Efficacy and Safety of Non-Pharmacological Therapies for Primary Insomnia: A

Qinhong Zhang¹Yong-jian Liu²Guanhu Yang³Mei-yi Zhu²Jia-hui Yang²Lun Li²Xiu-mei Yan²Qi-lin Liu²Jinhuan Yue⁴Xiao-ling Li⁵Yi-ming Li⁶Tian-cheng Xu⁷Fan Jiang^8*

• ¹Heilongjiang University of Chinese Medicine, Harbin, China
• ²Jiangxi University of Chinese Medicine, Nanchang, China
• ³Research Department, Swiss TCM University, Bad Zurzach, Switzerland
• ⁴Shenzhen Frontiers in Chinese Medicine Research Co., Ltd., Shenzhen, China
• ⁵First Affiliated Hospital of Heilongjiang University of Chinese Medicine, Harbin, China
• ⁶Research Department of Swiss University of Traditional Chinese Medicine, Bad Zurzach, Switzerland
• ⁷Key Laboratory of Acupuncture and Medicine Research of Ministry of Education, Nanjing University of Chinese Medicine, Nanjing, China
• ⁸The Affiliated Hospital of Jiangxi University of Chinese Medicine, Nanchang, China

Background: Primary insomnia (PI) is a prevalent sleep disorder that significantly impacts quality of life. While pharmacological treatments are common, concerns about side effects and dependency have led to increased interest in non-pharmacological alternatives. This study systematically evaluates the efficacy and safety of various non-pharmacological therapies for adult PI through a network meta-analysis, providing evidence-based guidance for clinicians.We analyzed 53 randomized controlled trials (RCTs) involving 4,181 adults with PI. The included studies assessed 11 non-pharmacological interventions, such as acupuncture, acupressure, cupping therapy, and cognitive behavioral therapy (CBT), alongside control groups (e.g., placebo, waitlist, and pharmacological comparators).Primary outcomes included the Pittsburgh Sleep Quality Index (PSQI), total sleep time (TST), sleep efficiency (SE), and sleep latency (SL). Data synthesis was performed using STATA 17 software with a random-effects model, and evidence quality was appraised using the GRADE framework.Results: Pooled analyses revealed that all seven non-pharmacological therapies significantly improved PI outcomes compared to controls. Acupuncture reduced PSQI scores by -2.71 points (95% confidence interval (CI): -4.94 to -0.49) versus waitlist, while acupuncture showed a -1.81 point reduction (95% CI: -2.93 to -0.68). For SE, acupressure and CBT increased SE by 1.48% (95% CI: 0.56-2.39) and 1.34% (95% CI: 0.70-1.98), respectively, compared to SH. Notably, CBT and acupressure shortened SL by approximately 10 minutes (e.g., CBT: -10.15 minutes, 95% CI:-11.79 to -8.52 vs. benzodiazepines), while acupressure extended TST by 2.07 hours (95% CI: 0.46-3.68). SUCRA rankings identified CBT as the most effective for reducing SL (85.8% probability) and improving SE (89.2%), whereas acupuncture excelled in increasing TST (84.8%). Adverse events were infrequent and mild, primarily limited to transient localized reactions in acupuncture studies.This study demonstrates that non-pharmacological therapies are effective and safe in managing PI, with CBT, acupuncture, and acupressure emerging as optimal choices for specific sleep parameters. These findings advocate non-pharmacological interventions into clinical practice and offer clinicians valuable insights for selecting appropriate treatment modalities for PI management. However, study limitations like heterogeneity and small sample sizes highlight the need for larger, well-designed RCTs. Future studies should use standardized measures for more specific insomnia assessment.