The insomnia with objective short sleep duration (ISS) phenotype, is associated with increased risk for adverse health outcomes, physiological hyperarousal, and a blunted response to Cognitive-Behavioral Treatment for Insomnia (CBT-I). Whether ISS responds better to pharmacological compared to CBT-I has not been examined.
Participants included 15 chronic insomniacs (86.7% female) 45.3 ± 8.1 years old. Eight patients were randomized to CBT-I and seven to trazodone. Patients were examined with two weeks actigraphy, salivary cortisol, and the insomnia severity index (ISI) at three time points (pre-treatment, 3-month post-treatment, and 6-month follow-up). Mixed between-within subjects analysis of variance and univariate analysis of covariance were conducted to assess the impact of trazodone and CBT-I on patients’ total sleep time (TST), salivary cortisol, and ISI scores across three time points.
Trazodone, but not CBT-I, significantly lengthened TST (when measured with actigraphy) both at post-treatment (51.01 versus -11.73 minutes; p = 0.051, Cohen’s d = 1.383) and at follow-up (50.35 versus -7.56 minutes; p = 0.012, Cohen’s d = 1.725) respectively. Additionally, trazodone, but not CBT-I, had a clinically meaningful decrease in salivary cortisol from pre-treatment to post-treatment (-36.07% versus -11.70%; Cohen’s d = 0.793) and to follow-up (-21.37% versus -5.79%; Cohen’s d = 0.284) respectively. Finally, there were no differences on ISI scores between trazodone and CBT-I groups.
The current preliminary, open-label, randomized trial suggests that trazodone, but not CBT-I, significantly improves objective sleep duration and reduces HPA axis activation, suggesting a differential treatment response in the ISS phenotype.
Registry: ClinicalTrials.gov; Identifier: NCT01348542.
© 2020 American Academy of Sleep Medicine.