A 12-Week, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Effect of Eszopiclone 2 mg on Sleep/Wake Function in Older Adults with Primary and Comorbid Insomnia

• Published in: Sleep (New York, N.Y.) N.Y.), 2010-02, Vol.33 (2), p.225-234
• Main Authors: ANCOLI-ISRAEL, Sonia, KRYSTAL, Andrew D, VAUGHN MCCALL, W, SCHAEFER, Kendyl, WILSON, Amy, CLAUS, Raymond, RUBENS, Robert, ROTH, Thomas
• Format: Article
• Language: English
• Subjects: Adverse Drug Reaction Reporting Systems; Age Factors; Aged; Aged, 80 and over; Azabicyclo Compounds - administration & dosage; Azabicyclo Compounds - adverse effects; Behavioral psychophysiology; Biological and medical sciences; Disorders of higher nervous function. Focal brain diseases. Central vestibular syndrome and deafness. Brain stem syndromes; Double-Blind Method; Effect of Eszopiclone on Insomnia in the Elderly; Eszopiclone; Female; Fundamental and applied biological sciences. Psychology; Humans; Hypnotics and Sedatives - administration & dosage; Hypnotics and Sedatives - adverse effects; Male; Medical sciences; Nervous system (semeiology, syndromes); Neurology; Patient Satisfaction; Piperazines - administration & dosage; Piperazines - adverse effects; Psychology. Psychoanalysis. Psychiatry; Psychology. Psychophysiology; Sleep - drug effects; Sleep Initiation and Maintenance Disorders - drug therapy; Treatment Outcome; Wakefulness - drug effects
• ISSN: 0161-8105; 1550-9109
• DOI: 10.1093/sleep/33.2.225

Longer-term pharmacologic studies for insomnia in older individuals are sparse. To evaluate the efficacy and safety of 12 weeks of nightly eszopiclone in elderly outpatients with insomnia. Participants (65-85 years) met DSM-IV-TR criteria for insomnia with total sleep times (TST) < or = 6 h, and wake time after sleep onset (WASO) > or = 45 min. Participants were randomized to 12 weeks of eszopiclone 2 mg (n = 194) or placebo (n = 194), followed by a 2-week single-blind placebo run-out. Subject-reported measures of sleep (sTST, sleep latency [sSL], sWASO) and daytime function (alertness, concentration, wellbeing, ability to function) were assessed. AEs were monitored. Subjects treated with 2 mg eszopiclone slept longer at night on average and at every individual time point compared to baseline than placebo subjects, as measured by TST over the 12-week double-blind period (P < 0.0001). Mean sTST over the double-blind period for eszopiclone-treated subjects was 360.08 min compared to 297.86 min at baseline, a mean change of 63.24 min. Over the double-blind period, eszopiclone-treated subjects also experienced a significantly greater improvement in sSL compared to placebo, with a mean decrease of 24.62 min versus a mean decrease of 19.92 min, respectively (P = 0.0014). Eszopiclone subjects also experienced a significantly greater decrease in WASO (mean decrease of 36.4 min) compared to placebo subjects (decrease of 14.8 min) (P < 0.0001). Post-discontinuation, sleep parameters were statistically improved versus baseline for eszopiclone (P-values < or = 0.01), indicating no rebound. The most common AEs (> or = 5%) were headache (eszopiclone 13.9%, placebo 12.4%), unpleasant taste (12.4%, 1.5%), and nasopharyngitis (5.7%, 6.2%). In this Phase IV trial of older adults with insomnia, eszopiclone significantly improved patient-reported sleep and daytime function relative to placebo. Improvements occurred within the first week and were maintained for 3 months, with no evidence of rebound insomnia following discontinuation. The 12 weeks of treatment were well tolerated. A Long-Term Safety and Efficacy Study of Eszopiclone in Elderly Subjects With Primary Chronic Insomnia; Registration #NCT00386334; URL - http://www.clinicaltrials.gov/ct2/show/NCT00386334?term=eszopiclone&rank=24