No differences in insomnia with behavioral therapy, trazodone in patients on dialysis
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Key takeaways:
- There were no major differences in the change of insomnia scores from baseline to 7 weeks.
- The found serious adverse cardiovascular events were more frequent with trazodone.
There was no difference in for adults on hemodialysis with mild or moderate chronic insomnia, recently published data.
Rajnish Mehrotra, MD, MS, the Kidney Research Institute at University of Washington School of Medicine wrote that insomniacharacterized by dissatisfaction with sleep quality or durationis more common in pon long-term dialysis.
“We undertook this trial to compare the short- and long-term effectiveness and safety of [cognitive behavioral therapy] delivered by telehealth, trazodone and placebo for treating chronic insomnia in patients undergoing in-center hemodialysis,” they wrote in the study.
Researchers conducted a multicenter, double-blinded clinical trial that encompassed 26 dialysis units in Albuquerque, New Mexico, and Seattle. Patients were randomly assigned to 6 weeks of cognitive behavioral therapy for insomnia, the sleep aid trazodone or a placebo.
A total of 411 patients undergoing in-center hemodialysis met chronic insomnia criteria for the trial, with 126 randomly assigned to CBT-I (N = 43), trazodone (N = 42) or placebo (N = 41). Participants had an insomnia severity index (ISI) score of 10 or greater and reported sleep disturbances at least 3 nights per week for at least 3 months.
The primary outcome change in ISI scores at 7 and 25 weeks from randomization.
Researchers found no major difference in the change of ISI scores from baseline to 7 weeks between the three groups. Respectively, the differences were as follows: cognitive behavioral therapy, –3.7; trazodone, –4.2; and placebo, –3.1. There were also no meaningful changes in ISI from baseline to 25 weeks in any group, according to the study results.
The researchers highlighted that serious adverse events, particularly cardiovascular events, were more frequent in patients in the trazodone group compared with the other groups. The annualized cardiovascular series adverse event incidence rates were 0.05 for cognitive behavioral therapy, 0.64 for trazodone and 0.21 for placebo.
“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,” Mehrotra and colleagues wrote.
Reference:
Trazadone and CBT no more effective than placebo for improving insomnia among long-term dialysis patients. https://www.newswise.com/articles/trazadone-and-cbt-no-more-effective-than-placebo-for-improving-insomnia-among-long-term-dialysis-patients. Published Jan. 9, 2024. Accessed Jan. 9, 2023.
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