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.
BACKGROUND
Longer-term pharmacologic studies for insomnia in older individuals are sparse.


OBJECTIVE
To evaluate the efficacy and safety of 12 weeks of nightly eszopiclone in elderly outpatients with insomnia.


METHODS
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.


RESULTS
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%).


CONCLUSIONS
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.


BACKGROUND
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
Ancoli-Israel
Sonia
S
Department of Psychiatry, University of California San Diego, San Diego, CA 92093-0733, USA. sancoliisrael@ucsd.edu
Krystal
Andrew D
AD
McCall
W Vaughn
WV
Schaefer
Kendyl
K
Wilson
Amy
A
Claus
Raymond
R
Rubens
Robert
R
Roth
Thomas
T
D016907:Adverse Drug Reaction Reporting Systems; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D053961:Azabicyclo Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D000069582:Eszopiclone; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D017060:Patient Satisfaction; D010879:Piperazines / Q000008:administration & dosage* / Q000009:adverse effects; D012890:Sleep / Q000187:drug effects*; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy*; D016896:Treatment Outcome; D014851:Wakefulness / Q000187:drug effects*
D053961:Azabicyclo Compounds; D006993:Hypnotics and Sedatives; D010879:Piperazines; D000069582:Eszopiclone