Acupuncture combined with gradual benzodiazepine reduction for benzodiazepine-dependent Insomnia: A multicenter randomized controlled trial

Background: This study aimed to evaluate the clinical efficacy of acupuncture combined with gradual benzodiazepine dose reduction in patients with benzodiazepine-dependent insomnia (BDI) and to assess associated withdrawal outcomes. Methods: A total of 64 patients with BDI were randomly assigned to either the acupuncture plus gradual benzodiazepine reduction group (ARB, n = 32) or the placebo acupuncture plus gradual benzodiazepine reduction group (PARB, n = 32). Treatments were administered five times per week for 4 weeks, followed by an 8-week observation period. The primary outcomes were changes in Insomnia Severity Index (ISI) scores and the drug reduction rate of benzodiazepines (DRRB). Secondary outcomes included the rate of successful discontinuation and scores on the Fatigue Scale-14 (FS-14). Results: Sixty-three patients completed the trial (ARB group, n = 32; PARB group, n = 31). Patients in the ARB group demonstrated significantly greater reductions in ISI scores compared with those in the PARB group (p = 0.005 for week 4–week 0 and week 12–week 0 comparisons). The DRRB was also significantly higher in the ARB group compared with the PARB group (p = 0.002 for week 4–week 1 and p < 0.001 for week 12–week 1). At week 12, the ARB group additionally demonstrated lower FS-14 scores and a higher rate of successful benzodiazepine discontinuation. Conclusions: Acupuncture combined with gradual benzodiazepine reduction significantly reduced insomnia severity and promoted benzodiazepine discontinuation in patients with BDI. © 2026 Elsevier Inc. All rights are reserved, including those for text and data mining, AI training, and similar technologies.