Abstract Introduction Sleep disorders are a common issue in children, with pediatric insomnia an underrecognized and undertreated problem affecting children. Beyond melatonin and behavioral interventions, there are few options known to clinicians that have been studied for use in pediatric insomnia. The objective of this study is to assess the efficacy, tolerability and safety of doxepin and mirtazapine in pediatric insomnia. Methods This is a retrospective single-center chart review of children less than 18 years of age at the time of treatment initiation who have previously failed behavioral intervention and melatonin, who were then treated with doxepin and/or mirtazapine. Patients were started on doxepin maintenance treatments ranging from 2-10mg and/or mirtazapine, which ranged from 1.875- 15mg. Improvement in sleep was assessed on follow up visits and recorded using a 4-point Likert scale. Results There were 318 pediatric patients included for analysis. We identified 183 patients on doxepin, 24 patients on mirtazapine, and 19 patients who were on dual doxepin-mirtazapine. In the doxepin group, 167 patients (91.26%) experienced improvement in insomnia symptoms. In the mirtazapine group, 16 patients (66.67%) experienced improvement in insomnia symptoms. In the doxepin-mirtazapine group, 13 patients (68.42%) experienced improvement in insomnia symptoms. Thirty-two patients (10%) and three patients (7%) who took doxepin and mirtazapine, respectively experienced adverse effects, most commonly aggression/irritability. Conclusion We found both doxepin and mirtazapine as effective and tolerable treatment options in improving subjective sleep onset and maintenance issues in children with insomnia. Support (if any)
Palladino et al. (Fri,) studied this question.