A randomized, controlled prospective trial of zolpidem and haloperidol for use as sleeping agents in pediatric burn patients

Children with burn injuries often require hospital treatment where they are subjected to stimuli likely to produce sleep deprivation. Previously demonstrated sleep fragmentation and significantly reduced sleep stage 3/4 and rapid eye movement in this population led to a search for sleep-enhancing interventions. The purpose of this study was to evaluate the effects of selected therapeutic interventions on sleep architecture. Forty patients with a mean (+/- SEM) age of 9.4 +/- 0.7 years, mean total burn surface area of 50.1 +/- 2.9% and full thickness burns of 43.2 +/- 3.6% were randomly assigned to one of two treatment regimens using a blinded crossover design. Continuous polysomnographic recordings were obtained for six study periods. Each patient alternately received zolpidem one week and haloperidol the next, with the first monitored night conducted without medication. Zolpidem minimally increased the proportion of 3/4 and rapid eye movement sleep (0.81 +/- 0.16 vs 0.61 +/- 0.10 hrs, P = .02) but not total sleep time (4.8 +/- 0.3 vs 4.3 +/- 0.3 hrs on control nights, P =.1). Haloperidol significantly increased total sleep (5.3 +/- 0.3 vs 4.3 +/- 0.3 hrs on control nights, P = .02) and stage 2 sleep (3.3 +/- 0.3 vs 2.4 +/- 0.2 hrs, P =.001) compared with control nights. Both drugs slightly improved average sleep and wake period duration compared with control nights. Although sleep was somewhat improved by each test drug, there were no statistically significant differences between the drugs. Additional studies are needed to identify methods for improving restorative sleep postburn.