Main Article Content
INTRODUCTION: Insomnia is a frequent complaint in primary care, with a negative impact on patients´ quality of life. Therefore, its proper treatment is essential. Trazodone is a drug that has been widely used in insomnia treatment, although it is only approved by INFARMED and Food and Drug Administration (FDA) for depression treatment. Therefore, it is relevant to review the evidence supporting this off-label use.
METHODOLOGY: Using evidence-based medicine websites, a research of meta-analyzes, systematic reviews, clinical trials and guidelines were completed by using the MeSH terms “Trazodone” and “Sleep Initiation and Maintenance Disorders” and the keywords “Trazodone” and “Insomnia”. Afterwards, the articles published in English and Portuguese between 19/05/2008 and 19/05/2018 were selected.
RESULTS: The review included 10 articles: 2 meta-analyzes, 3 systematic reviews, 2 clinical trials and 3 guidelines. Meta-analyzes revealed that trazodone is effective in treating insomnia (level of evidence -LE- 2), as was observed in clinical trials (LE 2) and in two systematic reviews (LE 2), with the third review reporting no evidence to draw conclusions. Regarding the guidelines, two support the use of trazodone (recommendation strength -RS- B and RS C) while the third suggests its non-use (RS B).
CONCLUSION: There is limited evidence that trazodone is effective in insomnia treatment - Recommendation Strength B. It is important that further researches be conducted to reinforce the use of trazodone in insomnia treatment.