Comparative efficacy of two interventions to discontinue long-term benzodiazepine use: cluster randomised controlled trial in primary care
C. Vicens, F. Bejarano, E. Sempere, C. Mateu, F. Fiol, I. Socias, E. Aragonès, V. Palop, J. L. Beltran, J. L. Piñol, G. Lera, S. Folch, M. Mengual, J. Basora, M. Esteva, J. Llobera, M. Roca, M. Gili, A. Leiva
  • Declaration of interest




Benzodiazepines are extensively used in primary care, but their long-term use is associated with adverse health outcomes and dependence.


To analyse the efficacy of two structured interventions in primary care to enable patients to discontinue long-term benzodiazepine use.


A multicentre three-arm cluster randomised controlled trial was conducted, with randomisation at general practitioner level (trial registration ISRCTN13024375). A total of 532 patients taking benzodiazepines for at least 6 months participated. After all patients were included, general practitioners were randomly allocated (1:1:1) to usual care, a structured intervention with follow-up visits (SIF) or a structured intervention with written instructions (SIW). The primary end-point was the last month self-declared benzodiazepine discontinuation confirmed by prescription claims at 12 months.


At 12 months, 76 of 168 (45%) patients in the SIW group and 86 of 191 (45%) in the SIF group had discontinued benzodiazepine use compared with 26 of 173 (15%) in the control group. After adjusting by cluster, the relative risks for benzodiazepine discontinuation were 3.01 (95% CI 2.03-4.46, P<0.0001) in the SIW and 3.00 (95% CI 2.04-4.40, P<0.0001) in the SIF group. The most frequently reported withdrawal symptoms were insomnia, anxiety and irritability.


Both interventions led to significant reductions in long-term benzodiazepine use in patients without severe comorbidity. A structured intervention with a written individualised stepped-dose reduction is less time-consuming and as effective in primary care as a more complex intervention involving follow-up visits.


  • Funding

    The study was funded by the Carlos III Health Institute of the Ministry of Economy and Competitiveness (contract PS09/00947). The Ministry had no role in the design and conduct of the study, the collection, management, analysis or interpretation of the data, and the preparation, review, and approval of the manuscript or in the decision to submit for publication. The research was conducted independently from the funding body.

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