BackgroundInsomnia is a common sleep disorder affecting approximately 10-20% of adults worldwide. Despite various available treatment modalities, significant gaps remain in improving sleep maintenance and reducing functional impairments.ObjectiveTo systematically review and synthesize studies on the efficacy and safety of Dimdazenil for the treatment of insomnia.MethodsA comprehensive search of multiple databases and websites was conducted to identify published and unpublished trials from inception to July 19, 2024. Due to the limited number of studies available, quantitative data were synthesized narratively.ResultsThis synthesis included four randomized controlled trials. The primary efficacy endpoints of these studies met the predetermined criteria for superiority. Dimdazenil significantly improved certain objective and subjective sleep measures in patients with insomnia, including reduced sleep latency and longer total sleep duration. Importantly, these outcomes were achieved without causing significant excessive daytime drowsiness or impairing daytime functionality. Furthermore, Dimdazenil demonstrated a generally acceptable safety profile and was well tolerated. Most evaluation indicators related to withdrawal symptoms, drug residues, and rebound effects did not show significant statistical differences.LimitationsThe number of included studies and sample sizes were small, and there is a lack of data on the long-term efficacy and safety of Dimdazenil.ConclusionsDimdazenil offers significant benefits in improving sleep onset and maintenance in patients with insomnia. It presents a favorable safety and tolerability profile while preserving daytime functioning. Future studies should extend the duration and scale to assess the long-term efficacy and safety of Dimdazenil across diverse populations.