%0 Journal Article %1 ancoli-israel_12-week_2010 %A Ancoli-Israel, Sonia %A Krystal, Andrew D %A McCall, W Vaughn %A Schaefer, Kendyl %A Wilson, Amy %A Claus, Raymond %A Rubens, Robert %A Roth, Thomas %D 2010 %J Sleep %K 80 Adverse Age Aged, Azabicyclo Compounds, Disorders, Drug Factors, Female, Humans, Hypnotics Initiation Maintenance Male, Method, Outcome, Patient Piperazines, Reaction Reporting Satisfaction, Sedatives, Sleep Sleep, Systems, Treatment Wakefulness and over, {Double-Blind} %N 2 %P 225--234 %T 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 %U http://www.ncbi.nlm.nih.gov/pubmed/20175406 %V 33 %X 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) \textless or = 6 h, and wake time after sleep onset (WASO) \textgreater 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 \textless 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 \textless 0.0001). Post-discontinuation, sleep parameters were statistically improved versus baseline for eszopiclone (P-values \textless or = 0.01), indicating no rebound. The most common AEs (\textgreater 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

@article{ancoli-israel_12-week_2010, 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)} {\textless} or = 6 h, and wake time after sleep onset {(WASO)} {\textgreater} 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} {\textless} 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} {\textless} 0.0001). Post-discontinuation, sleep parameters were statistically improved versus baseline for eszopiclone {(P-values} {\textless} or = 0.01), indicating no rebound. The most common {AEs} ({\textgreater} 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}}, added-at = {2011-03-11T10:05:34.000+0100}, author = {{Ancoli-Israel}, Sonia and Krystal, Andrew D and {McCall}, W Vaughn and Schaefer, Kendyl and Wilson, Amy and Claus, Raymond and Rubens, Robert and Roth, Thomas}, biburl = {https://www.bibsonomy.org/bibtex/26fb9ef865b6063a8175a882715c55e93/jelias}, interhash = {7e7ed4899c7c39430590220405944ab9}, intrahash = {6fb9ef865b6063a8175a882715c55e93}, issn = {0161-8105}, journal = {Sleep}, keywords = {80 Adverse Age Aged, Azabicyclo Compounds, Disorders, Drug Factors, Female, Humans, Hypnotics Initiation Maintenance Male, Method, Outcome, Patient Piperazines, Reaction Reporting Satisfaction, Sedatives, Sleep Sleep, Systems, Treatment Wakefulness and over, {Double-Blind}}, month = feb, note = {{PMID:} 20175406}, number = 2, pages = {225--234}, timestamp = {2011-03-11T10:05:52.000+0100}, title = {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}, url = {http://www.ncbi.nlm.nih.gov/pubmed/20175406}, volume = 33, year = 2010 }