ⅷ Objective To assess the efficacy of treatment of settling problems and night waking in young children. ⅷ Design A systematic review of randomized controlled trials of interventions. ⅷ Setting Electronic bibliographic databases and references on identified papers, hand searches, and personal contact with specialists. ⅷ Subjects Children aged 5 years or younger who had established settling problems or night waking. ⅷ Interventions Interventions had to be described and a placebo, waiting list, or another intervention needed to have been used as a comparison. Interventions comprised drug trials or nondrug trials. ⅷ Main outcome measures Number of wakes at night, time to settle, or number of nights in which these problems occurred. ⅷ Results Drugs seemed to be effective in treating night waking in the short term, but long-term efficacy was questionable. In contrast, specific behavioral interventions showed both short-term efficacy and possible longer term effects for dealing with settling problems and night waking. ⅷ Conclusions Given the prevalence and persistence of childhood sleep problems and the effects they can have on children and families, treatments that offer long-lasting benefits are more appealing, and these are likely to be behavioral interventions.