The efficacy of low and moderate dosage of diazepam on sleep bruxism in children: A randomized placebo-controlled clinical trial

Background: Sleep bruxism (SB) in children is commonly a self‑limited problem; however, therapy of the condition may be needed to improve sleep quality of parents and children. Benzodiazepines have some success in controlling adult bruxism. The objective of this study was to evaluate the effect and the safety of a short course of diazepam on controlling SB in healthy children. Materials and Methods: In this double‑blind, randomized placebo‑controlled clinical trial, 109 children with SB were randomly assigned to three groups, receiving low or moderate dose of diazepam or placebo for 2 weeks. For children aged 2–8 years, the dose of 2.5 and 5 mg was considered as low and moderate dose consequently. In children 8 years, the doses were doubled. The severity of SB was evaluated at the beginning and also 2, 8, and 12 weeks thereafter. Data were collected by a questionnaire completed by parents including frequency of SB per week and per night and duration of each SB, as bruxism severity score (BSS). A mixed‑model ANOVA was used to assess the differences of mean BSS between different groups and measurement times. Results: From 109 children recruited, 90 completed the study. After 2 weeks of intervention, the mean BSS decreased significantly in all groups (P = 0.0001), but it was not significantly different between groups in any of follow‑ups (P = 0.554). Next‑day sleepiness was assessed at week 2 of the study and was significantly higher in the groups using diazepam (P = 0.026). Conclusion: Short course of diazepam was not more effective than placebo for long‑term control of SB in children.