Meta-Analysis: Melatonin for the Treatment of Primary Sleep Disorders
Open accessAbstract
Study Objectives: To investigate the efficacy of melatonin compared to placebo in improving sleep parameters in patients with primary sleep disorders. Design: PubMed was searched for randomized, placebo-controlled trials examining the effects of melatonin for the treatment of primary sleep disorders. Primary outcomes examined were improvement in sleep latency, sleep quality and total sleep time. Meta-regression was performed to examine the influence of dose and duration of melatonin on reported efficacy. Participants: Adults and children diagnosed with primary sleep disorders. Interventions: Melatonin compared to placebo. Results: Nineteen studies involving 1683 subjects were included in this meta-analysis. Melatonin demonstrated significant efficacy in reducing sleep latency (weighted mean difference (WMD) = 7.06 minutes [95% CI 4.37 to 9.75], Z = 5.15, p<0.001) and increasing total sleep time (WMD = 8.25 minutes [95% CI 1.74 to 14.75], Z = 2.48, p = 0.013). Trials with longer duration and using higher doses of melatonin demonstrated greater effects on decreasing sleep latency and increasing total sleep time. Overall sleep quality was significantly improved in subjects taking melatonin (standardized mean difference = 0.22 [95% CI: 0.12 to 0.32], Z = 4.52, p<0.001) compared to placebo. No significant effects of trial duration and melatonin dose were observed on sleep quality. Conclusion: This meta-analysis demonstrates that melatonin decreases sleep onset latency, increases total sleep time and improves overall sleep quality. The effects of melatonin on sleep are modest but do not appear to dissipate with continued melatonin use. Although the absolute benefit of melatonin compared to placebo is smaller than other pharmacological treatments for insomnia, melatonin may have a role in the treatment of insomnia given its relatively benign side-effect profile compared to these agents. (Reprinted with permission from PLoS ONE, (8)5: e63773, 2013)
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Overall sleep quality was significantly improved in melatonin users.
“Trials that used higher doses of melatonin and conducted over a longer duration demonstrated even greater effects on these two sleep issues, and overall sleep quality was also significantly improved in melatonin users [1,91].”
From Is Melatonin the “Next Vitamin D”?: A Review of Emerging Science, Clinical Uses, Safety, and Dietary Supplements (2022) · cites this paper as [91]
Trials that used higher doses of melatonin and conducted over a longer duration demonstrated even greater effects on sleep latency and total sleep time.
“Trials that used higher doses of melatonin and conducted over a longer duration demonstrated even greater effects on these two sleep issues, and overall sleep quality was also significantly improved in melatonin users [1,91].”
From Is Melatonin the “Next Vitamin D”?: A Review of Emerging Science, Clinical Uses, Safety, and Dietary Supplements (2022) · cites this paper as [91]
A meta-analysis of melatonin for the treatment of primary sleep disorders analyzed nineteen studies involving 1683 individuals.
“A meta-analysis of melatonin for the treatment of primary sleep disorders analyzed nineteen studies involving 1683 individuals.”
From Is Melatonin the “Next Vitamin D”?: A Review of Emerging Science, Clinical Uses, Safety, and Dietary Supplements (2022) · cites this paper as [91]
Cites
Bias in meta-analysis detected by a simple, graphical test
Egger, M., Smith, G. D., Schneider, M., & Minder, C. (1997) · BMJ · doi:10.1136/bmj.315.7109.629 · Cited by 56,722 · see citing works
Bunney, W. E., Hippius, H., Laakmann, G., & Schmauß, M. (1990) · Springer eBooks · doi:10.1007/978-3-642-74034-3 · Cited by 1,523 · see citing works
Nonpharmacological interventions for insomnia: a meta-analysis of treatment efficacy
(1994) · American Journal of Psychiatry · doi:10.1176/ajp.151.8.1172 · Cited by 1,098 · see citing works
Sleep duration and mortality: a systematic review and meta-analysis
GALLICCHIO, L., & KALESAN, B. (2009) · Journal of Sleep Research · doi:10.1111/j.1365-2869.2008.00732.x · Cited by 979 · see citing works
The basic physiology and pathophysiology of melatonin
Claustrat, B., Brun, J., & Chazot, G. (2004) · Sleep Medicine Reviews · doi:10.1016/j.smrv.2004.08.001 · Cited by 951 · see citing works
Comparative Meta-Analysis of Pharmacotherapy and Behavior Therapy for Persistent Insomnia
Smith, M. T., Perlis, M. L., Park, A., Smith, M. S., Pennington, J., Giles, D. E., & Buysse, D. J. (2002) · American Journal of Psychiatry · doi:10.1176/appi.ajp.159.1.5 · Cited by 863 · see citing works
Neyeloff, J. L., Fuchs, S. C. P. C., & Moreira, L. B. (2012) · BMC Research Notes · doi:10.1186/1756-0500-5-52 · Cited by 731 · see citing works
Identifying effective psychological treatments for insomnia: A meta-analysis.
Murtagh, D. R. R., & Greenwood, K. M. (1995) · Journal of Consulting and Clinical Psychology · doi:10.1037//0022-006x.63.1.79 · Cited by 664 · see citing works
Medical and socio-professional impact of insomnia
Léger, D., Guilleminault, C., Bader, G., Lévy, E., & Paillard, M. (2002) · Sleep · doi:10.1093/sleep/25.6.621 · Cited by 468 · see citing works
The Efficacy and Safety of Drug Treatments for Chronic Insomnia in Adults: A Meta-Analysis of RCTs
Buscemi, N., Vandermeer, B., Friesen, C., Bialy, L., Tubman, M., Ospina, M., Klassen, T. P., & Witmans, M. (2007) · Journal of General Internal Medicine · doi:10.1007/s11606-007-0251-z · Cited by 448 · see citing works
Delayed sleep phase syndrome response to melatonin
Dahlitz, M., Álvarez, B., Parkes, J. D., English, J., Arendt, J., & Vignau, J. (1991) · The Lancet · doi:10.1016/0140-6736(91)92787-3 · Cited by 427 · see citing works
The Direct and Indirect Costs of Untreated Insomnia in Adults in the United States
Ozminkowski, R. J., Wang, S. S., & Walsh, J. K. (2007) · SLEEP · doi:10.1093/sleep/30.3.263 · Cited by 403 · see citing works
The efficacy and safety of exogenous melatonin for primary sleep disorders a meta-analysis
Buscemi, N., Vandermeer, B., Hooton, N., Pandya, R., Tjosvold, L., Hartling, L., Baker, G., Klassen, T. P., & Vohra, S. (2005) · Journal of General Internal Medicine · doi:10.1111/j.1525-1497.2005.0243.x · Cited by 399 · see citing works
Melatonin Replacement Therapy of Elderly Insomniacs
Haimov, I., Lavie, P., Laudon, M., Herer, P., Vigder, C., & Zisapel, N. (1995) · SLEEP · doi:10.1093/sleep/18.7.598 · Cited by 344 · see citing works
Melatonin treatment for age-related insomnia
Zhdanova, I. V., Wurtman, R. J., Regan, M. M., Taylor, J. A., Shi, J. P., & Leclair, O. U. (2001) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/jcem.86.10.7901 · Cited by 308 · see citing works
Kunz, D., & Mahlberg, R. (2010) · Journal of Sleep Research · doi:10.1111/j.1365-2869.2010.00848.x · Cited by 271 · see citing works
Lemoine, P., Nir, T., Laudon, M., & Zisapel, N. (2007) · Journal of Sleep Research · doi:10.1111/j.1365-2869.2007.00613.x · Cited by 261 · see citing works
Wade, A. G., Ford, I., Crawford, G. M., McMahon, A. D., Nir, T., Laudon, M., & Zisapel, N. (2007) · Current Medical Research and Opinion · doi:10.1185/030079907x233098 · Cited by 237 · see citing works
Nagtegaal, J. E., KERKHOF, G. A., Smits, M. G., Swart, & van der Meer, Y. G. (1998) · Journal of Sleep Research · doi:10.1046/j.1365-2869.1998.00102.x · Cited by 221 · see citing works
Phase-Dependent Treatment of Delayed Sleep Phase Syndrome with Melatonin
Mundey, K., Benloucif, S., Harsanyi, K., Dubocovich, M. L., & Zee, P. C. (2005) · SLEEP · doi:10.1093/sleep/28.10.1271 · Cited by 218 · see citing works
Melatonin for Chronic Sleep Onset Insomnia in Children: A Randomized Placebo-Controlled Trial
Smits, M. G., Nagtegaal, E., van der Heijden, J., Coenen, A. M. L., & KERKHOF, G. A. (2001) · Journal of Child Neurology · doi:10.1177/088307380101600204 · Cited by 211 · see citing works
The prevalence, cost implications, and management of sleep disorders: an overview
Hossain, J. L., & Shapiro, C. M. (2002) · Sleep And Breathing · doi:10.1055/s-2002-32322 · Cited by 195 · see citing works
Smits, M. G., van Stel, H. F., der Heijden, K. V., Meijer, A. M., Coenen, A. M. L., & KERKHOF, G. A. (2003) · Journal of the American Academy of Child & Adolescent Psychiatry · doi:10.1097/01.chi.0000085756.71002.86 · Cited by 184 · see citing works
Kayumov, L., Brown, G. M., Jindal, R. D., Buttoo, K., & Shapiro, C. M. (2001) · Psychosomatic Medicine · doi:10.1097/00006842-200101000-00005 · Cited by 160 · see citing works
Luthringer, R., Muzet, M., Zisapel, N., & Staner, L. (2009) · International Clinical Psychopharmacology · doi:10.1097/yic.0b013e32832e9b08 · Cited by 136 · see citing works
Wade, A. G., Crawford, G. M., Ford, I., McConnachie, A., Nir, T., Laudon, M., & Zisapel, N. (2010) · Current Medical Research and Opinion · doi:10.1185/03007995.2010.537317 · Cited by 126 · see citing works
Dose finding of melatonin for chronic idiopathic childhood sleep onset insomnia: an RCT
van Geijlswijk, I. M., van der Heijden, K. B., Egberts, T. C. G., Korzilius, H. P. L. M., & Smits, M. G. (2010) · Psychopharmacology · doi:10.1007/s00213-010-1962-0 · Cited by 110 · see citing works
Garzón, C. E. R., Guerrero, J. M., Aramburu, Ó., & Guzmán, T. (2009) · Aging Clinical and Experimental Research · doi:10.1007/bf03324897 · Cited by 99 · see citing works
Ellis, C., Lemmens, G. M. D., & Parkes, J. D. (1996) · Journal of Sleep Research · doi:10.1046/j.1365-2869.1996.00003.x · Cited by 82 · see citing works
Medical comorbidity of sleep disorders
Dikeos, D. G., & Georgantopoulos, G. (2011) · Current Opinion in Psychiatry · doi:10.1097/yco.0b013e3283473375 · Cited by 75 · see citing works
Srinivasan, V., Brzezinski, A., Pandi-Perumal, S. R., Spence, D. W., Cardinali, D. P., & Brown, G. M. (2011) · Progress in Neuro-Psychopharmacology and Biological Psychiatry · doi:10.1016/j.pnpbp.2011.03.013 · Cited by 72 · see citing works
Insomnia Associated with Valerian and Melatonin Usage in the 2002 National Health Interview Survey
Bliwise, D. L., & Ansari, F. P. (2007) · SLEEP · doi:10.1093/sleep/30.7.881 · Cited by 53 · see citing works
Dawson, D. E., Rogers, N. L., van den Heuvel, C. J., Kennaway, D. J., & Lushington, K. (1998) · Journal of Biological Rhythms · doi:10.1177/074873098129000354 · Cited by 53 · see citing works
Psychological and Behavioral Treatments for Primary Insomnia
Morin, C. M. (2005) · Elsevier eBooks · doi:10.1016/b0-72-160797-7/50068-9 · Cited by 52 · see citing works
Insomnia: evidence-based approaches to assessment and management
Morgan, K., Kucharczyk, E., & Gregory, P. (2011) · Clinical Medicine · doi:10.7861/clinmedicine.11-3-278 · Cited by 27 · see citing works
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Baranwal, N., Yu, P. K., & Siegel, N. S. (2023) · Progress in Cardiovascular Diseases · doi:10.1016/j.pcad.2023.02.005 · Cited by 540 · see citing works
Minich, D. M., Henning, M., Darley, C., Fahoum, M., Schuler, C. B., & Frame, J. (2022) · Nutrients · doi:10.3390/nu14193934 · Cited by 176 · see citing works
Zarezadeh, M., Khorshidi, M., Emami, M., Janmohammadi, P., Kord‐Varkaneh, H., Mousavi, S. M., Mohammed, S. H., Saedisomeolia, A., & Alizadeh, S. (2019) · European Journal of Nutrition · doi:10.1007/s00394-019-02123-0 · Cited by 92 · see citing works
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Perez‐Lloret, S., & Cardinali, D. P. (2021) · Frontiers in Pharmacology · doi:10.3389/fphar.2021.650597 · Cited by 64 · see citing works
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Nagendra, R. P., Sathyaprabha, T. N., & Kutty, B. M. (2022) · Sleep Science · doi:10.5935/1984-0063.20220039 · Cited by 12 · see citing works
Etholén, A., Pietiläinen, O. K., Kouvonen, A. M., Hänninen, M., Rahkonen, O., & Lallukka, T. M. (2022) · Journal of Aging and Health · doi:10.1177/08982643221078740 · Cited by 9 · see citing works
Fetouh, A. M., Omara, A. F., & Elzohry, A. A. M. (2020) · Local and Regional Anesthesia · doi:10.2147/lra.s244510 · Cited by 8 · see citing works
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Tucker, R. M., Kim, N.-H., Gurzell, E. A., Mathi, S., Chavva, S., Senthilkumar, D., Bartunek, O., Fenton, K. C., Herndon-Fenton, S. J., Cardino, V. N., et al. (2024) · Nutrients · doi:10.3390/nu16234125 · Cited by 7 · see citing works
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Ratneswaran, C., Sagoo, M. K., & Steier, J. S. (2018) · Journal of Thoracic Disease · doi:10.21037/jtd.2017.10.162 · Cited by 6 · see citing works
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Molina‐Carballo, A., Jerez-Calero, A. E., Fernández-López, L., Augustin-Morales, M. D. C., Muñoz‐Hoyos, A., & Agil, A. (2023) · Melatonin Research · doi:10.32794/mr112500159
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Rana, I., Sharma, N., & ., H. (2024) · International Journal of Research and Review · doi:10.52403/ijrr.20240733
Swami, S. (2024) · Elsevier eBooks · doi:10.1016/b978-0-443-13814-0.00016-8
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- Authors
- Ferracioli-Oda, E., Qawasmi, A., & Bloch, M. H.
- Venue
- Focus
- Published
- 2018-01
- Volume
- 16
- Issue
- 1
- Pages
- 113-118
- ISSN
- 1541-4094 (ISSN-L)
- 1541-4108
- PMC
- PMC6519571
- OpenAlex
- W4242764016
- Cited by
- 18
- References
- 35
- Citations by year
- 2026: 1 · 2024: 7 · 2023: 2 · 2022: 4 · 2021: 1 · 2020: 1 · 2019: 1 · 2018: 1
- FWCI
- 0.56
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- FOCUS The Journal of Lifelong Learning in Psychiatry (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- Topics
- Life Sciences › Neuroscience › Endocrine and Autonomic Systems › Circadian rhythm and melatonin
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and related disorders
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and Work-Related Fatigue
- Keywords
- melatonin, primary sleep disorders, insomnia, sleep latency, total sleep time, sleep quality, treatment duration, placebo comparison
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