TUESDAY, Jan. 16, 2024 (HealthDay News) -- For patients undergoing hemodialysis with chronic insomnia, the effectiveness of cognitive behavioral therapy for insomnia (CBT-I) or trazodone does not differ from placebo, according to a study published online Jan. 16 in the Annals of Internal Medicine.
Rajnish Mehrotra, M.D., from the University of Washington School of Medicine in Seattle, and colleagues compared the effectiveness of CBT-I, trazodone, and placebo for insomnia in a randomized, multicenter trial involving patients undergoing long-term hemodialysis conducted in 26 dialysis units. Overall, 126 patients with chronic insomnia were randomly assigned to six weeks of CBT-I, trazodone, or placebo (43, 42, and 41 patients, respectively).
The researchers found that the change in the Insomnia Severity Index (ISI) score from baseline to seven weeks was no different for CBT-I or trazodone versus placebo (−3.7, −4.2, and −3.1, respectively). From baseline to 25 weeks, there was no meaningful change observed in ISI scores: −4.8, −4.0, and −4.3 with CBT-I, trazodone, and placebo, respectively. Serious adverse events, especially serious cardiovascular events, occurred more often with trazodone (annualized cardiovascular serious adverse event incidence rates: 0.05, 0.64, and 0.21 with CBT-I, trazodone, and placebo, respectively).
"Given the high burden of insomnia in this population and high priority placed by patients for symptom relief, more trials are needed to investigate additional therapies for this condition," the authors write.
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