Efficacy of clonidine and melatonin for treating insomnia in anxious children: a randomized comparison

Clonidine and melatonin are two medications that are used off-label in the management of sleep disorders in children. However, there is currently no well-established and effective treatment for sleep disturbances among pediatric patients with anxiety disorders. In this study, 72 children aged 6 to 12 years diagnosed with anxiety disorders and suffering from insomnia who attended the Farshchian Hospital Clinic in Hamadan between October 2022 and July 2023 were enrolled. Participants were randomly assigned, using simple randomization, into three groups of 24 each to receive clonidine, melatonin, or placebo. Sleep quality was assessed using the Children’s Sleep Habits Questionnaire (CSHQ) at baseline, week 4, and week 6. Both participants and investigators were blinded to the treatment allocation. This study registered with the Iranian Clinical Trials Registry (IRCT20220820055756N1, registered October 16, 2022). All 72 participants completed the study. Children receiving clonidine or melatonin showed significant improvement in sleep habits compared with the placebo group at the end of six weeks (P < 0.001). However, there was no significant difference between clonidine and melatonin in terms of sleep quality improvement at week six (P = 0.267). Notably, the incidence of adverse effects did not differ significantly among the three groups. The findings of the present study indicate that both clonidine and melatonin are effective treatments for sleep disturbances in children with anxiety disorders.