Document Type : original article


1 Children Growth Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Qazvin, Iran. 2 Department of Pediatrics, School of Medicine, Qazvin University of Medical Sciences,


Background: Melatonin is effective as a treatment option for sleep disorders in children. Parents can develop positive sleep habits in children through behavior therapy. This study aimed to evaluate the effects of melatonin on children undergoing behavioral therapy.
Method: The present study was performed on 60 children (1–3-year-old, male and female). Thirty children were randomly selected as the treatment group, treated with melatonin. All of the participants in both treatment and control groups and their parents were taught how to observe sleep hygiene and behavior therapy through a graduated extinction method. The Pediatric Sleep Clinic Questionnaire Background Information (for 1–3-year-old children) was used in this research. Parents in both groups were educated on sleep hygiene and behavioral therapy. The data was analyzed through paired t-test and chi-square (p < 0.05) using SPSS 18 software program.
Result: Mean ± SD (standard deviation) of age was 27.33 ± 8.99 months in the behavior therapy/melatonin-treated group, while it was 23.10 ± 10.76 months in the behavior therapy/non-melatonin-treated group. There was a significant difference between the two groups regarding breastfeeding (p <0.05). Moreover, significant differences were observed between the two groups in terms of the average number of waking ups during the night, the length of wakefulness of a child at night (in minutes), the time of waking up in the morning, the average sleep time at night (in hours), and the relationship between sleeping in parents’ bed and parents staying in the child’s room after the lights were switched off (p <0.05).
Conclusion: The quality of night sleep in the melatonin-treated group was better than that in the group that did not receive melatonin. Therefore, proper medical treatment along with psychological and behavioral therapies can be helpful for treating sleep disorders


  1. Chaput JP, Gray CE, Poitras VJ, Carson V, Gruber R, Birken CS, MacLean JE, Aubert S, Sampson M, Tremblay MS. Systematic review of the relationships between sleep duration and health indicators in the early years (0-4 years). BMC Public Health 2017; 17:855.
  2. Sateia MJ. International classification of sleep disorders-third edition: highlights and modifications. Chest 2014; 146:1387-1394.
  3. Hill CM, Everitt H. Assessment and initial management of suspected behavioral insomnia in pre-adolescent children. BMJ 2018; 363:k3797.
  4. Plante DT, Epstein LJ, Fields BG, Shelgikar AV, Rosen IM. Competency-based sleep medicine fellowships: addressing workforce needs and enhancing educational quality. J Clin Sleep Med 2020 15; 16(1):137-141.
  5. Barion A, Zee PC. A clinical approach to circadian rhythm sleep disorders. Sleep Med 2007 Sep; 8(6):566-577.
  6. Dodge NN, Wilson GA. Melatonin for treatment of sleep disorders in children with developmental disabilities. J Child Neurol 2001; 16(8):581-584.
  7. van Maanen A, Meijer AM, Smits MG, Oort FJ. Termination of short term melatonin treatment in children with delayed Dim Light Melatonin Onset: effects on sleep, health, behavior problems, and parenting stress. Sleep Med 2011; 12(9):875-879.
  8. Miyamoto A, Fukuda I, Tanaka H, Oka R, Araki A, Cho K. Treatment with ramelteon for sleep disturbance in severely disabled children and young adults. No To Hattatsu 2013; 45(6):440-444.
  9. Smits MG, van Stel HF, van der Heijden K, Meijer AM, Coenen AM, Kerkhof GA. Melatonin improves health status and sleep in children with idiopathic chronic sleep-onset insomnia: a randomized placebo-controlled trial. J Am Acad Child Adolesc Psychiatry 2003; 42(11):1286-1293.
  10. Kang EK, Kim SS. Behavioral insomnia in infants and young children. Clin Exp Pediatr 2021; 64(3):111-116.
  11. Esposito S, Laino D, D'Alonzo R, Mencarelli A, Di Genova L, Fattorusso A, Argentiero A, Mencaroni E. Pediatric sleep disturbances and treatment with melatonin. J Transl Med 2019 12; 17(1):77.
  12. Al Twaijri WA, Ba Armah D, Bin Sabbar N, Aldebasi T, Shaheen N, Al Bekairy AKS, Al-Jeraisy M. Effect of melatonin in children with neurodevelopmental disabilities and sleep disorders. J Family Med Prim Care 2022; 11(1):299-304.
  13. Lewien C, Genuneit J, Meigen C, Kiess W, Poulain T. Sleep-related difficulties in healthy children and adolescents. BMC Pediatr 2021; 21(1):82.
  14. Shoghy M, Khanjari S, Farmani F, Hosseini F. Sleep habits of school age children. IJN 2005; 18(41-42):131-138 (Persian).
  15. Touchette E, Petit D, Paquet J, Boivin M, Japel C, Tremblay RE, Montplaisir JY. Factors associated with fragmented sleep at night across early childhood. Arch Pediatr Adolesc Med 2005; 159(3):242-249.
  16. El Rafihi-Ferreira R, Pires MLN, de Mattos Silvares EF. Behavioral intervention for sleep problems in childhood: a Brazilian randomized controlled trial. Psicol Reflex Crit 2019 28; 32(1):5.
  17. Waldron AY, Spark MJ, Dennis CM. The use of melatonin by children: parents' perspectives. J Clin Sleep Med 2016; 12(10):1395-1401.
  18. Yan T, Goldman RD. Melatonin for children with autism spectrum disorder. Can Fam Physician 2020; 66(3):183-185.
  19. Tikotzky L, Sadeh A. The role of cognitive-behavioral therapy in behavioral childhood insomnia. Sleep Med 2010; 11(7):686-691.
  20. Khodabakhsh Pirkalani, R., Rahim Jamarouni, H. Effectiveness of mixed cognitive-behavioral therapy and mindfulness-based stress reduction in treating a case of generalized anxiety disorder. Clinical Psychology Studies 2013; 4(13):121-147.