However, since the end of the last century, a few studies determined that it possesses sedative and hypnotic action from the antagonistic mechanism at the α1- and α2-adrenergic receptors, 5-HT2A receptors, and histamine H1 receptors 4, 5, 6. It is a second-generation triazolopyridine derivative in the category of serotonin antagonist and reuptake inhibitors (SARI) drugs and is used as an antidepressant 3. Among medications, trazodone is controversial for its use as a sleeping aid. Pharmacotherapy is one of the major approaches to the treatment of insomnia disorder 2. Insomnia disorder is a prevalent disorder, and approximately one-third of the general population presents insomnia symptoms 1. PROSPERO registration register name: The effect of trazodone on polysomnography sleep architecture in patients with insomnia: a systematic review and meta-analysis protocol Registration Number CRD42020215332. Trazodone could improve sleep by changing the sleep architecture in insomnia disorder, but it should be used with caution due to the adverse events that may occur. Trials with combination of other therapy could be a problem in this meta-analysis as the possibility of interactions were found from sungroup analysis. The sources of heterogeneity in TST and N3 were not found out from sensitive and subgroup analysis and there was no high quality of evidence in outcomes by GRADE Assessment. The results of quality of evidence were very low in TST, N3 and AHI, were low in LPS, WASO and REM, and were moderate in N1 and NAs. Daytime drowsiness (OR = 2.53, 95% CI 1.14–5.64, P = 0.02) and decreased appetite (OR = 2.81, 95% CI 1.14–6.92, P = 0.02) occurred with greater frequency in the trazodone group as compared to the control group, and the differences were significant. Risk of bias was low in 5 trials (45.5%), and was moderate in 6 (54.5%). Eleven randomized controlled trials were selected and participants were 466. The mean differences (MD) or standardized mean differences (SMD) and odds ratios (OR) with 95% confidence intervals (CIs) were estimated. When I 2 ≥ 50%, the random effects model was used. When I 2 < 50%, the fixed effects model was used. The results of quality of evidence assessed by the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. RoB 2 was used to evaluate the risk of bias. RCTs in patients with insomnia disorder applying trazodone in one arm of interventions at least 1 week, and reporting PSG parameters in the outcomes were eligible. PubMed, EMBASE, Web of Science, PsycINFO, Cochrane Library, Chinese Biomedical Literature Database (SinoMed), China National Knowledge Infrastructure, Wanfang Database, and the China Science and Technology Journal Database were searched for articles published between inception and June 2022. To assess the efficacy of trazodone in altering the polysomnographic sleep architecture in insomnia disorder so that sleep can be facilitated. Identifying how trazodone impacts the performance of polysomnographic sleep architecture in insomnia disorder will provide additional data that can be used to guide clinical application. Trazodone has been widely prescribed for off-label use as a sleep aid.
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