Comparison of the impact of amitriptyline and prazepam on sleep quality in patients with pregabalin use disorder

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DOI: 10.48087/BJMS.2026.130307

Authors: Fatema Zohra BENABED1,2,3, Ibtissem BOUTRIF1, NH BENZAZOU1, Meriem BENABED5, Nesrine FEKAR4, Souad GUENDOUZ1,2,3, Mohammed Adil SELKA1,2, Fatma BOUDIA3,6, Hassene BOUCIF1,4, Houari TOUMI3,6

Affiliations: 1- Faculté de médecine de Tlemcen, Université de Tlemcen – Algérie. 2- Service de Pharmacie, CHU Tlemcen– Algérie. 3- Laboratoire de recherche en développement pharmaceutique – Algérie. 4- Service de psychiatrie, CHU Tlemcen – Algérie. 5- Université des Sciences et de la Technologie d’Oran – Algérie. 6- Faculté de Médecine d’Oran, Université d’Oran – Algérie

Abstract

Introduction Sleep disturbances are a frequent and disabling symptom of pregabalin withdrawal and represent a major risk factor for relapse. In the absence of specific therapeutic recommendations, various pharmacological strategies are used in clinical practice to improve withdrawal-related comfort. Objective This study aims to compare the effects of amitriptyline and prazepam on sleep quality in patients with pregabalin use disorder. Materials and Methods This was an open-label comparative study including 40 patients managed in an addiction medicine unit. Patients were divided into two groups receiving either amitriptyline or prazepam as part of a medically supervised withdrawal program. Sleep quality was assessed at baseline and at day 30 using the Pittsburgh Sleep Quality Index (PSQI). A comparative statistical analysis was performed, with the type I error rate (α) set at 5% (p < 0.05). Results A significant improvement in the global PSQI score was observed in both groups after 30 days of treatment. No statistically significant difference was found between the two groups regarding the global PSQI score. However, sleep onset latency was significantly shorter in patients treated with amitriptyline. Conclusion Both amitriptyline and prazepam appear to be effective options for improving sleep quality during pregabalin withdrawal. Amitriptyline may represent a valuable non-benzodiazepine alternative, particularly in patients with predominant sleep-onset insomnia. Larger-scale studies are needed to confirm these findings.

Keywords: Pregabalin, Substance-Related Disorders, Drug Withdrawal Syndrome, Sleep Quality, Pittsburgh Sleep Quality Index.