Psychopharmacology (Berl). 2025 Oct 13. doi: 10.1007/s00213-025-06910-y. Online ahead of print.

ABSTRACT

OBJECTIVE: This systematic review and meta-analysis evaluated the efficacy and safety of trazodone for managing sleep disturbances in patients with depression, addressing its dual role in improving sleep quality and depressive symptoms.

METHODS: Following PRISMA guidelines, a comprehensive search was conducted across PubMed, Scopus, Cochrane Library, PsycInfo, and Web of Science from inception to February 2025. Randomized controlled trials (RCTs) assessing trazodone’s effects on sleep and depression in depressive patients were included. Data extraction, quality assessment using the Cochrane ROB2 tool, and meta-analysis were performed, utilizing the standardized mean difference (SMD) and odds ratios (ORs).

RESULTS: Ten RCTs (1,029 participants) were included. Trazodone significantly improved sleep quality (Pittsburgh Sleep Quality Index: SMD = -0.827, 95% CI: -1.331 to -0.323, p = 0.001) and reduced depression severity (Hamilton Depression Rating Scale: SMD = -0.365, 95% CI: -0.480 to -0.249, p < 0.001). Clinical Global Impression scores showed non-significant trends favoring trazodone (SMD = -0.209, p = 0.118). Adverse effects were more frequent with trazodone, including blurred vision (OR = 17.50, 95% CI: 2.28-134.02), somnolence (OR = 7.34, 95% CI: 2.91-18.50), and sedation (OR = 6.53, 95% CI: 3.59-11.87).

CONCLUSION: Trazodone demonstrates robust efficacy for improving sleep and depressive symptoms in patients with comorbid insomnia and depression. However, its benefits must be weighed against a higher risk of adverse effects, particularly somnolence and visual disturbances. Clinicians should prioritize risk stratification and consider trazodone for patients requiring rapid symptom relief while integrating non-pharmacological interventions for long-term management.

PMID:41081841 | DOI:10.1007/s00213-025-06910-y