Overview of drugs used for insomnia in children

Drug class	Examples	Bottom line
Nonprescription medications
Antihistamines	First-generation drugs – Diphenhydramine, hydroxyzine, chlorpheniramine Second- and third-generation drugs (less sedating) – Fexofenadine and loratadine	Consider for short-term situational and/or occasional use in younger children, especially those with comorbid atopic disease.
Melatonin	Many over-the-counter preparations (eg, tablet, gummy, liquid)	Consider short-term use for children with sleep-onset insomnia, in combination with behavioral interventions. Most empiric evidence is in neurodiverse children (eg, autism). May also be used in patients (typically adolescents) with circadian phase delay.
Prescription insomnia drugs
Benzodiazepines	Triazolam, estazolam, temazepam, lorazepam, flurazepam	Limited utility in pediatric populations; other properties (eg, anxiolytic, muscle relaxant, anticonvulsant, long duration of action) may be useful in some neurodiverse patients.
Nonbenzodiazepine receptor agonists	Eszopiclone, zaleplon, zolpidem	Lack of documented efficacy and significant sleep-related behavior side effects limit utility, except in older adolescents.
Others	Ramelteon (synthetic melatonin receptor agonist) Dual orexin receptor antagonists (survorexant, lemborexant, daridorexant) Doxepin (tricyclic antidepressant; selective histamine receptor agonist)	Ramelteon may be a reasonable choice for mild sleep-onset insomnia, especially with circadian component, but cost and lack of insurance coverage may limit use. Dual orexin receptor antagonism is a novel mechanism for sleep onset and maintenance insomnia. Doxepin is indicated for sleep maintenance insomnia in low doses.
Drugs used off-label for insomnia
Alpha-adrenergic agonists	Clonidine Guanfacine	These agents are commonly prescribed for childhood insomnia. Although there are few data to support this use, clinical experience suggests they are generally effective and well tolerated in ADHD.
Antidepressants	Tricyclic antidepressants with sedating effects – Amitriptyline, doxepin, imipramine Atypical antidepressants – Mirtazapine, trazodone SSRIs with sedating effects – Fluvoxamine, paroxetine, citalopram	Likely most useful in the setting of comorbid mood disorders and/or anxiety; little evidence to support the use of trazodone as drug of choice within this class^*.

Note that none of these drugs are approved by the US Food and Drug Administration (FDA) for this purpose in children. Behavioral approaches to managing insomnia are generally preferable.

ADHD: attention deficit hyperactivity disorder; ASD: autism spectrum disorder; SSRI: selective serotonin reuptake inhibitor.

* The American Academy of Sleep Medicine (AASM) practice guideline suggests against the use of trazodone for sleep-maintenance insomnia in adults with primary insomnia, based on paucity of data and the small effect sizes observed in the single randomized trial^[1].

Reference:

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.

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Overview of drugs used for insomnia in children