Pregabalin for the discontinuation of long-term benzodiazepines use: an assessment of its effectiveness in daily clinical practice
Open accessAbstract
PURPOSE: To evaluate the effectiveness and tolerability of pregabalin in the management of the discontinuation of benzodiazepines in long-term users. SUBJECTS AND METHODS: We performed a 12-week, prospective, uncontrolled, non-interventional, and observational study in patients aged 18 years old or above, who met DSM-IV-TR criteria for benzodiazepine dependence without other major psychiatry disorder. Evaluations included the Benzodiazepine Withdrawal Symptom Questionnaire, the Hamilton Anxiety Rating Scale, the Clinical Global Impression Scale, and the Sheehan Disability Scale. A urine drug screen for benzodiazepines was performed at baseline and every 4 weeks thereafter. The primary effectiveness variable was success rate, defined as achievement of benzodiazepine-free status at week 12 according to the urine drug screen. RESULTS AND DISCUSSION: The mean dose at week 12 was 315 (±166) mg/day. The success rate of the benzodiazepine taper in the primary efficacy population (n=282) was 52% (95% confidence interval [CI], 46-58). Success rates for women and men were 58% (95% CI, 49-67) and 46% (95% CI, 38-55), respectively. The success rates did not differ according to either the benzodiazepine of abuse or the presence of other substance use disorders. Significant and clinically relevant improvements were observed in withdrawal and anxiety symptoms, as well as in patients' functioning. At week 12, tolerability was rated as good or excellent by 90% and 83% of the clinicians and patients, respectively. CONCLUSION: Our results suggest that pregabalin is an efficacious and well-tolerated adjunctive treatment for benzodiazepine withdrawal.
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The likelihood of successful BZD discontinuation with pregabalin was not significantly affected by the specific BZD used or the presence of comorbid substance use disorders.
“The likelihood of successful discontinuation was not significantly affected by the specific BZD used or the presence of comorbid substance use disorders. 88”
From Z-drug abuse and dependence: Clinical guideline of the Brazilian Academy of Neurology for diagnosis and management (2025) · cites this paper as [88]
In long-term BZD users, the overall success rate of BZD withdrawal with pregabalin over 12 weeks was 52%.
“Over a 12-week follow-up period, the overall success rate of BZD withdrawal was of 52%.”
From Z-drug abuse and dependence: Clinical guideline of the Brazilian Academy of Neurology for diagnosis and management (2025) · cites this paper as [88]
Existing evidence indicates that gabapentin or pregabalin may offer benefits during BZD withdrawal, either by increasing the likelihood of successful discontinuation or by alleviating anxiety and withdrawal-related symptoms.
“Existing evidence indicates that they may offer benefits during BZD withdrawal, either by increasing the likelihood of successful discontinuation, 87 88 or by alleviating anxiety and withdrawal-related symptoms throughout the tapering process. 89”
From Z-drug abuse and dependence: Clinical guideline of the Brazilian Academy of Neurology for diagnosis and management (2025) · cites this paper as [88]
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- Authors
- Bobes, J., Rubio, G., Terán, A., Cervera, G., López-Gómez, V., Vilardaga, I., & Pérez, M.
- Affiliations
- Universidad de Oviedo (ES)
- Research Institute Hospital 12 de Octubre (ES)
- Hospital Clínico Universitario de Valencia (ES)
- Pfizer (Spain) (ES)
- Corresponding author
- Bobes, J.
- Venue
- European Psychiatry
- Publisher
- Cambridge University Press (CUP)
- Published
- 2012-05
- Volume
- 27
- Issue
- 4
- Pages
- 301-307
- ISSN
- 0924-9338 (ISSN-L)
- 1778-3585
- OpenAlex
- W2154996005
- Cited by
- 57
- References
- 36
- Citations by year
- 2026: 2 · 2025: 1 · 2024: 3 · 2023: 3 · 2022: 3 · 2021: 5 · 2020: 5 · 2019: 2 · 2018: 5 · 2017: 1 · 2016: 2 · 2015: 3 · 2014: 9 · 2013: 5 · 2012: 4
- FWCI
- 5.28
- Type
- journal article
- Language
- en
- Open access
- green
- hdl.handle.net
- Licence
- Locations
- European Psychiatry (publishedVersion)
- PubMed (publishedVersion)
- Consultation of the Doctoral Thesis Database (TESEO) (Ministerio de Educación, Cultura y Deporte) (submittedVersion, cc-by-nc-nd)
- Topics
- Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Opioid Use Disorder Treatment
- Health Sciences › Medicine › Geriatrics and Gerontology › Pharmaceutical Practices and Patient Outcomes
- Keywords
- pregabalin, benzodiazepine withdrawal, benzodiazepine dependence, withdrawal symptoms, anxiety, tolerability, adjunctive therapy, long-term benzodiazepine use
- MeSH terms
- Pregabalin, Adult, Anticonvulsants, Anxiety Disorders, Benzodiazepines, Female, gamma-Aminobutyric Acid, Humans, Male, Middle Aged, Prospective Studies, Surveys and Questionnaires, Substance Withdrawal Syndrome, Anti-Anxiety Agents, Treatment Outcome
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