• Rajnish Mehrotra, Daniel Cukor, Susan M McCurry, Tessa Rue, Maria-Eleni Roumelioti, Patrick J Heagerty, and Mark Unruh.
• Kidney Research Institute, Division of Nephrology, Department of Medicine, University of Washington School of Medicine, Seattle, Washington (R.M.).
• Ann. Intern. Med. 2024 Feb 1; 177 (2): 177188177-188.

BackgroundChronic insomnia is common in patients undergoing in-center hemodialysis, yet there is limited evidence on effective treatments for this population.ObjectiveTo compare the effectiveness of cognitive behavioral therapy for insomnia (CBT-I), trazodone, and placebo for insomnia in patients undergoing long-term hemodialysis.DesignRandomized, multicenter, double-blinded, placebo-controlled trial. (ClinicalTrials.gov: NCT03534284).Setting26 dialysis units in Albuquerque, New Mexico, and Seattle, Washington.ParticipantsPatients with Insomnia Severity Index (ISI) score of 10 or greater, with sleep disturbances on 3 or more nights per week for 3 or more months.InterventionParticipants were randomly assigned to 6 weeks of CBT-I, trazodone, or placebo.MeasurementsThe primary outcome was the ISI score at 7 and 25 weeks from randomization.ResultsA total of 923 patients were prescreened, and of the 411 patients with chronic insomnia, 126 were randomly assigned to CBT-I (n = 43), trazodone (n = 42), or placebo (n = 41). The change in ISI scores from baseline to 7 weeks with CBT-I or trazodone was no different from placebo: CBT-I, -3.7 (95% CI, -5.5 to -1.9); trazodone, -4.2 (CI, -5.9 to -2.4); and placebo, -3.1 (CI, -4.9 to -1.3). There was no meaningful change in ISI scores from baseline to 25 weeks: CBT-I, -4.8 (CI, -7.0 to -2.7); trazodone, -4.0 (CI, -6.0 to -1.9); and placebo, -4.3 (CI, -6.4 to -2.2). Serious adverse events (SAEs), particularly serious cardiovascular events, were more frequent with trazodone (annualized cardiovascular SAE incidence rates: CBT-I, 0.05 [CI, 0.00 to 0.29]; trazodone, 0.64 [CI, 0.34 to 1.10]; and placebo, 0.21 [CI, 0.06 to 0.53]).LimitationModest sample size and most participants had mild or moderate insomnia.ConclusionIn patients undergoing hemodialysis with mild or moderate chronic insomnia, there was no difference in the effectiveness of 6 weeks of CBT-I or trazodone compared with placebo. The incidence of SAEs was higher with trazodone.Primary Funding SourceNational Institutes of Health/National Institute of Diabetes and Digestive and Kidney Diseases.

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