Objectives. To assess the efficacy of Reslip (doxylamine) in acute insomnia in comparison with Donormyl. Materials and methods. A multicenter, open, randomized trial was conducted at six medical centers in the Russian Federation. The trial included 60 patients with acute insomnia aged 30–59 years, who were randomized into two groups. Patients of one group received Reslip and those of the other received Donormyl at the same dose and regime. Results. Most patients in both groups experienced improvements in the clinical signs of acute insomnia. The severity of insomnia, daytime drowsiness, and reductions in quality of sleep in both groups showed highly significant decreases. Side effects from the drugs were rare and in most cases did not require treatment termination. There were no significant differences in treatment results with Reslip and Donormyl. Conclusions. Short-term treatment with doxylamine formulations had marked positive clinical effects in acute insomnia, combined with satisfactory tolerance by the patients. The Russian doxylamine formulation Reslip had clinical efficacy and tolerance which were no different from those of Donormyl and can be used in clinical practice for the treatment of acute insomnia.
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