PHARMACOVIGILANCE AND OFF-GUIDELINE USE FOR GABAPENTIN IN FIBROMYALGIA: A REVIEW OF SAFETY PROFILES AND PRESCRIBING PATTERNS

Abstract

Fibromyalgia (FM) is a multifactorial chronic pain syndrome that significantly affects patients' quality of life. Despite the widespread use of gabapentinoids such as gabapentin, their off-label use in FM treatment remains controversial due to inconsistent efficacy and safety concerns. This systematic review aims to map the current state of knowledge in the field. of off-guideline use of  gabapentin use in FM by synthesizing findings from four selected studies published between 2020 and 2025. The studies reviewed include clinical and preclinical trials assessing gabapentin monotherapy, its extended-release formulations, and combinations with osteopathic manipulative medicine (OMM) or natural compounds like sulforaphane. Results suggest that combination therapies offer superior pain relief compared to gabapentin alone. Notably, extended-release gabapentin demonstrated improved adherence and reduced side effects. Furthermore, mirogabalin, a novel gabapentinoid, was found to enhance both pain control and cognitive function ("fibro fog") in animal models. However, reported side effects such as dizziness and drowsiness, along with limitations in study design and sample size, emphasize the need for further randomized controlled trials. This review highlights the evolving role of gabapentinoids in FM treatment and underscores the importance of integrated therapeutic strategies for optimal patient outcomes.