Efficacy and safety of midazolam in the treatment of night terrors in children.

Midazolam, in an oral dose of 15 mg, and placebo were administered to 15 children aged 6-15 years in treatment of night terrors. After an initial adaptation night, the patients received placebo for 2 nights, followed by 15 mg midazolam for 2 nights and placebo again on the final 2 nights. Eight-hour nocturnal polygraphic recordings were made after the administration of both placebo and midazolam. The patients were continuously monitored by means of closed circuit infra-red television. Ten of the patients manifested simple episodes while five had attacks associated with motor automatisms and EEG anomalies. The total sleep time was lengthened by midazolam in most of the children; sleep architecture was favourably modified, mainly in terms of the amount and proportion of REM sleep (accompanied by dreams) and stage 2 sleep. Night terrors were eliminated by midazolam in all except one patient. REM sleep latency also decreased as did the number of nocturnal arousals (clinical and/or EEG). In the five cases with a background of organic cerebral disorders, the EEG anomalies and these attacks were suppressed by midazolam especially during the first sleep cycles. Patients' subjective assessment of the quality of sleep was favourable. Midazolam was well tolerated with no side-effects.

RCT Entities:   Population Interventions Outcomes