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.

Abstract

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%).

CONCLUSION:

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.

CLINICAL TRIAL INFORMATION:

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

• Authors: Sonia Ancoli-Israel, Andrew D Krystal, W Vaughn McCall, Kendyl Schaefer, Amy Wilson, Raymond Claus, Robert Rubens, Thomas Roth
• Journal: Sleep (Sleep) Vol. 33 Issue 2 Pg. 225-34 (Feb 2010) ISSN: 0161-8105 [Print] United States
• PMID: 20175406 (Publication Type: Clinical Trial, Phase IV, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Azabicyclo Compounds
• Hypnotics and Sedatives
• Piperazines
• Eszopiclone

Topics

• Adverse Drug Reaction Reporting Systems
• Age Factors
• Aged
• Aged, 80 and over
• Azabicyclo Compounds (administration & dosage, adverse effects)
• Double-Blind Method
• Eszopiclone
• Female
• Humans
• Hypnotics and Sedatives (administration & dosage, adverse effects)
• Male
• Patient Satisfaction
• Piperazines (administration & dosage, adverse effects)
• Sleep (drug effects)
• Sleep Initiation and Maintenance Disorders (drug therapy)
• Treatment Outcome
• Wakefulness (drug effects)