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

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

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

Indications