Study of the Safety and Effectiveness of Esmirtazapine in Participants With Chronic Primary Insomnia (P05706)

Phase 3 Completed 526 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to determine if esmirtazapine (Org 50081) is a safe and effective treatment for insomnia. It was anticipated that esmirtazapine would increase mean Total Sleep Time (TST) as recorded in sleep diaries relative to placebo.

Timeline

Start: 2006-12-07
Primary completion: 2008-08-11
Completion: 2008-08-11

Outcome

Met primary endpoint

registry Esmirtazapine 1.5 mg vs Placebo; p <0.0001; ANCOVA NCT00482612 ↗

registry Esmirtazapine 3.0 mg vs Placebo; p <0.0001; ANCOVA NCT00482612 ↗

registry Esmirtazapine 4.5 mg vs Placebo; p <0.0001; ANCOVA NCT00482612 ↗

Publications

Results Ivgy-May N, Roth T, Ruwe F, Walsh J. Esmirtazapine in non-elderly adult patients with primary insomnia: efficacy and safety from a 2-week randomized outpatient trial. Sleep Med. 2015 Jul;16(7):831-7. doi: 10.1016/j.sleep.2015.03.005. Epub 2015 Mar 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Esmirtazapine	Small molecule	1.5 mg	Oral
Subject	Esmirtazapine	Small molecule	3 mg	Oral
Subject	Esmirtazapine	Small molecule	4.5 mg	Oral