Pharmacotherapeutic management of sleep disorders in children with neurodevelopmental disorders

Expert Opin Pharmacother. 2019 Dec;20(18):2257-2271. doi: 10.1080/14656566.2019.1674283. Epub 2019 Oct 22.


Introduction: Sleep disturbances are highly prevalent in children with neurodevelopmental disabilities. Without appropriate treatment, sleep disorders can become chronic and last for many years. However, there are no sleep medications approved by the United States Food and Drug Administration and only one has been approved by the European Medicines Agency for pediatric insomnia; thus, most medications are prescribed off-label.Areas covered: In this narrative review, the authors highlight and summarize the most common drugs and supplements used for the treatment of sleep problems in children with neurodevelopmental disabilities. Recommendations are formulated regarding the use of melatonin and melatonin receptor agonists, sedating antidepressants, antipsychotics, antihistamines, gabapentin, clonidine and orexin receptor antagonists, and benzodiazepines and hypnotic benzodiazepine receptor agonists.Expert opinion: The choice of pharmacological agents and their dosage should be individualized taking into consideration multiple factors, including the severity and type of sleep problem and the associated neurological pathology. Melatonin is widely used and safe in children with neurodevelopmental conditions. Gabapentin, clonidine, trazodone, and mirtazapine hold promise but require further study. Supplements (iron, vitamin D, and 5-hydroxytryptophan) might be helpful. Due to the lack of clinical data, there is still uncertainty concerning dosing regimens and tolerability.

Keywords: Sleep disorders; drug effects; insomnia; melatonin; neurodevelopmental disorders.

Publication types

  • Review

MeSH terms

  • Antidepressive Agents / therapeutic use
  • Antipsychotic Agents / therapeutic use
  • Child
  • Dietary Supplements
  • Humans
  • Hypnotics and Sedatives / therapeutic use
  • Melatonin / therapeutic use
  • Neurodevelopmental Disorders / complications
  • Neurodevelopmental Disorders / drug therapy*
  • Sleep / drug effects*
  • Sleep Initiation and Maintenance Disorders / drug therapy
  • Sleep Wake Disorders / drug therapy*


  • Antidepressive Agents
  • Antipsychotic Agents
  • Hypnotics and Sedatives
  • Melatonin