A 6-Month Efficacy and Safety Study of Org 50081 in Adult Patients With Chronic Primary Insomnia (21106/P05701/MK-8265-002)

Phase 3 Completed 460 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupTriple-blindTreatment

Summary

To investigate the long-term efficacy and safety of treatment with esmirtazapine (Org 50081, SCH 900265, MK-8265) compared to placebo, in participants with chronic primary insomnia. Primary efficacy variable is Total Sleep Time (TST).

Timeline

Start: 2008-03-04
Primary completion: 2009-11-19
Completion: 2009-11-19

Outcome

Met primary endpoint

registry Esmirtazapine 4.5 mg vs Placebo; p <0.0001; Difference in Least Squares (LS) Means 48.7 (95% CI 35.0 to 62.5); ANCOVA NCT00631657 ↗

paper In the double-blind study, a 48.7-minute increase in average nightly total sleep time was observed for esmirtazapine vs placebo (95% confidence interval, 35.0-62.5; P < .0001) at months 4-6. PMID 32351205 ↗

Publications

Ivgy-May N, Hajak G, van Osta G, Braat S, Chang Q, Roth T. Efficacy and safety of esmirtazapine in adult outpatients with chronic primary insomnia: a randomized, double-blind placebo-controlled study and open-label extension. J Clin Sleep Med. 2020 Sep 15;16(9):1455-1467. doi: 10.5664/jcsm.8526.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Esmirtazapine	Small molecule	4.5 mg	—