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

Sonia Ancoli-Israel, Andrew D. Krystal, William Vaughn McCall, Kendyl Schaefer, Amy Wilson, Raymond Claus, Robert Rubens, Thomas Roth

Research output: Contribution to journalArticle

49 Citations (Scopus)

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) ≤ 6 h, and wake time after sleep onset (WASO) ≥ 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 eszopiclonetreated subjects was 360.08 min compared to 297.86 min at baseline, a mean change of 63.24 min. Over the double-blind period, eszopiclonetreated subjects also experienced a significantly greater improvement in sSL compared to placebo, with a mean decrease of 24.62 min versus 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 ≤ 0.01), indicating no rebound. The most common AEs (≥ 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.

Original languageEnglish (US)
Pages (from-to)225-234
Number of pages10
JournalSleep
Volume33
Issue number2
StatePublished - Feb 1 2010

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Sleep Initiation and Maintenance Disorders
Sleep
Placebos
Nasopharyngitis
Safety
Eszopiclone
Aptitude
Diagnostic and Statistical Manual of Mental Disorders
Headache
Outpatients
Clinical Trials

Keywords

  • Elderly
  • Eszopiclone
  • Next day function
  • Primary insomnia
  • Sleep

ASJC Scopus subject areas

  • Clinical Neurology
  • Physiology (medical)

Cite this

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. / Ancoli-Israel, Sonia; Krystal, Andrew D.; McCall, William Vaughn; Schaefer, Kendyl; Wilson, Amy; Claus, Raymond; Rubens, Robert; Roth, Thomas.

In: Sleep, Vol. 33, No. 2, 01.02.2010, p. 225-234.

Research output: Contribution to journalArticle

Ancoli-Israel, Sonia ; Krystal, Andrew D. ; McCall, William Vaughn ; Schaefer, Kendyl ; Wilson, Amy ; Claus, Raymond ; Rubens, Robert ; Roth, Thomas. / 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. In: Sleep. 2010 ; Vol. 33, No. 2. pp. 225-234.
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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) ≤ 6 h, and wake time after sleep onset (WASO) ≥ 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 eszopiclonetreated subjects was 360.08 min compared to 297.86 min at baseline, a mean change of 63.24 min. Over the double-blind period, eszopiclonetreated subjects also experienced a significantly greater improvement in sSL compared to placebo, with a mean decrease of 24.62 min versus 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 ≤ 0.01), indicating no rebound. The most common AEs (≥ 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.",
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T1 - 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

AU - Ancoli-Israel, Sonia

AU - Krystal, Andrew D.

AU - McCall, William Vaughn

AU - Schaefer, Kendyl

AU - Wilson, Amy

AU - Claus, Raymond

AU - Rubens, Robert

AU - Roth, Thomas

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N2 - 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) ≤ 6 h, and wake time after sleep onset (WASO) ≥ 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 eszopiclonetreated subjects was 360.08 min compared to 297.86 min at baseline, a mean change of 63.24 min. Over the double-blind period, eszopiclonetreated subjects also experienced a significantly greater improvement in sSL compared to placebo, with a mean decrease of 24.62 min versus 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 ≤ 0.01), indicating no rebound. The most common AEs (≥ 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.

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KW - Eszopiclone

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