Off-label uses of trazodone: a review.

INTRODUCTION: Trazodone is an antidepressant belonging to the class of serotonin receptor antagonists and reuptake inhibitors. It is approved by the FDA for the treatment of depression. Insomnia is the most frequent reason for prescription of trazodone. It has also been proven useful in the treatment of anxiety disorders. Other off-label uses include the treatment of bulimia, benzodiazepine/alcohol dependence, fibromyalgia, central nervous system degenerative diseases (behavioral disorders in dementia and other organic disorders), schizophrenia, chronic pain disease and diabetic neuropathy, sexual dysfunction. AREAS COVERED: This paper evaluates trazodone's efficacy and safety in its off-label uses. It also discusses the possibility that a combination of trazodone with SSRIs may prevent or treat some of the SSRI side effects, such as anxiety, insomnia and sexual dysfunction, in addition to synergically increasing SSRIs' antidepressant activity. EXPERT OPINION: Few clinical trials have been conducted to evaluate trazodone's efficacy in the treatment of the diseases and symptoms for which it is often used in clinical practice. More studies are necessary to investigate possible new therapeutic indications, and to scientifically demonstrate the risk/benefit ratio for the many conditions for which trazodone is used, but not approved by the FDA.