0923 Doxepin in Children and Adolescents With Symptoms of Insomnia: A Single Center Experience

Abstract

Abstract Introduction Pediatric insomnia is a widespread problem and especially difficult to manage in children with neurodevelopmental disorders. There are currently no FDA- approved medications for pediatric patients to use once first line therapy fails. Doxepin is FDA-approved at low doses for use in transient or chronic sleep maintenance insomnia in adults. The objective of this study is to determine the tolerability and efficacy of doxepin in the pediatric population. Methods 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. Results Total of 29 patients were included in analysis. Mean follow-up duration was 6.5 months (±3.5). Out of 29 patients, 4 (13.8%) patients discontinued doxepin due to lack of efficacy or side effects. 8 (27.6%) patients showed significant improvement of their insomnia, 8 (27.6%) showed moderate, 10 (34.5%) showed mild and 3 (10.3%) showed minimal to no improvement on treatment with doxepin (P<0.05) Only two patients (6.8%) experienced adverse effects in the form of behavioral side effects (aggression) and enuresis. Conclusion 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 Ausitsm specutrm disorder, other neuro-developmental disorders and attention deficit hyperactivity disorder. It is also an effective, safe, and well-tolerated alternative in children suffering from chronic persistent insomnia. The results of this study suggests a promising emerging therapy for the treatment of insomnia in the pediatric population. Support None