

Two reviewers conducted a focused analysis using the full-text articles independently and reached a consensus on the studies to include in this review. This strategy identified 173 articles that were screened 55 were related to the topic. A MEDLINE search of the literature from 1983 through 2016 was conducted using the keywords insomnia, trazodone, sedative, and hypnotics and restricted to English language and human subjects. 8 – 10 Given this widespread use, it seems beneficial to evaluate the literature on the efficacy and safety of trazodone when administered for the treatment of insomnia. However, trazodone was recently among the most widely prescribed sleep aids in the United States, despite being approved for depression by the Food and Drug Administration (FDA). Currently, benzodiazepine receptor agonists (BzRAs), such as Zolpidem (Ambien) have been the preferred treatment of insomnia. Effective treatment requires appropriate diagnosis, as well as behavioral and pharmacological therapy. 7 Secondary insomnia might be caused by psychiatric or medical disorders, environmental factors, changes in circadian rhythm, or medication use. 2 – 6 Primary insomnia is an organic illness in which sleep disturbances last longer than one month and have no identifiable etiology. Insomnia is characterized by difficulty falling asleep, difficulty staying asleep, or waking too early 1 and is associated with significant impairments in daytime activities, which might occur despite adequate opportunities for sleep. CONCLUSION: A review of the literature suggests that there are adequate data supporting the efficacy and general safety of the low-dose use of trazodone for the treatment of insomnia. The side effects are dose-dependent, and the most common is drowsiness.

Earlier studies (1980–2000) focused on utilizing trazodone at high doses (≥100mg/d) for the treatment of insomnia among the depressed population however, since the 2000s, the utility of trazodone has been expanded to treat secondary insomnia among the non-depressed population as well. RESULTS: Evidence for the efficacy of trazodone has been repeatedly demonstrated for primary insomnia, as well as secondary insomnia, including for symptoms that are a result of depression, dementia, and being a healthy man. The study selection process yielded a total of 45 studies. All randomized clinical trials, meta-analyses, observational studies, and placebo-controlled trials regarding trazodone for the treatment of primary or secondary insomnia were reported, per PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. The results were restricted to English language and human subjects. METHODS: A literature search was conducted using MEDLINE/PubMed databases from the past 33 years (1983–2016) and the keywords insomnia, trazodone, sedative, treatment, and hypnotics. In this systematic review, we examined the evidence for the efficacy and safety of trazodone for insomnia. OBJECTIVE: While trazodone is approved for the treatment of depression, the off-label use of this medication for insomnia has surpassed its usage as an antidepressant.
