0373 Trazodone vs. Cognitive Behavioral Therapy in Insomnia with Short Sleep Duration: Effects on Total Sleep Time and Cortisol Levels

Abstract

Introduction: Several studies have shown that the insomnia with short sleep duration phenotype is associated with significant activation of the stress system and cardiometabolic morbidity. In this study we examined the effects of pharmacological vs. cognitive behavioral therapy for insomnia (CBT-I) on objective total sleep time (TST) and cortisol levels. Methods: A volunteer sample of 20 men and women (80% female, 43.9 ± 9.9y, 26.56 ± 4.07 kg/m2) were randomized to either Trazodone (n=10) or CBT-I (n=10). Two-week TST, as measured by actigraphy, and evening (18:00-21:00) saliva cortisol levels were measured at pre-treatment and 3 months later at post-treatment. Results: There was no significant effect of either treatment on objective TST or cortisol levels in the overall sample (n=20). However, when we focused on those with short sleep duration (<7h TST) there was a large increase in objective TST with trazodone (Δ=59.85 ± 68.45 min, paired-t=2.313, Cohen's d=0.87, n=7) vs. a small decrease with CBT-I (Δ=-6.08 ± 38.02 min, t=-0.424, Cohen's d=0.16, n=7). An analysis of covariance adjusting for sex, age, and BMI showed a significant effect of trazodone (n=7) vs. CBT-I (n=7) in increasing objective TST (64.75 ± 24.58 min, p=0.027). Trazodone (Δ=-3.23 ± 4.11 ng/mL, t=-1.92, Cohen's d=0.8), in contrast to CBT-I (Δ=-0.51 ± 2.48 ng/mL, t=-0.54, Cohen's d=0.2), was associated with a clinically meaningful impact on decreasing cortisol levels. Finally, there was a significant correlation between decreasing cortisol levels and increasing objective TST over the course of treatment (r=-0.484, p=0.036). Conclusion: These pilot data suggest that trazodone, but not CBT-I, increases objective TST in insomniacs with short sleep duration and this appears to be mediated by a downregulation of the stress system. These data support our hypothesis that pharmacological treatments are more effective than behavioral treatments in the insomnia with short sleep duration phenotype.