Objective. To obtain further evidence of the efficacy of dormikind in infant/young children. Material and methods. The study was performed in the group of 114 patients, aged 6 months to 2.5 years, with sleep and sleep initiation disorders. Sixty-four patients received treatment with dormikind (group 1) and 50 patients received behavioral therapy (group 2) for 28 days. Results and conclusion. In group 1, sleep initiation decreased by 1.7 times and reached 26.2±4.8 minutes, the number of children sleeping on hands dropped by 8.7 times and sleeping in the parent’s bed by 2 times. In group 2, the same characteristics changed by 1.1, 1.3 and 1.5 times, respectively, and sleep initiation reached 33.4±2.9 minutes. The number of patients of group 1 falling asleep in their own beds increased by 3.2 times vs 1.2 times in group 2. Duration of night sleep increased and frequency of awakening reduced as well. The significant positive dynamics was noted in the emotional-behavior state of children after therapy: the total score significantly improved by 2.9 times to the end of treatment compared to group 2 (by 1.3 times). IMOS score showed significant difference between the groups on «total recovery» and «significant improvement». Therefore, the high efficacy and safety of dormikind in children have been confirmed.