Highlights
- The electronically delivered EMPOWER (EMPOWER-ED) protocol achieved a five-fold increase in the likelihood of complete benzodiazepine cessation compared to treatment as usual.
- The intervention demonstrated clinical safety, with no statistically significant increase in anxiety symptoms or sleep disturbances during the tapering process.
- Digital delivery offers a scalable, low-cost solution to the clinical challenge of primary care time constraints in managing complex medication tapering.
The Clinical Burden of Chronic Benzodiazepine Use
Benzodiazepines remain among the most frequently prescribed classes of medications in the United States, with more than 30 million individuals utilizing them for various indications, including anxiety and insomnia. While effective for short-term symptomatic relief, long-term use is associated with significant iatrogenic risks, particularly in older populations. These risks include cognitive impairment, increased frequency of falls and fractures, and the development of substance use disorders. Despite clinical guidelines recommending against long-term use, many patients remain on these medications for years, often due to a phenomenon known as therapeutic inertia or the perceived difficulty of the tapering process.
The primary barrier to tapering is often the intensive clinician time required to educate patients, monitor withdrawal symptoms, and adjust dosages. To address this, researchers previously developed the Eliminating Medications Through Patient Ownership of End Results (EMPOWER) intervention. The original trial utilized printed educational materials to empower patients to initiate tapering. However, in an increasingly digital healthcare landscape, the need for a scalable, electronic version became evident. The EMPOWER-ED trial was designed to evaluate whether this intervention, when delivered via smartphone or computer, could replicate the success of its paper-based predecessor.
Study Design and Methodology
The EMPOWER-ED trial was a 2-arm, individually randomized clinical trial conducted across two Veterans Affairs (VA) health care systems. The study recruited 161 primary care patients who had been using benzodiazepines for at least three months and had access to digital devices (smartphones, tablets, or desktops). Participants were randomized into two groups: the EMPOWER-ED intervention group and a treatment-as-usual (TAU) control group.
The EMPOWER-ED intervention consisted of an electronic protocol designed to provide patients with the rationale for tapering, educational content on the risks of long-term use, and a structured, self-managed tapering schedule. Crucially, the intervention focused on patient autonomy and self-efficacy. The control group continued to follow standard clinician recommendations. The primary endpoints, assessed at a 6-month follow-up using pharmacy records, were complete benzodiazepine cessation and a dose reduction of at least 25%.
Key Findings: Efficacy of Digital Deprescribing
The results of the EMPOWER-ED trial provide robust evidence for the efficacy of digital self-management tools in medication tapering. Analysis was performed on an intent-to-treat basis to ensure the validity of the findings within a real-world clinical context.
Complete Cessation and Dose Reduction
The most striking result was the rate of complete benzodiazepine cessation. Individuals assigned to the EMPOWER-ED group were significantly more likely to achieve total cessation than those in the control group. The calculated odds ratio (OR) was 5.31 (95% CI, 1.12-25.12), indicating a more than five-fold increase in the likelihood of stopping the medication entirely. Interestingly, while the intervention group also showed a higher likelihood of achieving at least a 25% dose reduction (OR, 2.51; 95% CI, 0.91-6.90), this specific metric did not reach statistical significance, suggesting that the intervention is particularly effective at driving patients toward complete discontinuation rather than just moderate reduction.
Secondary Outcomes and Safety Profile
A common concern among clinicians when initiating a benzodiazepine taper is the potential for rebound insomnia or increased anxiety. The EMPOWER-ED trial monitored these secondary outcomes closely. Importantly, there were no statistically significant differences between the intervention and control groups regarding self-reported anxiety symptoms, sleep quality, or overall quality of life. This suggests that the self-managed tapering schedule provided by EMPOWER-ED allows patients to reduce their medication load without experiencing a significant deterioration in their primary symptoms or overall well-being.
Expert Commentary: Implementation and Scalability
The EMPOWER-ED trial addresses a critical gap in translational medicine: the move from evidence-based protocols to scalable public health interventions. By converting a proven paper-based intervention into a digital format, the researchers have created a tool that can be integrated into patient portals and electronic health record (EHR) systems with minimal marginal cost.
From a health policy perspective, the intervention is particularly attractive because it is in the public domain. This allows health systems—including the VA and private providers—to disseminate the tool widely without the licensing fees often associated with proprietary digital health platforms. Furthermore, the reliance on pharmacy data for the primary outcome adds a layer of objective verification to the study’s findings, increasing confidence in the reported cessation rates.
However, some limitations must be considered. The study population was predominantly male, reflecting the VA demographic, which may limit the generalizability of the findings to female populations. Additionally, while the odds ratio for cessation was high, the wide confidence interval suggests a need for larger-scale replication to more precisely estimate the effect size. Future research should also investigate the long-term sustainability of cessation beyond the 6-month mark.
Conclusion
The EMPOWER-ED trial demonstrates that a low-cost, electronically delivered intervention can significantly facilitate benzodiazepine cessation in long-term users. By empowering patients with the knowledge and tools to manage their own tapering process, the intervention bypasses traditional barriers such as clinician time constraints and patient hesitation. As health systems continue to seek ways to improve medication safety and reduce the burden of benzodiazepine dependence, the dissemination of electronic, patient-facing tools like EMPOWER-ED should be considered a priority.
Funding and Trial Registration
This study was supported by the Veterans Health Administration. Trial Registration: ClinicalTrials.gov Identifier: NCT04572750.
References
- Humphreys K, Hagedorn H, Han X, Kemp L, Poitra N, Cucciare MA. Electronic Intervention for Patient-Managed Benzodiazepine Tapering: A Randomized Clinical Trial. JAMA Netw Open. 2026;9(1):e2551807.
- Tannenbaum C, Martin P, Rochefort CM, Eguale T. Reduction of inappropriate benzodiazepine use in community-dwelling older adults: the EMPOWER cluster randomized trial. JAMA Intern Med. 2014;174(6):890-898.
- Maust DT, Lin LA, Blow FC. Benzodiazepine Use and Risk of Incident Dementia or Cognitive Decline: Narrative Review of Observational Studies. J Gen Intern Med. 2019;34(1):97-106.