A Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42847922 in Participants With Insomnia Disorder

Phase 2 Completed 365 enrolled Janssen Research & Development, LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this 2 month phase 2b study is to investigate the dose response of 3 doses of JNJ-42847922 (Seltorexant) (5,10 and 20 mg) compared to placebo and zolpidem on sleep onset and maintenance and to further document safety and tolerability of JNJ-42847922 (Seltorexant) upon multiple (14 days) dose administration in participants with insomnia disorder.

Timeline

Start: 2017-11-23
Primary completion: 2019-04-03
Completion: 2019-04-03

Outcome

Met primary endpoint

registry Placebo vs JNJ-42847922 10 mg; p = 0.001; Back-transformed Least Square Mean Ratio 0.64 (90% CI 0.51 to 0.81); ANCOVA NCT03375203 ↗

registry Placebo vs JNJ-42847922 20 mg; p < 0.001; Back-transformed Least Square Mean Ratio 0.51 (90% CI 0.41 to 0.64); ANCOVA NCT03375203 ↗

paper with greater improvements in seltorexant, 10 mg and 20 mg, vs placebo PMID 40802194 ↗

Publications

Mesens S, Krystal AD, Melkote R, Xu H, Pandina G, Saoud JB, Luthringer R, Savitz A, Drevets WC. Efficacy and Safety of Seltorexant in Insomnia Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2025 Aug 13;82(10):967-76. doi: 10.1001/jamapsychiatry.2025.1999. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Seltorexant	Small molecule	5 mg	Oral
Subject	Seltorexant	Small molecule	10 mg	Oral
Subject	Seltorexant	Small molecule	20 mg	Oral
Subject	Zolpidem	Small molecule	5 mg	Oral
Subject	Zolpidem	Small molecule	10 mg	Oral