Jafari F, Kamali SH, Ashayeri H, Badiee Aval S, et al. Efficacy of viola odorata in treatment of chronic insomnia. Iran Red Crescent Med J 2014;16:e17511.

Shayesteh M, Vaez-Mahdavi MR, Shams J, Kamalinejad M, Faghihzadeh S, et al. Effects of viola odorata as an add-on therapy on insomnia in patients with obsession or depression: a pilot randomized double-blind placebo-controlled trial. J Altern Complement Med 2020;26:398-408.

Afrasiabian F, Mirabzadeh Ardakani M, Rahmani K, Azadi NA, Alemohammad ZB, et al. Aloysia citriodora Palau (lemon verbena) for insomnia patients: a randomized, double‐blind, placebo‐controlled clinical trial of efficacy and safety. Phytother Res 2019;33:350-359.

Shahdadi H, Balouchi A, Dehghanmehr S. Effect of saffron oral capsule on anxiety and quality of sleep of diabetic patients in a tertiary healthcare facility in southeastern iran: a quasi-experimental study. Trop J Pharm Res 2017;16:2749-2753.

Haghjoo E, Haghighi KS, Dabaghian FH, Shojaii A, Mohammadi Kenari H. Efficacy of pumpkin oil (a Persian medicine product) in the treatment of chronic insomnia: a randomized double-blind clinical trial. J Pharm Pharmacogn Res 2019;7:471-481.

Kuratsune H, Umigai N, Takeno R, Kajimoto Y, Nakano T. Effect of crocetin from Gardenia jasminoides Ellis on sleep: a pilot study. Phytomedicine : Phytomedicine 2010;17:840-843.

Nasiri Lari Z, Hajimonfarednejad M, Riasatian M, Abolhassanzadeh Z, Iraji A, et al. Efficacy of inhaled lavandula angustifolia mill. essential oil on sleep quality, quality of life and metabolic control in patients with diabetes mellitus type II and insomnia. J Ethnopharmacol 2020;251:112560.

Soltanpour A, Alijaniha F, Naseri M, Kazemnejad A, Heidari MR. Effects of melissa officinalis on anxiety and sleep quality in patients undergoing coronary artery bypass surgery: a double-blind randomized placebo controlled trial. Eur J Integr Med 2019;28:27-32.

Ngan A, Conduit R. A double-blind, placebo-controlled investigation of the effects of Passiflora incarnata (passionflower) herbal tea on subjective sleep quality. Phytother Res 2011;25:1153-1159.

Ghafarzadeh J, Sadeghniiat-Haghighi K, Sadeghpour O, Akbarpour S, Amini-Behbahani F. Investigating the prevalence of sleep disorder and the impact of sweet almond on the quality of sleep in students of Tehran, Iran. Iran J Public Health 2019;48:1149.

Keyhanmehr AS, Movahhed M, Sahranavard S, Gachkar L, Hamdieh M, et al. The effect of aromatherapy with rosa damascena essential oil on sleep quality in children. Res J Pharmacogn 2018;5:41-46.

Tokinobu A, Yorifuji T, Tsuda T, Doi H. Effects of ayurvedic oil-dripping treatment with sesame oil vs. with warm water on sleep: a randomized single-blinded crossover pilot study. J Altern Complement Med 2016;22:52-58.

Dominguez RA, Bravo-Valverde RL, Kaplowitz BR, Cott JM. Valerian as a hypnotic for hispanic patients. Cultur Divers Ethnic Minor Psychol 2000;6:84-92.

Thomas K, Canedo J, Perry PJ, Doroudgar S, Lopes I, et al. Effects of valerian on subjective sedation, field sobriety testing and driving simulator performance. Accid Anal Prev 2016;92:240-244.

Bagheri-Nesami M, Gorji MAH, Rezaie S, Pouresmail Z, Cherati JY. Effect of acupressure with valerian oil 2.5% on the quality and quantity of sleep in patients with acute coronary syndrome in a cardiac intensive care unit. J Tradit Complement Med 2015;5:241-247.

Herrera-Arellano A, Luna-Villegas G, Cuevas-Uriostegui ML, Alvarez L, Vargas-Pineda G, et al. Polysomnographic evaluation of the hypnotic effect of valeriana edulis standardized extract in patients suffering from insomnia. Planta Med 2001;67:695-699.

Feyzabadi Z, Rezaeitalab F, Badiee S, Taghipour A, Moharari F, et al. Efficacy of violet oil, a traditional Iranian formula, in patients with chronic insomnia: a randomized, double-blind, placebo-controlled study. J Ethnopharmacol 2018;214:22-28.

Langade D, Kanchi S, Salve J, Debnath K, Ambegaokar D. Efficacy and safety of ashwagandha (Withania somnifera) root extract in insomnia and anxiety: a double-blind, randomized, placebo-controlled study. Cureus 2019;11:e5797.

Baek Y, Kim H, Mun S, Lee S. Three-component herbal tea alleviates prolonged fatigue and improves sleep quality: a randomized controlled pilot study. Explore 2018;14:420-423.

Lemoine P, Bablon JC, Da Silva C. A combination of melatonin, vitamin B6 and medicinal plants in the treatment of mild-to-moderate insomnia: a prospective pilot study. Complement Ther Med 2019;45:104-108.

Jacobs BP, Bent S, Tice JA, Blackwell T, Cummings SR. An internet-based randomized, placebo-controlled trial of kava and valerian for anxiety and insomnia. Medicine 2005;84:197-207.

Maroo N, Hazra A, Das T. Efficacy and safety of a polyherbal sedative-hypnotic formulation NSF-3 in primary insomnia in comparison to zolpidem: a randomized controlled trial. Indian J Pharmacol 2013;45:34-39.

Morin CM, Koetter U, Bastien C, Ware JC, Wooten V. Valerian-hops combination and diphenhydramine for treating insomnia: a randomized placebo-controlled clinical trial. Sleep 2005;28:1465-1471.

Palmieri G, Contaldi P, Fogliame G. Evaluation of effectiveness and safety of a herbal compound in primary insomnia symptoms and sleep disturbances not related to medical or psychiatric causes. Nat Sci Sleep 2017;9:16316-16319.

Gammoh OS, Al-Smadi A, Mukattash T, Al-Katib W, Attarian H, et al. Efficacy of single dose antihistamine vs. single dose valerian-hops in subjective sleep measures among war refugees: a comparison trial. Arch Clin Psychiatry 2017;44:35-39.

Wheatley D. Stress-induced insomnia treated with kava and valerian: singly and in combination. Hum Psychopharmacol 2001;16:353-356.

Taherzadeh Z, Khaluyan H, Iranshahy M, Rezaeitalab F, Eshaghi Ghalibaf MH, et al. Evaluation of sedative effects of an intranasal dosage form containing saffron, lettuce seeds and sweet violet in primary chronic insomnia: a randomized, double-dummy, double-blind placebo controlled clinical trial. J Ethnopharmacol 2020;262:113116.

Farag NH, Mills PJ. A randomised-controlled trial of the effects of a traditional herbal supplement on sleep onset insomnia. Complement Ther Med 2003;11:223-225.

Lee JY, Oh HK, Ryu HS, Yoon SS, Eo W, et al. Efficacy and safety of the traditional herbal medicine, gamiguibi-tang, in patients with cancer-related sleep disturbance: a prospective, randomized, wait-list-controlled, pilot study. Integr Cancer Ther 2018;17:524-530.

Li H, Yan X, Li T, Xu J, Wang Q, et al. Efficacy of huadananshen mistura on insomnia: a randomized, double-blind, placebo-controlled, and multi-center clinical trial. J Tradit Chin Med 2013;33:423-427.

Morin CM, Belleville G, Bélanger L, Ivers H. The insomnia severity index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep 2011;34:601-608.

Veqar Z, Moiz JA, Hussain ME. Psychometric analysis of the pittsburgh insomnia rating scale among university population of poor sleepers in india. N Am J Med Sci 2014;6:161-167.

Manzar MD, Salahuddin M, Maru TT, Alghadir A, Anwer S, et al. Validation of the adapted Leeds sleep evaluation questionnaire in Ethiopian university students. Health Qual Life Outcomes 2018;16:49.

Zisapel N, Nir T. Determination of the minimal clinically significant difference on a patient visual analog sleep quality scale. J Sleep Res 2003;12:291-298.

Guo H, Wei M, Ding W. Changes in cognitive function in patients with primary insomnia. Shanghai Arch Psychiatry 2017;29:137-145.

Roozbahani F, Kariman N, Mojab F, Nasiri M. Effect of myrtus communis capsule on vaginal candidiasis treatment. Pajoohandeh Journal 2013;18:242-249.

Kao C-C, Huang C-J, Wang M-Y, Tsai P-S. Insomnia: prevalence and its impact on excessive daytime sleepiness and psychological well-being in the adult Taiwanese population. Qual Life Res 2008;17:1073-1080.

Liu L, Liu C, Wang Y, Wang P, Li Y, et al. Herbal medicine for anxiety, depression and insomnia. Curr Neuropharmacol 2015;13:481-493.

Hieu TH, Dibas M, Surya Dila KA, Sherif NA, Hashmi MU, et al. Therapeutic efficacy and safety of chamomile for state anxiety, generalized anxiety disorder, insomnia, and sleep quality: a systematic review and meta‐analysis of randomized trials and quasi‐randomized trials. Phytother Res 2019;33:1604-1615.

Shinjyo N, Waddell G, Green J. Valerian root in treating sleep problems and associated disorders- a systematic review and meta-analysis. J Evid Based Integr Med 2020;25:2515690X20967323.

Fazeenah AA, Quamri MA. Banafsha (viola odorata linn.)-a review. World J Pharm Res 2020;9:514-537.

Feyzabadi Z, Ghorbani F, Vazani Y, Zarshenas MM. A critical review on phytochemistry, pharmacology of Viola odorata L. and related multipotential products in traditional Persian medicine. Phytother Res 2017;31:1669-1675.

Appel K, Rose T, Fiebich B, Kammler T, Hoffmann C, et al. Modulation of the γ‐aminobutyric acid (GABA) system by Passiflora incarnata L. Phytother Res 2011;25:838-843.

Janda K, Wojtkowska K, Jakubczyk K, Antoniewicz J, Skonieczna-Żydecka K. Passiflora incarnata in neuropsychiatric disorders- a systematic review. Nutrients 2020;12:3894.

Carrasco MC, Vallejo JR, Pardo‐de‐Santayana M, Peral D, Martín MÁ, et al. Interactions of Valeriana officinalis L. and Passiflora incarnata L. in a patient treated with lorazepam. Phytother Res 2009;23:1795-1796.

Files
IssueVol 7, No 2, 2022 QRcode
SectionReview Article(s)
DOI https://doi.org/10.18502/tim.v7i2.9928
Keywords
Herbal medicine Hypnotics Insomnia Medicinal plant Sedative Sleep

Rights and permissions
Creative Commons License This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
How to Cite
1.
Ranjbar M, Mazaheri M, Ansaripour M, Babaeian M, Jalali A, Zarshenas MM. Herbal Medications to Manage Insomnia: An Overview of Clinical Trials using Herbal Treatment for Insomnia. Trad Integr Med. 2022;7(2):254-265.