Eszopiclone treatment for insomnia: Effect size comparisons in patients with primary insomnia and insomnia with medical and psychiatric comorbidity

Andrew D. Krystal, William Vaughn McCall, Maurizio Fava, Hadine Joffe, Claudio N. Soares, Holly Huang, Todd Grinell, Jacqueline Zummo, William Spalding, Randall Marshall

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

Objective: The purpose of this post hoc analysis was to compare the treatment effect size of eszopiclone 3 mg for insomnia in patients with a diagnosis of primary insomnia and in several of the psychiatric and medical conditions that are most commonly comorbid with insomnia. Method: Data were analyzed from 5 large, multicenter, randomized, double-blind, placebo-controlled studies of adult outpatients of at least 1 month duration published between 2006 and 2009. Diary-derived indices of sleep and daytime functioning and the Insomnia Severity Index were compared for patients with primary insomnia (DSM-IV-TR criteria, n = 828) and for those with insomnia comorbid with major depressive disorder (MDD, DSM-IV-TR criteria, n = 545), generalized anxiety disorder (GAD, DSM-IV-TR criteria, n = 595), perimenopause/postmenopause (Stages of Reproductive Aging Workshop criteria, n = 410), and rheumatoid arthritis (American College of Rheumatology criteria, n = 153). Cohen d effect sizes were calculated for each individual study as the between-treatment difference score divided by the pooled standard deviation. Results: Effect sizes ranged from 0.40 to 0.69 (small-medium) as early as week 1 and were maintained at 0.26-0.63 at week 4 for sleep latency, wake time after sleep onset, and total sleep time. Sleep latency and total sleep time effect sizes increased from week 1 to week 4 in the primary insomnia group. At week 4, effect sizes on all 3 parameters and the Insomnia Severity Index tended to be highest for the primary insomnia patients and tended to be lowest for patients with comorbid GAD and MDD. The effect sizes for daytime functioning were small for all insomnia patient groups. Conclusions: Eszopiclone 3 mg is an effective treatment for insomnia across 5 clinically diverse patient populations; however, magnitude of effect is mediated by underlying comorbidity and their treatments, with largest measures of effect seen in primary insomnia and lowest in MDD and GAD. These consistent results, and the fact that clinical trials were conducted in patients being treated as appropriate for their comorbid clinical conditions, support the results' real-world generalizability and utility to clinical practice.

Original languageEnglish (US)
JournalPrimary Care Companion to the Journal of Clinical Psychiatry
Volume14
Issue number4
DOIs
StatePublished - Dec 1 2012

Fingerprint

Sleep Initiation and Maintenance Disorders
Psychiatry
Comorbidity
Sleep
Therapeutics
Diagnostic and Statistical Manual of Mental Disorders
Eszopiclone
Perimenopause
Postmenopause
Major Depressive Disorder
Anxiety Disorders
Rheumatoid Arthritis
Outpatients
Placebos
Clinical Trials
Education

ASJC Scopus subject areas

  • Psychiatry and Mental health

Cite this

Eszopiclone treatment for insomnia : Effect size comparisons in patients with primary insomnia and insomnia with medical and psychiatric comorbidity. / Krystal, Andrew D.; McCall, William Vaughn; Fava, Maurizio; Joffe, Hadine; Soares, Claudio N.; Huang, Holly; Grinell, Todd; Zummo, Jacqueline; Spalding, William; Marshall, Randall.

In: Primary Care Companion to the Journal of Clinical Psychiatry, Vol. 14, No. 4, 01.12.2012.

Research output: Contribution to journalArticle

Krystal, Andrew D. ; McCall, William Vaughn ; Fava, Maurizio ; Joffe, Hadine ; Soares, Claudio N. ; Huang, Holly ; Grinell, Todd ; Zummo, Jacqueline ; Spalding, William ; Marshall, Randall. / Eszopiclone treatment for insomnia : Effect size comparisons in patients with primary insomnia and insomnia with medical and psychiatric comorbidity. In: Primary Care Companion to the Journal of Clinical Psychiatry. 2012 ; Vol. 14, No. 4.
@article{113508c67ab94037ad60c728fd35523c,
title = "Eszopiclone treatment for insomnia: Effect size comparisons in patients with primary insomnia and insomnia with medical and psychiatric comorbidity",
abstract = "Objective: The purpose of this post hoc analysis was to compare the treatment effect size of eszopiclone 3 mg for insomnia in patients with a diagnosis of primary insomnia and in several of the psychiatric and medical conditions that are most commonly comorbid with insomnia. Method: Data were analyzed from 5 large, multicenter, randomized, double-blind, placebo-controlled studies of adult outpatients of at least 1 month duration published between 2006 and 2009. Diary-derived indices of sleep and daytime functioning and the Insomnia Severity Index were compared for patients with primary insomnia (DSM-IV-TR criteria, n = 828) and for those with insomnia comorbid with major depressive disorder (MDD, DSM-IV-TR criteria, n = 545), generalized anxiety disorder (GAD, DSM-IV-TR criteria, n = 595), perimenopause/postmenopause (Stages of Reproductive Aging Workshop criteria, n = 410), and rheumatoid arthritis (American College of Rheumatology criteria, n = 153). Cohen d effect sizes were calculated for each individual study as the between-treatment difference score divided by the pooled standard deviation. Results: Effect sizes ranged from 0.40 to 0.69 (small-medium) as early as week 1 and were maintained at 0.26-0.63 at week 4 for sleep latency, wake time after sleep onset, and total sleep time. Sleep latency and total sleep time effect sizes increased from week 1 to week 4 in the primary insomnia group. At week 4, effect sizes on all 3 parameters and the Insomnia Severity Index tended to be highest for the primary insomnia patients and tended to be lowest for patients with comorbid GAD and MDD. The effect sizes for daytime functioning were small for all insomnia patient groups. Conclusions: Eszopiclone 3 mg is an effective treatment for insomnia across 5 clinically diverse patient populations; however, magnitude of effect is mediated by underlying comorbidity and their treatments, with largest measures of effect seen in primary insomnia and lowest in MDD and GAD. These consistent results, and the fact that clinical trials were conducted in patients being treated as appropriate for their comorbid clinical conditions, support the results' real-world generalizability and utility to clinical practice.",
author = "Krystal, {Andrew D.} and McCall, {William Vaughn} and Maurizio Fava and Hadine Joffe and Soares, {Claudio N.} and Holly Huang and Todd Grinell and Jacqueline Zummo and William Spalding and Randall Marshall",
year = "2012",
month = "12",
day = "1",
doi = "10.4088/PCC.11m01296",
language = "English (US)",
volume = "14",
journal = "The primary care companion for CNS disorders",
issn = "1523-5998",
publisher = "Physicians Postgraduate Press Inc.",
number = "4",

}

TY - JOUR

T1 - Eszopiclone treatment for insomnia

T2 - Effect size comparisons in patients with primary insomnia and insomnia with medical and psychiatric comorbidity

AU - Krystal, Andrew D.

AU - McCall, William Vaughn

AU - Fava, Maurizio

AU - Joffe, Hadine

AU - Soares, Claudio N.

AU - Huang, Holly

AU - Grinell, Todd

AU - Zummo, Jacqueline

AU - Spalding, William

AU - Marshall, Randall

PY - 2012/12/1

Y1 - 2012/12/1

N2 - Objective: The purpose of this post hoc analysis was to compare the treatment effect size of eszopiclone 3 mg for insomnia in patients with a diagnosis of primary insomnia and in several of the psychiatric and medical conditions that are most commonly comorbid with insomnia. Method: Data were analyzed from 5 large, multicenter, randomized, double-blind, placebo-controlled studies of adult outpatients of at least 1 month duration published between 2006 and 2009. Diary-derived indices of sleep and daytime functioning and the Insomnia Severity Index were compared for patients with primary insomnia (DSM-IV-TR criteria, n = 828) and for those with insomnia comorbid with major depressive disorder (MDD, DSM-IV-TR criteria, n = 545), generalized anxiety disorder (GAD, DSM-IV-TR criteria, n = 595), perimenopause/postmenopause (Stages of Reproductive Aging Workshop criteria, n = 410), and rheumatoid arthritis (American College of Rheumatology criteria, n = 153). Cohen d effect sizes were calculated for each individual study as the between-treatment difference score divided by the pooled standard deviation. Results: Effect sizes ranged from 0.40 to 0.69 (small-medium) as early as week 1 and were maintained at 0.26-0.63 at week 4 for sleep latency, wake time after sleep onset, and total sleep time. Sleep latency and total sleep time effect sizes increased from week 1 to week 4 in the primary insomnia group. At week 4, effect sizes on all 3 parameters and the Insomnia Severity Index tended to be highest for the primary insomnia patients and tended to be lowest for patients with comorbid GAD and MDD. The effect sizes for daytime functioning were small for all insomnia patient groups. Conclusions: Eszopiclone 3 mg is an effective treatment for insomnia across 5 clinically diverse patient populations; however, magnitude of effect is mediated by underlying comorbidity and their treatments, with largest measures of effect seen in primary insomnia and lowest in MDD and GAD. These consistent results, and the fact that clinical trials were conducted in patients being treated as appropriate for their comorbid clinical conditions, support the results' real-world generalizability and utility to clinical practice.

AB - Objective: The purpose of this post hoc analysis was to compare the treatment effect size of eszopiclone 3 mg for insomnia in patients with a diagnosis of primary insomnia and in several of the psychiatric and medical conditions that are most commonly comorbid with insomnia. Method: Data were analyzed from 5 large, multicenter, randomized, double-blind, placebo-controlled studies of adult outpatients of at least 1 month duration published between 2006 and 2009. Diary-derived indices of sleep and daytime functioning and the Insomnia Severity Index were compared for patients with primary insomnia (DSM-IV-TR criteria, n = 828) and for those with insomnia comorbid with major depressive disorder (MDD, DSM-IV-TR criteria, n = 545), generalized anxiety disorder (GAD, DSM-IV-TR criteria, n = 595), perimenopause/postmenopause (Stages of Reproductive Aging Workshop criteria, n = 410), and rheumatoid arthritis (American College of Rheumatology criteria, n = 153). Cohen d effect sizes were calculated for each individual study as the between-treatment difference score divided by the pooled standard deviation. Results: Effect sizes ranged from 0.40 to 0.69 (small-medium) as early as week 1 and were maintained at 0.26-0.63 at week 4 for sleep latency, wake time after sleep onset, and total sleep time. Sleep latency and total sleep time effect sizes increased from week 1 to week 4 in the primary insomnia group. At week 4, effect sizes on all 3 parameters and the Insomnia Severity Index tended to be highest for the primary insomnia patients and tended to be lowest for patients with comorbid GAD and MDD. The effect sizes for daytime functioning were small for all insomnia patient groups. Conclusions: Eszopiclone 3 mg is an effective treatment for insomnia across 5 clinically diverse patient populations; however, magnitude of effect is mediated by underlying comorbidity and their treatments, with largest measures of effect seen in primary insomnia and lowest in MDD and GAD. These consistent results, and the fact that clinical trials were conducted in patients being treated as appropriate for their comorbid clinical conditions, support the results' real-world generalizability and utility to clinical practice.

UR - http://www.scopus.com/inward/record.url?scp=84877969362&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84877969362&partnerID=8YFLogxK

U2 - 10.4088/PCC.11m01296

DO - 10.4088/PCC.11m01296

M3 - Article

C2 - 23251857

AN - SCOPUS:84877969362

VL - 14

JO - The primary care companion for CNS disorders

JF - The primary care companion for CNS disorders

SN - 1523-5998

IS - 4

ER -