Fibromyalgia (FM) is a chronic pain disorder with an estimated prevalence of 1%–10% of the general adult population. Pregabalin is approved for the pharmacological drug for FM. The number of systematic review and meta-analysis techniques has also examined the efficacy and safety of Pregabalin. The purpose of this article was to provide an in-depth, evidence-based summary of the clinical studies that have evaluated Pregabalin for the treatment of FM and determined that Pregabalin is a treatment option for FM.

Pregabalin is a licensed medication for the treating fibromyalgia (FM) in Japan, United States, and 37 other countries. This study aimed to present an in-depth, evidence-based review of Pregabalin for FM as shown in placebo-controlled, randomised, clinical studies, involving meta-analyses, combination studies, post-hoc analyses of clinical study data, and open-label extensions.

The Cochrane Library and PubMed were searched using the terms "Pregabalin" and "Pregabalin AND fibromyalgia", respectively on two March 2017 with no other date limits set.

A total of 11 placebo-controlled, randomised, double-blind, clinical studies which involved two-way crossover, a parallel group and randomised withdrawal designs were identified. One was a neuroimaging research. Five open-label extensions were also selected. Evidence of effectiveness was shown over the studies recognised with notable and clinically appropriate improvements in pain, patient status and sleep quality. Pregabalin safety and tolerability profile are constant across all the studies identified, involving in adolescents, with sleepiness and dizziness the most frequent adverse events proclaimed. Meta-analyses supported the safety and efficacy of the data. Pregabalin also showed efficacy when used in combination with other pharmacotherapies. Post-hoc analyses have illustrated the beginning of Pregabalin efficiency as early as 1-2 days following the initiation of the treatment, measured the impact of Pregabalin on other phases of sleep beyond quality, and shown it is capable irrespective of the presence of a wide diversity of patient demographic and clinical features.

The clinical efficacy of Pregabalin for FM has been comprehensively illustrated.