Insomnia is a highly prevalent sleep disorder in clinical practice that severely impairs patients' daytime function and quality of life, and there are still unmet medical needs in its clinical treatment. Traditional Chinese medicine (TCM) has unique advantages in the treatment of insomnia, such as holistic regulation, mild adverse reactions, and long-lasting efficacy.In February 2026, the Center for Drug Evaluation of the National Medical Products Administration issued the Guiding Principles for Clinical Trials of Therapeutic Drugs for Chronic Insomnia (for Trial Implementation). However, it lacks targeted and specific regulatory guidance for the clinical trial design of innovative traditional Chinese medicines. Traditional Chinese medicines exert therapeutic effects on insomnia through multiple targets and pathways, which is significantly different from the clinical trial design of chemical drugs. Based on the clinical advantages and characteristics of TCM in the treatment of insomnia, combined with Chinese and Western medicine guidelines for insomnia, technical requirements for TCM clinical trials, and relevant research progress, this paper systematically analyzes key elements including trial background, diagnostic criteria, inclusion and exclusion criteria, run-in period and treatment course design, background therapy and concomitant medication, efficacy and safety indicators, control group selection, statistical analysis, and benefit-risk, and clarifies the design principles, implementation points, and precautions for each key element in the clinical trials of innovative TCM for insomnia, proposes scientific and rational clinical trial design strategies for innovative TCM in the treatment of insomnia, provides a reference for the standardized conduct of such clinical trials, and supports the establishment of high-quality TCM evidence-based evidence and the research, development and promotion of innovative traditional Chinese medicines.

innovative traditional Chinese medicine  /  insomnia  /  clinical trial  /  trial design  /  efficacy indicators  /  safety evaluation