Safety & Efficacy Study of Study Drug (Eszopiclone) in Children and Adolescents With Attention-deficit/Hyperactivity Disorder - Associated Insomnia

Phase 3 Completed 486 enrolled Sumitomo Pharma America, Inc.

RandomizedParallel-groupTriple-blindTreatment

Summary

A multi center, randomized study to evaluate the efficacy and safety of eszopiclone compared to placebo in children (6-11 years of age, inclusive) and adolescents (12-17 years of age, inclusive) with attention deficit/hyperactivity disorder (ADHD) associated insomnia.

Timeline

Start: 2009-05
Primary completion: 2011-07
Completion: 2011-07

Outcome

Missed primary endpoint

paper Neither low-dose nor high-dose eszopiclone significantly reduced latency to persistent sleep compared with placebo after 12 weeks of treatment. PMID 25266438 ↗

registry analysis (superiority or other test); Pooled High Dose Eszopiclone vs Placebo; p >0.05; LS Mean Treatment Difference 7.33 (97.5% CI -5.17 to 19.83); ANCOVA NCT00856973 ↗

registry analysis (superiority or other test); Pooled Low Dose Eszopiclone vs Placebo; p >0.05; LS Mean Treatment Difference 2.21 (97.5% CI -10.23 to 14.65); ANCOVA NCT00856973 ↗

Publications

Sangal RB, Blumer JL, Lankford DA, Grinnell TA, Huang H. Eszopiclone for insomnia associated with attention-deficit/hyperactivity disorder. Pediatrics. 2014 Oct;134(4):e1095-103. doi: 10.1542/peds.2013-4221.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Eszopiclone	Small molecule	1 mg	Oral
Subject	Eszopiclone	Small molecule	2 mg	Oral
Subject	Eszopiclone	Small molecule	3 mg	Oral