Pediatric insomnia is a widespread problem and especially difficult to manage in children with neurodevelopmental disorders. There are currently no FDA- approved medications to use once first line therapy fails. The objective of this study was to evaluate the efficacy and safety of doxepin in pediatric patients.

Approximately 20% to 30% of infants and toddlers and up to 5% of school-aged children are affected by behavioral insomnia of childhood. Doxepin is FDA-approved at low doses for use in transient or chronic sleep maintenance insomnia in adults. To our knowledge, there are currently no clinical trials and limited data available regarding its use in pediatric insomnia. 

This is a retrospective single center chart review of children and adolescents (2-17 years of age) whose sleep failed to improve with behavioral intervention and melatonin who were then trialed on doxepin. Treatment was initiated at a median starting dose of 2mg and slowly escalated to a median maintenance dose of 10mg. Improvement in sleep was recorded using a 4-point Likert scale reported by parents on follow up visits.

Total of 37 patients were included in analysis. Mean follow-up duration was 6.32 months (SD ±3.5). Out of 37 patients, 4 (10.8%) patients discontinued doxepin due to lack of efficacy or side effects. 12 (32.4%) patients showed significant improvement in insomnia, 12 (32.4%) showed moderate, 10 (27%) showed mild and 3 (8.1%) showed minimal to no improvement on treatment with Doxepin.  Only two patients (5.4%) experienced non life-threatening mild adverse effects. 

Our data suggests that doxepin is effective, safe and well-tolerated in the treatment of sleep initiation and maintenance insomnia as well as psychophysiological insomnia in child and adolescents with autism spectrum disorder and attention deficit hyperactivity disorder. It is also an effective, safe, and well-tolerated alternative in healthy children suffering from chronic persistent insomnia.