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Pharmacotherapy for insomnia in children and adolescents: A rational approach

Judith A Owens, MD, MPH
Section Editor
Ronald D Chervin, MD, MS
Deputy Editor
Alison G Hoppin, MD


A variety of behavioral and medical problems can present with childhood insomnia, typically manifested as bedtime resistance, difficulty initiating sleep, night wakings, or combinations of these symptoms. As a result, it is imperative that the choice of therapy be diagnostically driven as well as developmentally appropriate.

The vast majority of sleep disturbances in children and adolescents are appropriately managed with behavioral therapy alone, and behavioral interventions should be considered first-line therapy, as has been recommended for adults [1]. However, in a limited number of clinical situations, pharmacologic intervention may be appropriate for management of the child or adolescent with significant difficulties in initiating or maintaining sleep, as long as a number of important caveats are taken into consideration.

In practice, a variety of nonprescription (over-the-counter) and prescription medications are used to treat pediatric insomnia by pediatric health care practitioners, or are initiated by a child's parents, often without medical guidance. However, little empirical evidence exists regarding the efficacy, safety, and tolerability of these medications in the pediatric population. Furthermore, no hypnotics or other medications are approved by the Food and Drug Administration (FDA) for treatment of insomnia in children under the age of 16 years. Therefore, pharmacotherapy for insomnia in children is always an off-label use and should be approached with careful evaluation of the potential benefits, risks, and treatment options for the individual patient.

A general approach to making decisions about pharmacotherapy for sleep in children is outlined below, followed by a brief summary of the main considerations for individual medications. Related information is included in other UpToDate topics:

(See "Assessment of sleep disorders in children".)

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Literature review current through: Nov 2017. | This topic last updated: Jun 22, 2017.
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  1. Qaseem A, Kansagara D, Forciea MA, et al. Management of Chronic Insomnia Disorder in Adults: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med 2016; 165:125.
  2. Sriskanda H, Lepore N, Miller M, et al. Caregiver attitudes and usage of sleep-promoting medication in children. Canadian Paediatric Society 2015; 99101.
  3. Owens JA, Rosen CL, Mindell JA. Medication use in the treatment of pediatric insomnia: results of a survey of community-based pediatricians. Pediatrics 2003; 111:e628.
  4. Furster C, Hallerbäck MU. The use of melatonin in Swedish children and adolescents--a register-based study according to age, gender, and medication of ADHD. Eur J Clin Pharmacol 2015; 71:877.
  5. Blumer JL, Findling RL, Shih WJ, et al. Controlled clinical trial of zolpidem for the treatment of insomnia associated with attention-deficit/ hyperactivity disorder in children 6 to 17 years of age. Pediatrics 2009; 123:e770.
  6. Russo RM, Gururaj VJ, Allen JE. The effectiveness of diphenhydramine HCI in pediatric sleep disorders. J Clin Pharmacol 1976; 16:284.
  7. Merenstein D, Diener-West M, Halbower AC, et al. The trial of infant response to diphenhydramine: the TIRED study--a randomized, controlled, patient-oriented trial. Arch Pediatr Adolesc Med 2006; 160:707.
  8. Sateia MJ, Buysse DJ, Krystal AD, et al. Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: An American Academy of Sleep Medicine Clinical Practice Guideline. J Clin Sleep Med 2017; 13:307.
  9. Walsh JK, Erman M, Erwin CW, et al. Subjective hypnotic efficacy of trazadone and zolpidem in DSM-III-R primary insomnia. Hum Psychopharmacol 1998; 13:191.
  10. van Geijlswijk IM, Korzilius HP, Smits MG. The use of exogenous melatonin in delayed sleep phase disorder: a meta-analysis. Sleep 2010; 33:1605.
  11. Bruni O, Alonso-Alconada D, Besag F, et al. Current role of melatonin in pediatric neurology: clinical recommendations. Eur J Paediatr Neurol 2015; 19:122.
  12. Erland LA, Saxena PK. Melatonin Natural Health Products and Supplements: Presence of Serotonin and Significant Variability of Melatonin Content. J Clin Sleep Med 2017; 13:275.
  13. Sangal RB, Blumer JL, Lankford DA, et al. Eszopiclone for insomnia associated with attention-deficit/hyperactivity disorder. Pediatrics 2014; 134:e1095.
  14. Prince JB, Wilens TE, Biederman J, et al. Clonidine for sleep disturbances associated with attention-deficit hyperactivity disorder: a systematic chart review of 62 cases. J Am Acad Child Adolesc Psychiatry 1996; 35:599.
  15. Rugino TA. Effect on Primary Sleep Disorders When Children With ADHD Are Administered Guanfacine Extended Release. J Atten Disord 2018; 22:14.
  16. Mendelson WB. A review of the evidence for the efficacy and safety of trazodone in insomnia. J Clin Psychiatry 2005; 66:469.
  17. Kem DL, Posey DJ, McDougle CJ. Priapism associated with trazodone in an adolescent with autism. J Am Acad Child Adolesc Psychiatry 2002; 41:758.
  18. Shamseddeen W, Clarke G, Keller MB, et al. Adjunctive sleep medications and depression outcome in the treatment of serotonin-selective reuptake inhibitor resistant depression in adolescents study. J Child Adolesc Psychopharmacol 2012; 22:29.
  19. NIH State-of-the-Science Conference Statement on manifestations and management of chronic insomnia in adults. NIH Consens State Sci Statements 2005; 22:1.