Trazodone, CBT for insomnia only as good as placebo in haemodialysis patients

Cognitive behavioural therapy for insomnia (CBT-I) or trazodone appear to be no better than placebo in the treatment of insomnia among patients undergoing long-term haemodialysis, reveals a study. In addition, trazodone use is associated with a higher incidence of serious adverse events (SAEs).

This randomized controlled trial was conducted in 26 dialysis units in Albuquerque, New Mexico, and Seattle, Washington. The investigators identified patients with Insomnia Severity Index (ISI) score of 10 or higher, with sleep disturbances on three or more nights per week for 3 or more months.

Nine hundred twenty-three patients underwent prescreening, and 411 were found to have chronic insomnia. Of these, 126 were randomized to CBT-I (n=43), trazodone (n=42), or placebo (n=41).

From baseline to 7 weeks, change in ISI scores did not significantly differ between CBT-I or trazodone and placebo (CBT-I, ‒3.7, 95 percent confidence interval [CI], ‒5.5 to ‒1.9; trazodone, ‒4.2, 95 percent CI, ‒5.9 to ‒2.4; and placebo, ‒3.1, 95 percent CI, ‒4.9 to ‒1.3).

Likewise, change in ISI scores from baseline to 25 weeks was not substantial (CBT-I, ‒4.8, 95 percent CI, ‒7.0 to ‒2.7; trazodone, ‒4.0, 95 percent CI, ‒6.0 to ‒1.9; and placebo, ‒4.3, 95 percent CI, ‒6.4 to ‒2.2).

Notably, treatment with trazodone was associated with more frequent SAEs, particularly serious cardiovascular events (annualized cardiovascular SAE incidence rates: CBT-I, 0.05, 95 percent CI, 0.00‒0.29; trazodone, 0.64, 95 percent CI, 0.34‒1.10; and placebo, 0.21, 95 percent CI, 0.06‒0.53).

The study was limited by its modest sample size. In addition, several participants presented with mild or moderate insomnia.