ADVERTISEMENT
Poster
1575068
Efficacy and Safety of Seltorexant in Insomnia Disorder
Psych Congress 2023
This work was sponsored by Janssen Research & Development, LLC
Background: Current hypnotics for insomnia disorder have limitations (e.g., fall risk/dependency/parasomnia/cognitive impairment). Increasing evidence suggests that orexin antagonists may provide a better approach to treating insomnia due to their potential role in modulating autonomic arousal.
Methods: A multicenter/double-blind/randomized/parallel-group/active- and placebo-controlled/14-day/dose-finding study (NCT03375203) assessed the efficacy and safety of seltorexant, a selective orexin-2 receptor antagonist, in adult and elderly participants with DSM-5 insomnia disorder. Participants were randomized 1:1:1:1:1 to placebo, seltorexant 5mg, 10mg, 20mg, or zolpidem. Primary endpoint: dose-response in LPS change at Night-1 relative to baseline based on PSG. Secondary endpoints included change from baseline in: WASO over the first 6-hours (WASO 6) at Night-1, and LPS and WASO-6 at Night-13. Multiple Comparison Procedure-Modeling, ANCOVA and MMRM were used for data analyses.
Results: Of 365 randomized patients, 347 (95%) completed the double-blind phase with 68% women and median age of 59yr (22-84yr). Statistically significant dose-response relationship (p value
Sign Up
Psych Congress Network Newsletter
