A randomized pediatric trial did not find diazepam superior to placebo for reported sleep bruxism. Improvement within a treated group therefore could not establish drug efficacy.
Mostafavi and colleagues randomized 109 children to low-dose diazepam, moderate-dose diazepam, or placebo for two weeks. Ninety completed follow-up. Parents reported frequency and duration of bruxism, producing a severity score measured over twelve weeks.
Scores improved initially in all groups, but the groups did not differ significantly across follow-up. Next-day sleepiness was more common with diazepam.
A before-and-after improvement may reflect natural fluctuation, reporting, expectation, or other time-related factors. The placebo group provides a direct check against attributing every change to medication. The study’s nonsignificant comparison does not prove zero possible effect, but did not establish superiority.
The endpoint relied on parental reports rather than repeated objective sleep recordings. Attrition and a short treatment period further limit conclusions about sustained benefit and uncommon adverse effects.
Do not turn better sleep reports after a prescription into proof that the underlying movement disorder responded. This trial separates symptom reports from comparative efficacy and identifies sedation as an unwanted effect that can occur without demonstrated bruxism benefit.
Original analysis of the supplied journal article, identified as PMC6383339.