Background Acupuncture has demonstrated beneficial effects on sleep outcomes in patients with chronic insomnia disorder (CID); however, robust evidence from randomized controlled trials evaluating its efficacy as an adjunctive intervention to facilitate discontinuation of non-benzodiazepines (NBZDs) remains limited. Objective To evaluate the clinical efficacy and safety of electroacupuncture as an adjunctive therapy for reducing NBZDs use in patients with chronic insomnia disorder. Methods This single-blind, randomized, controlled trial will enroll 78 adults with chronic insomnia disorder (ICSD-3TR) who have used NBZDs for 6 months. Participants will be assigned 1:1 to electroacupuncture or sham electroacupuncture. Both groups will undergo a standardized, gradual NBZDs tapering protocol over 6 weeks and receive standardized sleep hygiene education. Participants in the electroacupuncture group will receive electroacupuncture treatment three times per week at predefined acupoints (Baihui, Sishencong, Anmian, Shenting, Yintang, Hegu, Taichong, Neiguan, Shenmen, Sanyinjiao, Shenmai, and Zhaohai), whereas participants in the control group will receive non-penetrative sham electroacupuncture. The primary outcome is the successful discontinuation rate of NBZDs at the end of the 6-week treatment period. Secondary outcome measures included subjective sleep scales, objective sleep parameters (polysomnography and actigraphy), and daytime functioning assessments, among others. Safety will be assessed through systematic monitoring and documentation of adverse events. Statistical analyses will follow the intention-to-treat principle using mixed-effects models. Conclusion This trial aims to provide high-quality evidence regarding the efficacy and safety of electroacupuncture as an adjunctive intervention for NBZDs tapering in patients with chronic insomnia. The findings may support the integration of a low-risk, non-pharmacological treatment option into clinical practice and address an important gap in current insomnia management strategies. Clinical trial registration https://itmctr.ccebtcm.org.cn/mgt/project/view/1998715224785551360 , ITMCTR2025002446.
Chen et al. (Wed,) studied this question.