Approximately 20 to 40 percent of parents report frustration because their infants have poor sleeping habits. Even though this is a common problem, there are few studies that evaluate intervention strategies. One option includes using medication to help infants sleep; diphenhydramine (Benadryl), the most commonly used agent, has not been studied in children younger than two years. Even with the lack of science-based evidence, almost one half of the pediatricians surveyed recommend this as an option to the parents of infants with sleep problems. Merenstein and associates evaluated the use of diphenhydramine in infants with parent-reported nighttime awakening.

The trial was a double-blinded, randomized controlled study of the use of diphenhydramine in infants with nighttime awakening. Only children between six and 15 months of age sleeping in a crib and awakening two or more times during the night were included. The children were observed for seven days before receiving the intervention, then they were randomized to receive diphenhydramine (1 mg per kg) or placebo 30 minutes before bedtime.

The main outcome measures included parent-reported improvements in nighttime awakenings, a decrease in the need for parental intervention during the study, a sleep diary evaluation, and parental satisfaction with their children’s sleep habits. Complete evaluations were done at days 15, 29, and 43 of the study.

Approximately one year after the study was initiated, the safety monitoring board stopped the trial because diphenhydramine was no more effective than placebo. There were 22 children enrolled in the diphenhydramine arm, and only one showed any improvement in sleep habits, compared with three out of 22 in the placebo arm. The results for the outcome measurements were similar at days 15, 29, and 43. There were no adverse reactions in either group that caused parents to stop using the treatment. One child in each trial arm reported mild hyperactivity.

The authors conclude that diphenhydramine is no more effective than placebo for improving sleep habits in infants. They add that it is not shown to provide any improvement in parental satisfaction with their children’s sleep patterns. The authors encourage further research into various aspects of young children’s sleep habits so that physicians will be able to make recommendations to parents using evidence-based information.