Unintentional trazodone overdoses in children ≤6 years of age: data from poison center over a period of 16 years.

Context: Trazodone is an atypical antidepressant with no established safety in children. Previous case reports showed no complications at doses 50-500 mg in children. Our study objective is to characterize the clinical effects, dose-related toxicity, and establish triage dose for acute trazodone ingestions in children ≤6 years of age.

Methods: Cases with acute trazodone ingestions in children ≤6 years of age between 2000 and 2015 were retrospectively reviewed. Data were analyzed for dose (mg/kg), clinical effects, management site, treatment, and outcome. Cases with coingestions, unknown outcome, or unknown dose were excluded.

Results: A total of 84 patients (mean age 26.7 months, 35 females, 49 males) were included. Of those, 52 (61.9%) had no clinical effects; 29 (34.5%) had minor effects (vomiting, dizziness, headache); and three (3.6%) had moderate effects (ataxia, slurred speech, priapism). No major effects or deaths were observed. Moderate effects were manifested at doses ≥6.9 mg/kg. Priapism occurred in a 2-year-old child at a dose of 6.9 mg/kg. Sixteen (19%) patients were managed at home and 68 (81%) patients were referred to a HCF. Among those referred to a HCF, three (4.4%) patients had moderate effects with ingested dose ≥6.9 mg/kg. However, 27 (39.7%) patients of those referred to a HCF had an ingested dose <6 mg/kg and none of them manifested symptoms beyond minor effects. All referred patients had uneventful recovery and no sequela.

Conclusions: Children should be referred for further evaluation in acute unintentional trazodone ingestions with doses ≥6 mg/kg.