Pregabalin is a new anxiolytic that has been recently licensed for the treatment of generalised anxiety disorder (GAD) in Europe. Short-term efficacy is based on six positive placebo-controlled studies, all of which showed a significant early separation from placebo in all of the doses used (150-600 mg) at the first week, and the efficacy at the end of the treatment was comparable with the comparators used in four of these studies. Pregabalin was effective in more or less severe GAD, on psychic and somatic symptoms of GAD, and in treating the subsyndromal depressive symptoms of GAD. Efficacy in the elderly was shown in a separate placebo-controlled study. The effect on cognitive function was minimal and notably less than that observed with benzodiazepines. The discontinuation symptoms following abrupt treatment cessation were similar to the rates with serotonin-noradrenaline re-uptake inhibitors and lower than with benzodiazepines with no signals of tolerance or dependence.