失眠症是临床高发的睡眠障碍性疾病，严重影响患者日间功能与生活质量，目前临床治疗仍存在未被满足的需求。中医药治疗失眠症具有整体调理、不良反应少、疗效持久等独特优势。2026年2月，国家药监局审评中心发布了《慢性失眠治疗药物临床试验技术指导原则（试行）》，但其对创新中药临床试验设计尚缺乏针对性和具体性的规范指引。中药治疗失眠具有多靶点、多途径的特点，与化学药物临床试验设计存在显著差异，结合中医药治疗失眠症的临床优势和特点，以及失眠症的中西医指南、中药临床试验技术要求及相关研究进展，从试验背景、诊断标准、纳入和排除标准、导入期与疗程设计、背景治疗与合并用药、疗效与安全性指标、对照组选择、统计分析及获益风险评估等核心要素进行系统分析，明确创新中药治疗失眠症各要素的设计原则、实施要点与注意事项，为创新中药治疗失眠症提出科学合理的临床试验设计思路，为创新中药治疗失眠症的临床试验规范化开展提供参考，助力高质量中医药循证证据的构建与创新中药的研发推广。

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.

R285.64

现代中药新质生产力科技创新工程专项项目（24ZXZKSY00030-08）