Eszopiclone for insomnia associated with attention-deficit/hyperactivity
disorder.
Author(s): Sangal RB(1), Blumer JL(2), Lankford DA(3), Grinnell TA(4), Huang H(4).
Affiliation(s): Author information:
(1)Sleep Disorders Institute and Attention Disorders Institute, Sterling Heights,
Michigan; Oakland University William Beaumont School of Medicine, Rochester
Hills, Michigan; sangalrb@sleepwebmd.com. (2)Department of Pediatrics, College of
Medicine and Life Sciences, The University of Toledo, Toledo, Ohio; (3)Sleep
Disorders Center of Georgia, Atlanta, Georgia; and. (4)Sunovion Pharmaceuticals,
Inc, Marlborough, Massachusetts.
Publication date & source: 2014, Pediatrics. , 134(4):e1095-103
OBJECTIVE: To evaluate efficacy and safety of eszopiclone compared with placebo
in children and adolescents with insomnia associated with
attention-deficit/hyperactivity disorder (ADHD).
METHODS: A 12-week, randomized, double-blind, placebo-controlled trial evaluated
efficacy and safety of high- or low-dose eszopiclone (1 or 2 mg in children aged
6-11 years, 2 or 3 mg in children ages 12-17 years), given every evening, in 486
patients with ADHD-related insomnia. The primary efficacy variable was change in
latency to persistent sleep from baseline to week 12, based on polysomnography.
Key secondary measures were polysomnography-measured wake time after sleep onset,
Clinical Global Impression Parent/Caregiver and Child scales, and the Conners'
ADHD rating scales. The safety of eszopiclone was further studied over 1 year of
open-label treatment in 55 patients who completed the double-blind study, and 249
patients with no previous eszopiclone exposure.
RESULTS: Neither low-dose nor high-dose eszopiclone significantly reduced latency
to persistent sleep compared with placebo after 12 weeks of treatment. Secondary
outcomes were considered nonsignificant based on the hierarchical statistical
analysis plan. The most frequent treatment-emergent adverse events over 12 weeks
with eszopiclone were headache, dysgeusia, and dizziness. The study results
demonstrated that eszopiclone was well tolerated over 1 year of treatment, with
11.2% of patients discontinuing open-label treatment because of an adverse event.
CONCLUSIONS: Eszopiclone (up to 3 mg) failed to reduce latency to persistent
sleep on polysomnography after 12 weeks in children aged 6 to 17 years with
ADHD-related insomnia. Eszopiclone was well tolerated in the 1-year study.
|