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Sleep Initiation and Maintenance Disorders: HELP
Articles by James K. Walsh
Based on 28 articles published since 2008
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Between 2008 and 2019, James Walsh wrote the following 28 articles about Sleep Initiation and Maintenance Disorders.
 
+ Citations + Abstracts
Pages: 1 · 2
1 Review Enhancement of slow wave sleep: implications for insomnia. 2009

Walsh, James K. ·Sleep Medicine and Research Center, St Luke's Hospital and Saint Louis University, St Louis, Missouri, MO 63017, USA. James.Walsh@stlukes-stl.com ·J Clin Sleep Med · Pubmed #19998872.

ABSTRACT: -- No abstract --

2 Clinical Trial Suvorexant in Elderly Patients with Insomnia: Pooled Analyses of Data from Phase III Randomized Controlled Clinical Trials. 2017

Herring, W Joseph / Connor, Kathryn M / Snyder, Ellen / Snavely, Duane B / Zhang, Ying / Hutzelmann, Jill / Matzura-Wolfe, Deborah / Benca, Ruth M / Krystal, Andrew D / Walsh, James K / Lines, Christopher / Roth, Thomas / Michelson, David. ·Merck & Co., Inc., Kenilworth, NJ. Electronic address: william.herring@merck.com. · Merck & Co., Inc., Kenilworth, NJ. · Department of Psychiatry and Human Behavior, School of Medicine, University of California-Irvine, Irvine, CA. · Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC. · Sleep Medicine and Research Center, St. Luke's Hospital, St. Louis, MO. · Henry Ford Hospital Sleep Center, Detroit, MI. ·Am J Geriatr Psychiatry · Pubmed #28427826.

ABSTRACT: OBJECTIVE: Suvorexant is an orexin receptor antagonist approved for treating insomnia at doses of 10-20 mg. Previously reported phase III results showed that suvorexant was effective and well-tolerated in a combined-age population (elderly and nonelderly adults). The present analysis evaluated the clinical profile of suvorexant specifically in the elderly. METHODS: Prespecified subgroup analyses of pooled 3-month data from two (efficacy) and three (safety) randomized, double-blind, placebo-controlled, parallel-group trials. In each trial, elderly (≥65 years) patients with insomnia were randomized to suvorexant 30 mg, suvorexant 15 mg, and placebo. By design, fewer patients were randomized to 15 mg. Patient-reported and polysomnographic (subset of patients) sleep maintenance and onset endpoints were measured. RESULTS: Suvorexant 30 mg (N = 319) was effective compared with placebo (N = 318) on patient-reported and polysomnographic sleep maintenance, and onset endpoints at Night 1 (polysomnographic endpoints)/Week 1 (patient-reported endpoints), Month 1, and Month 3. Suvorexant 15 mg (N = 202 treated) was also effective across these measures, although the onset effect was less evident at later time points. The percentages of patients discontinuing because of adverse events over 3 months were 6.4% for 30 mg (N = 627 treated), 3.5% for 15 mg (N = 202 treated), and 5.5% for placebo (N = 469 treated). Somnolence was the most common adverse event (8.8% for 30 mg, 5.4% for 15 mg, 3.2% for placebo). CONCLUSION: Suvorexant generally improved sleep maintenance and onset over 3 months of nightly treatment and was well-tolerated in elderly patients with insomnia (clinicaltrials.gov; NCT01097616, NCT01097629, NCT01021813).

3 Clinical Trial Clinical profile of suvorexant for the treatment of insomnia over 3 months in women and men: subgroup analysis of pooled phase-3 data. 2017

Herring, W Joseph / Connor, Kathryn M / Snyder, Ellen / Snavely, Duane B / Zhang, Ying / Hutzelmann, Jill / Matzura-Wolfe, Deborah / Benca, Ruth M / Krystal, Andrew D / Walsh, James K / Lines, Christopher / Roth, Thomas / Michelson, David. ·Merck & Co., Inc., Kenilworth, NJ, USA. william_herring@merck.com. · Merck & Co., Inc., UG 4C-13, PO Box 1000, North Wales, PA, 19454-1099, USA. william_herring@merck.com. · Merck & Co., Inc., Kenilworth, NJ, USA. · Department of Psychiatry and Human Behavior, University of California-Irvine, Irvine, CA, USA. · Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA. · Sleep Medicine and Research Center, St., Luke's Hospital, St. Louis, MO, USA. · Henry Ford Hospital Sleep Center, Detroit, MI, USA. ·Psychopharmacology (Berl) · Pubmed #28265715.

ABSTRACT: RATIONALE: Sex-related differences in the clinical profiles of some insomnia medications have been previously reported. OBJECTIVE: To evaluate the clinical profile of suvorexant, a novel orexin receptor antagonist approved for treating insomnia at doses up to 20 mg, by sex subgroups. METHODS: Efficacy analyses by sex were based on pooled data from two similar phase 3, randomized, double-blind, placebo-controlled, 3-month trials in elderly (≥65 years) and non-elderly (18-64 years) insomnia patients. Two age-adjusted (non-elderly/elderly) dose regimes of 40/30 and 20/15 mg were evaluated, with fewer patients assigned to 20/15 mg. Efficacy was assessed by patient-reported outcomes (N = 1264 women, 707 men) and by polysomnography endpoints in ~75% of patients. Safety analyses by sex (N = 1744 women, 1065 men) included pooled data from the two 3-month trials plus 3-month data from a safety trial of 40/30 mg. RESULTS: The sex subgroup efficacy analyses mirrored the improvements seen for suvorexant 40/30 and 20/15 mg over placebo on patient-reported outcomes and polysomnography sleep maintenance and onset endpoints in the primary analyses; 95% CIs excluded zero in favor of suvorexant for most endpoints in both sexes, and similar efficacy was observed between sexes (95% CIs overlapped). Suvorexant was well-tolerated in women and men, although women in all treatment groups (including placebo) reported more adverse events than men. The most frequent adverse event was somnolence (women: 11.1% for 40/30 mg, 8.5% for 20/15 mg, 2.3% for placebo; men: 10.1% for 40/30 mg, 3.4% for 20/15 mg, 4.2% for placebo). CONCLUSION: Suvorexant was generally effective and well-tolerated in both women and men with insomnia. ClinicalTrials.gov trial registration numbers: NCT01097616, NCT01097629, NCT01021813.

4 Clinical Trial Suvorexant in Patients with Insomnia: Pooled Analyses of Three-Month Data from Phase-3 Randomized Controlled Clinical Trials. 2016

Herring, W Joseph / Connor, Kathleen M / Snyder, Ellen / Snavely, Duane B / Zhang, Ying / Hutzelmann, Jill / Matzura-Wolfe, Deborah / Benca, Ruth M / Krystal, Andrew D / Walsh, James K / Lines, Christopher / Roth, Thomas / Michelson, David. ·Merck & Co., Inc., Kenilworth, NJ. · University of Wisconsin, Madison, WI. · Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC. · Sleep Medicine and Research Center, St. Luke's Hospital, St. Louis, MO. · Henry Ford Hospital Sleep Center, Detroit, MI. ·J Clin Sleep Med · Pubmed #27397664.

ABSTRACT: STUDY OBJECTIVES: Suvorexant is an orexin receptor antagonist approved for treating insomnia at a maximum dose of 20 mg. Phase-3 trials evaluated two age-adjusted (non-elderly/elderly) dose-regimes of 40/30 mg and 20/15 mg with the primary focus on 40/30 mg. We report here results from pooled analyses of the 20/15 mg dose-regime, which was evaluated as a secondary objective in the trials. METHODS: Prespecified analysis of pooled data from two identical randomized, double-blind, placebo-controlled, parallel-group, 3-month trials in non-elderly (18-64 years) and elderly (≥ 65 years) patients with insomnia. Patients were randomized to suvorexant 20/15 mg (non-elderly/elderly), suvorexant 40/30 mg (non-elderly/elderly), or placebo; by design, fewer patients were randomized to 20/15 mg. Efficacy was assessed by self-reported and polysomnography (PSG; subset of patients) sleep maintenance and onset endpoints. RESULTS: Suvorexant 20/15 mg (N = 493 treated) was effective compared to placebo (N = 767 treated) on patient-reported and PSG sleep maintenance and onset endpoints at Night-1 (PSG endpoints) / Week-1 (subjective endpoints), Month-1 and Month-3, except for effects on PSG sleep onset at Month-3. Suvorexant 20/15 mg was generally well tolerated, with 3% of patients discontinuing due to adverse events over 3 months vs. 5.2% on placebo. Somnolence was the most common adverse event (6.7% vs. 3.3% for placebo). There was no systematic evidence of rebound or withdrawal signs or symptoms when suvorexant was discontinued after 3 months of nightly use. CONCLUSIONS: Suvorexant 20/15 mg improved sleep onset and maintenance over 3 months of nightly treatment and was generally safe and well tolerated. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov trial registration numbers: NCT01097616, NCT01097629.

5 Clinical Trial Suvorexant in Patients With Insomnia: Results From Two 3-Month Randomized Controlled Clinical Trials. 2016

Herring, W Joseph / Connor, Kathryn M / Ivgy-May, Neely / Snyder, Ellen / Liu, Ken / Snavely, Duane B / Krystal, Andrew D / Walsh, James K / Benca, Ruth M / Rosenberg, Russell / Sangal, R Bart / Budd, Kerry / Hutzelmann, Jill / Leibensperger, Heather / Froman, Samar / Lines, Christopher / Roth, Thomas / Michelson, David. ·Merck Sharp & Dohme Corporation, Whitehouse Station, New Jersey. Electronic address: william_herring@merck.com. · Merck Sharp & Dohme Corporation, Whitehouse Station, New Jersey. · Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, North Carolina. · Sleep Medicine and Research Center, St. Luke's Hospital, St. Louis, Missouri. · University of Wisconsin, Madison, Wisconsin. · Atlanta Sleep Medicine Clinic, Atlanta, Georgia. · Sleep Disorders Institute & Attention Disorders Institute, Oakland University William Beaumont School of Medicine, Sterling Heights. · Henry Ford Hospital Sleep Center, Detroit, Michigan. ·Biol Psychiatry · Pubmed #25526970.

ABSTRACT: BACKGROUND: Suvorexant is an orexin receptor antagonist for treatment of insomnia. We report results from two pivotal phase 3 trials. METHODS: Two randomized, double-blind, placebo-controlled, parallel-group, 3-month trials in nonelderly (18-64 years) and elderly (≥65 years) patients with insomnia. Suvorexant doses of 40/30 mg (nonelderly/elderly) and 20/15 mg (nonelderly/elderly) were evaluated. The primary focus was 40/30 mg, with fewer patients randomized to 20/15 mg. There was an optional 3-month double-blind extension in trial 1. Each trial included a 1-week, randomized, double-blind run-out after double-blind treatment to assess withdrawal/rebound. Efficacy was assessed at week 1, month 1, and month 3 by patient-reported subjective total sleep time and time to sleep onset and in a subset of patients at night 1, month 1, and month 3 by polysomnography end points of wakefulness after persistent sleep onset and latency to onset of persistent sleep (LPS). One thousand twenty-one patients were randomized in trial 1 and 1019 patients in trial 2. RESULTS: Suvorexant 40/30 mg was superior to placebo on all subjective and polysomnography end points at night 1/week 1, month 1, and month 3 in both trials, except for LPS at month 3 in trial 2. Suvorexant 20/15 mg was superior to placebo on subjective total sleep time and wakefulness after persistent sleep onset at night 1/week 1, month 1, and month 3 in both trials and at most individual time points for subjective time to sleep onset and LPS in each trial. Both doses of suvorexant were generally well tolerated, with <5% of patients discontinuing due to adverse events over 3 months. The results did not suggest the emergence of marked rebound or withdrawal signs or symptoms when suvorexant was discontinued. CONCLUSIONS: Suvorexant improved sleep onset and maintenance over 3 months of nightly treatment and was generally safe and well tolerated.

6 Clinical Trial Safety and efficacy of suvorexant during 1-year treatment of insomnia with subsequent abrupt treatment discontinuation: a phase 3 randomised, double-blind, placebo-controlled trial. 2014

Michelson, David / Snyder, Ellen / Paradis, Erin / Chengan-Liu, Mary / Snavely, Duane B / Hutzelmann, Jill / Walsh, James K / Krystal, Andrew D / Benca, Ruth M / Cohn, Martin / Lines, Christopher / Roth, Thomas / Herring, W Joseph. ·Merck & Co Inc, Whitehouse Station, NJ, USA. Electronic address: david_michelson@merck.com. · Merck & Co Inc, Whitehouse Station, NJ, USA. · Sleep Medicine and Research Center, St Luke's Hospital, St Louis, MO, USA. · Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA. · University of Wisconsin, Madison, WI, USA. · Omnitrials, Naples, FL, USA. · Henry Ford Hospital Sleep Center, Detroit, MI, USA. ·Lancet Neurol · Pubmed #24680372.

ABSTRACT: BACKGROUND: Suvorexant (MK-4305) is an orexin receptor antagonist shown to be efficacious for insomnia over 3 months. We aimed to assess its clinical profile during and after 1 year of treatment. METHODS: We did a randomised, placebo-controlled, parallel-group trial at 106 investigational centres in the Americas, Australia, Europe, and South Africa from December, 2009, to August, 2011. Patients aged 18 years or older with primary insomnia by DSM-IV-TR criteria were assigned using a computer-generated randomised allocation schedule to receive nightly suvorexant (40 mg for patients younger than 65 years, 30 mg for patients aged 65 years or older) or placebo at a 2:1 ratio for 1 year with a subsequent 2-month randomised discontinuation phase in which patients on suvorexant either continued suvorexant or were abruptly switched to placebo while patients on placebo remained on placebo. Treatment assignment was masked from patients and investigators. The primary objective was to assess the safety and tolerability of suvorexant for up to 1 year. Secondary objectives were to assess the efficacy of suvorexant for improving patient-reported subjective total sleep time (sTST) and time to sleep onset (sTSO) over the first month of treatment. Efficacy endpoints over the first month were assessed with a mixed model with terms for baseline value of the response variable, age, sex, region, treatment, time, and treatment by time interaction. This trial is registered with ClinicalTrials.gov, number NCT01021813. FINDINGS: 322 (62%) of 522 patients randomly assigned to receive suvorexant and 162 (63%) of 259 assigned to receive placebo completed the 1-year phase. Over 1 year, 362 (69%) of 521 patients treated with suvorexant experienced any adverse events compared with 164 (64%) of 258 treated with placebo. Serious adverse events were recorded in 27 patients (5%) who received suvorexant and 17 (7%) who received placebo. The most common adverse event, somnolence, was reported for 69 patients (13%) who received suvorexant and seven (3%) who received placebo. At month 1, suvorexant (517 patients in the efficacy population) showed greater efficacy than placebo (254 in the efficacy population) in improving sTST (38·7 min vs 16·0 min; difference 22·7, 95% CI 16·4 to 29·0; p<0·0001) and sTSO (-18·0 min vs -8·4 min, difference -9·5, -14·6 to -4·5; p=0·0002). INTERPRETATION: Our findings show that suvorexant was generally safe and well tolerated over 1 year of nightly treatment in patients with insomnia, with efficacy noted for subjective measures of sleep onset and maintenance. FUNDING: Merck & Co Inc.

7 Clinical Trial The partial positive allosteric GABA(A) receptor modulator EVT 201 is efficacious and safe in the treatment of adult primary insomnia patients. 2009

Walsh, James K / Thacker, Steve / Knowles, Lisa J / Tasker, Tim / Hunneyball, Ian M. ·Sleep Medicine and Research Center, St. Luke's Hospital, 232 S. Woods Mill Road, Chesterfield, MO 63017, USA. james.walsh@stlukes-stl.com ·Sleep Med · Pubmed #19345644.

ABSTRACT: OBJECTIVE: To evaluate polysomnographic (PSG) and self-reported measures of the efficacy and safety of EVT 201 in patients with primary insomnia. PATIENTS AND METHODS: Following clinical and PSG screening, 75 patients (mean age: 45.1+/-11.2 y; 50 f, 25 m) meeting DSM-IV criteria for primary insomnia entered this crossover study and were randomly assigned to double-blind treatment sequences of 1.5 mg or 2.5 mg EVT 201, or placebo using a balanced Latin square design. For each study condition study medication was administered on two consecutive nights and PSG and self-reported data were collected. Safety assessments included physical examination, clinical laboratory measures, electrocardiogram, documentation of adverse events, and the digit symbol substitution test (DSST) and self-reported sleepiness/alertness ratings to detect residual sedation. Data were collected at five US sleep laboratories. Efficacy analyses were performed for the 67 patients completing the study. Safety analyses included all 75 randomized patients. RESULTS: On PSG measures compared to placebo, EVT 201 1.5 mg and 2.5 mg increased total sleep time (TST; 33.1, 45.0 min; both p<0.0001), reduced wake after sleep onset (WASO; -16.7, -25.7 min; both p<0.0001), reduced latency to persistent sleep (LPS; -17.0, -20.7 min; both p<0.0001), and reduced the number of awakenings (-1.2, -2.6; both p<0.0001). Significant reduction of wake time was seen with 1.5 mg during each of the first three quarters of the night (p<0.0001-0.002), and with 2.5 mg in all four quarters (p<0.0001-0.0005). Both doses also improved all key self-reported measures of sleep including total sleep time (rTST; 51.9, 51.1 min; both p<0.0001), wake after sleep onset (rWASO; -29.3, -29.6 min; both p<0.0001), sleep latency (rSL; -24.0 min, p<0.004; -25.1 min, p<0.0002), and number of awakenings (rNAW; -1.1, -1.2; both p<0.0001). Sleep quality was also improved by both doses. Self-rated sleepiness in the morning did not differ from placebo for either dose; however, there was a small negative effect on the DSST for both doses. Both doses had similar effects on sleep architecture including an increase in Stage 2 sleep and REM latency and a small, but significant decrease in REM (REM -5.7, -8.3 min; p=0.0175, p=0.0006). No effect on other sleep architecture parameters, including SWS, was seen. EVT 201 was well tolerated. No serious or unexpected adverse events were reported. CONCLUSION: This first study of EVT 201 in adult patients with primary insomnia demonstrated improved measures of sleep onset and sleep maintenance, including during the third and fourth quarters of the night. Adverse events were infrequent and all were mild to moderate in severity.

8 Article Dual Orexin Receptor Antagonist, Almorexant, in Elderly Patients With Primary Insomnia: A Randomized, Controlled Study. 2017

Roth, Thomas / Black, Jed / Cluydts, Raymond / Charef, Pascal / Cavallaro, Marzia / Kramer, Fabrice / Zammit, Gary / Walsh, James. ·Thomas Roth Sleep Disorders and Research Center, Detroit, MI. · Actelion Pharmaceuticals Ltd, Allschwil, Switzerland. · Center for Sleep Research and Medicine, Stanford, CA. · Multidisciplinary Sleep Disorders Centre, University Hospital Antwerp, Antwerp, Belgium. · Clinilabs, New York, NY. · Sleep Medicine and Research Center, St. Luke's Hospital, Chesterfield, MO. ·Sleep · Pubmed #28364509.

ABSTRACT: Objective: Sleep laboratory study to determine the dose-related efficacy and safety of almorexant in elderly patients with primary chronic insomnia. Methods: Patients aged ≥65 years with primary insomnia were enrolled into a prospective, randomized, double-blind, placebo-controlled, multicenter dose-finding study with a five-period, five-way Latin square cross-over design. Patients were randomized to one of 10 unique sequences of two-night treatment with oral almorexant 25, 50, 100, or 200 mg capsules, or matching placebo. The primary efficacy endpoint was polysomnography (PSG)-determined mean wake time after sleep onset (WASO). Secondary and exploratory efficacy endpoints were also assessed. Results: 112 patients were randomized (mean [SD] age 72.1 [5.0] years; 69.9% female). Significant, dose-related improvements (reductions) in mean WASO were observed with almorexant. Least-squares mean (95% CI) treatment effects in the almorexant 200, 100, 50, and 25 mg dose groups versus placebo were -46.5 minutes (-53.0, -39.9; p < .0001), -31.4 minutes (-38.0, -24.9; p < .0001), -19.2 minutes (-25.7, -12.6; p < .0001), and -10.4 minutes (-17.0, -3.9; p = .0018), respectively. Mean total sleep time was significantly increased with each almorexant dose (mean increases versus placebo ranged 55.1-14.3 minutes; p < .0001 for each dose). Latency to persistent sleep was statistically significantly reduced only with almorexant 200 mg versus placebo (mean [95% CI] treatment effect -10.2 minutes, [-15.4, -5.0]; p = .0001). No unexpected safety concerns were identified. Adverse events were similar between all almorexant dose groups and placebo. Conclusions: Two-night oral administration of almorexant was effective and well tolerated in treating primary insomnia in elderly patients.

9 Article Esmirtazapine in non-elderly adult patients with primary insomnia: efficacy and safety from a 2-week randomized outpatient trial. 2015

Ivgy-May, Neely / Roth, Thomas / Ruwe, Frank / Walsh, James. ·Merck & Co., Inc., 2000 Galloping Hill Road Kenilworth, NJ 07033, USA. Electronic address: mayneely@gmail.com. · Henry Ford Hospital, 2799 West Grand Boulevard, Detroit, MI 48202, USA. · MSD, Postbus 20, Oss 5340 BH, The Netherlands. · St. Luke's Hospital, 232 South Woods Mill Road, Chesterfield, MO 63017, USA. ·Sleep Med · Pubmed #26047890.

ABSTRACT: BACKGROUND: Esmirtazapine (Org 50081), a high-affinity antagonist at 5-HT2A and H1 receptors, was assessed for its hypnotic efficacy. METHODS: In this double-blind, randomized study, non-elderly patients with primary insomnia (but otherwise healthy) were treated with esmirtazapine (1.5, 3.0, or 4.5 mg) or placebo for two weeks. The primary end point was patient-reported total sleep time (TST); other patient-reported end points included sleep latency (SL), wake time after sleep onset (WASO), number of awakenings, sleep quality, and satisfaction with sleep duration. Measures to assess the potential adverse effects of treatment included morning alertness, daytime function/napping, and rebound insomnia during a single-blind placebo run-out week after treatment ended. Adverse events (AEs) were also assessed. RESULTS: Overall, 526 patients were randomized and 463 (88%) completed treatment. All esmirtazapine doses significantly improved TST, SL, sleep quality, and satisfaction with sleep duration versus placebo. Relative to placebo, TST was increased by 30-40 min and SL decreased by ~12 min for all doses. The highest dose (4.5 mg) also significantly reduced WASO and number of awakenings. Across doses, AEs occurred in 25.5-32.8% of patients, compared with 20.7% with placebo. The most common AE was somnolence (~10% for esmirtazapine and 2% for placebo). The incidence of AEs leading to discontinuation was low (≤7%), and there were no serious drug-related AEs. Finally, there was no evidence of a rebound insomnia after discontinuation of esmirtazapine. CONCLUSIONS: Two weeks of treatment with esmirtazapine consistently and significantly improved patient-reported sleep parameters, and it was well tolerated in patients with primary insomnia.

10 Article The associations of insomnia with costly workplace accidents and errors: results from the America Insomnia Survey. 2012

Shahly, Victoria / Berglund, Patricia A / Coulouvrat, Catherine / Fitzgerald, Timothy / Hajak, Goeran / Roth, Thomas / Shillington, Alicia C / Stephenson, Judith J / Walsh, James K / Kessler, Ronald C. ·Department of Health Care Policy, Harvard Medical School, Boston, MA 02115, USA. ·Arch Gen Psychiatry · Pubmed #23026955.

ABSTRACT: CONTEXT: Insomnia is a common and seriously impairing condition that often goes unrecognized. OBJECTIVES: To examine associations of broadly defined insomnia (ie, meeting inclusion criteria for a diagnosis from International Statistical Classification of Diseases, 10th Revision, DSM-IV, or Research Diagnostic Criteria/International Classification of Sleep Disorders, Second Edition) with costly workplace accidents and errors after excluding other chronic conditions among workers in the America Insomnia Survey (AIS). DESIGN/SETTING: A national cross-sectional telephone survey (65.0% cooperation rate) of commercially insured health plan members selected from the more than 34 million in the HealthCore Integrated Research Database. PARTICIPANTS: Four thousand nine hundred ninety-one employed AIS respondents. MAIN OUTCOME MEASURES: Costly workplace accidents or errors in the 12 months before the AIS interview were assessed with one question about workplace accidents "that either caused damage or work disruption with a value of $500 or more" and another about other mistakes "that cost your company $500 or more." RESULTS: Current insomnia with duration of at least 12 months was assessed with the Brief Insomnia Questionnaire, a validated (area under the receiver operating characteristic curve, 0.86 compared with diagnoses based on blinded clinical reappraisal interviews), fully structured diagnostic interview. Eighteen other chronic conditions were assessed with medical/pharmacy claims records and validated self-report scales. Insomnia had a significant odds ratio with workplace accidents and/or errors controlled for other chronic conditions (1.4). The odds ratio did not vary significantly with respondent age, sex, educational level, or comorbidity. The average costs of insomnia-related accidents and errors ($32 062) were significantly higher than those of other accidents and errors ($21 914). Simulations estimated that insomnia was associated with 7.2% of all costly workplace accidents and errors and 23.7% of all the costs of these incidents. These proportions are higher than for any other chronic condition, with annualized US population projections of 274 000 costly insomnia-related workplace accidents and errors having a combined value of US $31.1 billion. CONCLUSION: Effectiveness trials are needed to determine whether expanded screening, outreach, and treatment of workers with insomnia would yield a positive return on investment for employers.

11 Article Insomnia, comorbidity, and risk of injury among insured Americans: results from the America Insomnia Survey. 2012

Kessler, Ronald C / Berglund, Patricia A / Coulouvrat, Catherine / Fitzgerald, Timothy / Hajak, Goeran / Roth, Thomas / Shahly, Victoria / Shillington, Alicia C / Stephenson, Judith J / Walsh, James K. ·Department of Health Care Policy, Harvard Medical School, Boston, MA 02115, USA. ncs@hcp.med.harvard.edu ·Sleep · Pubmed #22654202.

ABSTRACT: STUDY OBJECTIVES: To estimate associations of broadly defined insomnia (i.e., meeting inclusion criteria for International Classification of Diseases, Tenth Revision (ICD-10), Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), or Research Diagnostic Criteria/International Classification of Sleep Disorders, Second Edition (RDC/ICSD-2) diagnosis) with workplace/nonworkplace injuries controlling for comorbid conditions among workers in the America Insomnia Survey (AIS). DESIGN/SETTING: Cross-sectional telephone survey. PARTICIPANTS: National sample of 4,991 employed health plan subscribers (age 18 yr and older). INTERVENTIONS: None. MEASUREMENTS AND RESULTS: Broadly defined insomnia with duration of at least 12 mo was assessed with the Brief Insomnia Questionnaire (BIQ). Injuries in the 12 mo before interview were assessed with a standard self-report measure of injuries causing role impairment or requiring medical attention. Eighteen comorbid condition clusters were assessed with medical/pharmacy claims records and self-reports. Insomnia had significant gross associations (odds ratios, ORs) with both workplace and nonworkplace injuries (OR 2.0 and 1.5, respectively) in logistic regression analyses before controlling for comorbid conditions. The significant population attributable risk proportions (PARPs) of total injuries with insomnia was 4.6% after controlling for comorbid conditions. Only 2 other conditions had PARPs exceeding those of insomnia. The associations of insomnia with injuries did not vary significantly with worker age, sex, or education, but did vary significantly with comorbid conditions. Specifically, insomnia was significantly associated with workplace and nonworkplace injuries (OR 1.8 and 1.5, respectively) among workers having no comorbid conditions, with workplace but not nonworkplace injuries (OR 1.8 and 1.2, respectively) among workers having 1 comorbid condition, and with neither workplace nor nonworkplace injuries (OR 0.9 and 1.0, respectively) among workers having 2 or more comorbid conditions. CONCLUSIONS: The associations of insomnia with injuries vary with comorbid conditions in ways that could have important implications for targeting workplace interventions.

12 Article Chronic insomnia, quality-of-life, and utility scores: comparison with good sleepers in a cross-sectional international survey. 2012

Léger, Damien / Morin, Charles M / Uchiyama, Makoto / Hakimi, Zalmaï / Cure, Sandrine / Walsh, James K. ·Université Paris Descartes, Sorbonne Paris Cité, APHP, Hôtel Dieu de Paris, Centre du Sommeil et de la Vigilance, Paris, France. damien.leger@htd.aphp.fr ·Sleep Med · Pubmed #22093806.

ABSTRACT: BACKGROUND: Chronic insomnia has a recognized impact on health-related quality-of-life (HRQoL) but data on utility scores across countries are lacking. The objective of the present study was to assess health related quality of life (HRQoL) and utility scores in individuals from three different countries (USA, France, and Japan), comparing sufferers of chronic insomnia to good sleepers. METHODS: A cross-sectional survey (SLEEPI-i) of 4067 persons in the US (n=1298; 478 good sleepers and 820 patients with insomnia), France (n=1858; 998 good sleepers and 860 patients with insomnia) and Japan (n=911; 506 good sleepers and 405 patients with insomnia). Enrollment and data collection using consumer panels were web-based in the US and France, and gathered via a postal survey in Japan. People with chronic insomnia (>6 months) were selected based on Insomnia Severity Index scores (ISI). Severity of insomnia was assessed using the ISI score and HRQoL was assessed using the self-administered Short-Form SF-36 Health Survey. Utility scores were derived using the algorithm developed by Brazier et al. Multivariate analyses were used to adjust for potential confounding factors. RESULTS: In all countries, people with chronic insomnia (40% treated) reported lower SF-36 scores in each of eight domains compared with good sleepers (P<.0001). Chronic insomnia was associated with significantly lower utility scores compared with good sleepers (mean scores 0.63 versus 0.72 in the US, 0.57 versus 0.67 in France, and 0.67 versus 0.77 in Japan, P<.0001). CONCLUSIONS: This survey suggests that chronic insomnia is associated with significant impairment of HRQoL and decreased utilities across the different geographical regions studied.

13 Article EEG power spectra response to a 4-h phase advance and gaboxadol treatment in 822 men and women. 2011

Ma, Junshui / Dijk, Derk-Jan / Svetnik, Vladimir / Tymofyeyev, Yevgen / Ray, Shubhankar / Walsh, James K / Deacon, Steve. ·Merck Research Laboratories, Biometrics Research, Rahway, NJ, USA. ·J Clin Sleep Med · Pubmed #22003345.

ABSTRACT: STUDY OBJECTIVE: To explore the effect of gaboxadol on NREM EEG in transient insomnia using power spectral analysis and evaluate the response between men and women. METHODS: This was a randomized, double-blind, 3-way, parallel-group transient insomnia study in 22 sleep laboratories. After a baseline night (N1), subjects underwent a 4-h phase-advance of their habitual sleep time the following night (N2). Healthy subjects aged 18-64 y were given single-blind placebo on N1 followed by double-blind treatment on N2 (gaboxadol 10 mg [n = 271], 15 mg [n = 274], or placebo [n = 277]) RESULTS: At baseline, women showed significantly greater values in low frequency activity (< 10 Hz) and in high spindle/low beta frequency activity (14-18 Hz) compared to men. During the phase advance (placebo N2-baseline N1), there was a significant increase in power within the high spindle/low beta frequency range (15-17 Hz) and a significant reduction in beta activity (20-32 Hz), which was greater in women than men. Gaboxadol induced a significant (dose-related) increase in low frequencies (< 8 Hz) and a significant (dose-related) decrease within the alpha/spindle range (11-12 Hz). The effect was dependent upon sex, with a greater magnitude of effect observed in women than men. CONCLUSION: Gaboxadol shows a characteristic NREM EEG spectral profile in a model of transient insomnia. Men and women show clear differences in NREM EEG activity at baseline, to gaboxadol treatment and to phase-shifts in habitual sleep/wake times. The exact mechanisms underlying the sex differences remain unclear, but sex is an important variable in studies evaluating sleep and gaboxadol. TRIAL REGISTRY INFORMATION: TRIAL REGISTRY: www.clinicaltrials.gov, study identifier: NCT00102167.

14 Article Days-out-of-role associated with insomnia and comorbid conditions in the America Insomnia Survey. 2011

Hajak, Goeran / Petukhova, Maria / Lakoma, Matthew D / Coulouvrat, Catherine / Roth, Thomas / Sampson, Nancy A / Shahly, Victoria / Shillington, Alicia C / Stephenson, Judith J / Walsh, James K / Kessler, Ronald C. ·Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, Social Foundation Bamberg, Teaching Hospital of the University of Erlangen, Bamberg, Germany. ·Biol Psychiatry · Pubmed #21962491.

ABSTRACT: BACKGROUND: Insomnia is highly prevalent and impairing but also highly comorbid with other chronic physical/mental disorders. Population-based research has yet to differentiate the role impairments uniquely associated with insomnia per se from those due to comorbidity. METHODS: A representative sample of 6791 adult subscribers to a large national US commercial health plan was surveyed by telephone about sleep and health. Twenty-one conditions previously found to be comorbid with insomnia were assessed with medical/pharmacy claims data and validated self-report scales. The Brief Insomnia Questionnaire, a fully structured, clinically validated scale, generated insomnia diagnoses according to inclusion criteria of DSM-IV-TR, ICD-10, and Research Diagnostic Criteria/International Classification of Sleep Disorders: Diagnostic and Coding Manual, Second Edition. The World Health Organization Disability Assessment Schedule-II assessed number of days in the past 30 when health problems prevented respondents from conducting their usual daily activities. Regression analyses estimated associations of insomnia with days-out-of-role controlling comorbidity. RESULTS: Insomnia was significantly associated with days-out-of-role (.90 days/month) in a gross model. The association was reduced when controls were introduced for comorbidity (.42 days/month). This net association did not vary with number or type of comorbid conditions but was confined to respondents 35+ years of age. Insomnia was one of the most important conditions studied not only at the individual level, where it was associated with among the largest mean days-out-of-role, but also at the aggregate level, where it was associated with 13.6% of all days-out-of-role. CONCLUSIONS: Insomnia has a strong net association with days-out-of-role that does not vary as a function of comorbidity.

15 Article Insomnia and the performance of US workers: results from the America insomnia survey. 2011

Kessler, Ronald C / Berglund, Patricia A / Coulouvrat, Catherine / Hajak, Goeran / Roth, Thomas / Shahly, Victoria / Shillington, Alicia C / Stephenson, Judith J / Walsh, James K. ·Department of Health Care Policy, Harvard Medical School, Boston, MA 02115, USA. kessler@hcp.med.harvard.edu ·Sleep · Pubmed #21886353.

ABSTRACT: STUDY OBJECTIVES: To estimate the prevalence and associations of broadly defined (i.e., meeting full ICD-10, DSM-IV, or RDC/ICSD-2 inclusion criteria) insomnia with work performance net of comorbid conditions in the America Insomnia Survey (AIS). DESIGN/SETTING: Cross-sectional telephone survey. PARTICIPANTS: National sample of 7,428 employed health plan subscribers (ages 18+). INTERVENTIONS: None. MEASUREMENTS AND RESULTS: Broadly defined insomnia was assessed with the Brief Insomnia Questionnaire (BIQ). Work absenteeism and presenteeism (low on-the-job work performance defined in the metric of lost workday equivalents) were assessed with the WHO Health and Work Performance Questionnaire (HPQ). Regression analysis examined associations between insomnia and HPQ scores controlling 26 comorbid conditions based on self-report and medical/pharmacy claims records. The estimated prevalence of insomnia was 23.2%. Insomnia was significantly associated with lost work performance due to presenteeism (χ² (1) = 39.5, P < 0.001) but not absenteeism (χ² (1) = 3.2, P = 0.07), with an annualized individual-level association of insomnia with presenteeism equivalent to 11.3 days of lost work performance. This estimate decreased to 7.8 days when controls were introduced for comorbid conditions. The individual-level human capital value of this net estimate was $2,280. If we provisionally assume these estimates generalize to the total US workforce, they are equivalent to annualized population-level estimates of 252.7 days and $63.2 billion. CONCLUSIONS: Insomnia is associated with substantial workplace costs. Although experimental studies suggest some of these costs could be recovered with insomnia disease management programs, effectiveness trials are needed to obtain precise estimates of return-on-investment of such interventions from the employer perspective.

16 Article Nighttime insomnia symptoms and perceived health in the America Insomnia Survey (AIS). 2011

Walsh, James K / Coulouvrat, Catherine / Hajak, Goeran / Lakoma, Matthew D / Petukhova, Maria / Roth, Thomas / Sampson, Nancy A / Shahly, Victoria / Shillington, Alicia / Stephenson, Judith J / Kessler, Ronald C. ·Sleep Medicine and Research Center, St. Luke’s Hospital, St. Louis, MO, USA. ·Sleep · Pubmed #21804662.

ABSTRACT: STUDY OBJECTIVES: To explore the distribution of the 4 cardinal nighttime symptoms of insomnia-difficulty initiating sleep (DIS), difficulty maintaining sleep (DMS), early morning awakening (EMA), and nonrestorative sleep (NRS)-in a national sample of health plan members and the associations of these nighttime symptoms with sociodemographics, comorbidity, and perceived health. DESIGN/SETTING/PARTICIPANTS: Cross-sectional telephone survey of 6,791 adult respondents. INTERVENTION: None. MEASUREMENTS/RESULTS: Current insomnia was assessed using the Brief Insomnia Questionnaire (BIQ)-a fully structured validated scale generating diagnoses of insomnia using DSM-IV-TR, ICD-10, and RDC/ICSD-2 inclusion criteria. DMS (61.0%) and EMA (52.2%) were more prevalent than DIS (37.7%) and NRS (25.2%) among respondents with insomnia. Sociodemographic correlates varied significantly across the 4 symptoms. All 4 nighttime symptoms were significantly related to a wide range of comorbid physical and mental conditions. All 4 also significantly predicted decrements in perceived health both in the total sample and among respondents with insomnia after adjusting for comorbid physical and mental conditions. Joint associations of the 4 symptoms predicting perceived health were additive and related to daytime distress/impairment. Individual-level associations were strongest for NRS. At the societal level, though, where both prevalence and strength of individual-level associations were taken into consideration, DMS had the strongest associations. CONCLUSIONS: The extent to which nighttime insomnia symptoms are stable over time requires future long-term longitudinal study. Within the context of this limitation, the results suggest that core nighttime symptoms are associated with different patterns of risk and perceived health and that symptom-based subtyping might have value.

17 Article The association between insomnia severity and healthcare and productivity costs in a health plan sample. 2011

Sarsour, Khaled / Kalsekar, Anupama / Swindle, Ralph / Foley, Kathleen / Walsh, James K. ·Global Health Outcomes, Eli Lilly and Company, Lilly Corporate Center, DC 1833, Indianapolis, IN 46285, USA. Sarsour_khaled@lilly.com ·Sleep · Pubmed #21461322.

ABSTRACT: STUDY OBJECTIVES: Insomnia is a chronic condition with significant burden on health care and productivity costs. Despite this recognized burden, very few studies have examined associations between insomnia severity and healthcare and productivity costs. DESIGN: A retrospective study linking health claims data with a telephone survey of members of a health plan in the Midwestern region of the United States. PARTICIPANTS: The total healthcare costs study sample consisted of 2086 health plan members who completed the survey and who had complete health claims data. The productivity costs sample consisted of 1329 health plan members who worked for pay-a subset of the total healthcare costs sample. MEASUREMENTS: Subjects' age, gender, demographic variables, comorbidities, and total health care costs were ascertained using health claims. Insomnia severity and lost productivity related variables were assessed using telephone interview. RESULTS: Compared with the no insomnia group, mean total healthcare costs were 75% larger in the group with moderate and severe insomnia ($1323 vs. $757, P<0.05). Compared with the no insomnia group, mean lost productivity costs were 72% larger in the moderate and severe insomnia group ($1739 vs. $1013, P<0.001). Chronic medical comorbidities and psychiatric comorbidities were positively associated with health care cost. In contrast, psychiatric comorbidities were associated with lost productivity; while, medical comorbidities were not associated with lost productivity. CONCLUSIONS: Health care and lost productivity costs were consistently found to be greater in moderate and severe insomniacs compared with non-insomniacs. Factors associated with lost productivity and health care costs may be fundamentally different and may require different kinds of interventions. Future studies should focus on better understanding mechanisms linking insomnia to healthcare and productivity costs and to understanding whether developing targeted interventions will reduce these costs.

18 Article Prevalence and perceived health associated with insomnia based on DSM-IV-TR; International Statistical Classification of Diseases and Related Health Problems, Tenth Revision; and Research Diagnostic Criteria/International Classification of Sleep Disorders, Second Edition criteria: results from the America Insomnia Survey. 2011

Roth, Thomas / Coulouvrat, Catherine / Hajak, Goeran / Lakoma, Matthew D / Sampson, Nancy A / Shahly, Victoria / Shillington, Alicia C / Stephenson, Judith J / Walsh, James K / Kessler, Ronald C. ·Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan, USA. ·Biol Psychiatry · Pubmed #21195389.

ABSTRACT: BACKGROUND: Although several diagnostic systems define insomnia, little is known about the implications of using one versus another of them. METHODS: The America Insomnia Survey, an epidemiological survey of managed health care plan subscribers (n = 10,094), assessed insomnia with the Brief Insomnia Questionnaire, a clinically validated scale generating diagnoses according to DSM-IV-TR; International Statistical Classification of Diseases, Tenth Revision (ICD-10); and Research Diagnostic Criteria/International Classification of Sleep Disorders, Second Edition (RDC/ICSD-2) criteria. Regression analysis examines associations of insomnia according to the different systems with summary 12-item Short-Form Health Survey scales of perceived health and health utility. RESULTS: Insomnia prevalence estimates varied widely, from 22.1% for DSM-IV-TR to 3.9% for ICD-10 criteria. Although ICD insomnia was associated with significantly worse perceived health than DSM or RDC/ICSD insomnia, DSM-only cases also had significant decrements in perceived health. Because of its low prevalence, 66% of the population-level health disutility associated with overall insomnia and 84% of clinically relevant cases of overall insomnia were missed by ICD criteria. CONCLUSIONS: Insomnia is highly prevalent and associated with substantial decrements in perceived health. Although ICD criteria define a narrower and more severe subset of cases than DSM criteria, the fact that most health disutility associated with insomnia is missed by ICD criteria, while RDC/ICSD-only cases do not have significant decrements in perceived health, supports use of the broader DSM criteria.

19 Article Pharmacotherapy for insomnia. 2011

Feren, Stephen / Schweitzer, Paula K / Walsh, James K. ·St. John's Mercy Medical Center, Chesterfield, MO, USA. ·Handb Clin Neurol · Pubmed #21056226.

ABSTRACT: -- No abstract --

20 Article Alterations in cyclic alternating pattern associated with phase advanced sleep are differentially modulated by gaboxadol and zolpidem. 2010

Svetnik, Vladimir / Ferri, Raffaele / Ray, Shubhankar / Ma, Junshui / Walsh, James K / Snyder, Ellen / Ebert, Bjarke / Deacon, Steve. ·Merck Svetnik Laboratories, Biometrics Research, Rahway, NJ 07065, USA. vladimir_svetnik@merck.com ·Sleep · Pubmed #21102998.

ABSTRACT: OBJECTIVE: to evaluate cyclic alternating pattern (CAP) in a phase advance model of transient insomnia and the effects of gaboxadol and zolpidem. DESIGN: a randomized, double-blind, cross-over study in which habitual sleep time was advanced by 4 h. SETTING: 6 sleep research laboratories in US PARTICIPANTS: 55 healthy subjects (18-57 y) INTERVENTIONS: Gaboxadol 15 mg (GBX), zolpidem 10 mg (ZOL), and placebo (PBO). MEASUREMENTS: routine polysomnographic (PSG) measures, CAP, spectral power density, and self-reported sleep measures RESULTS: The phase advance model of transient insomnia produced significant changes in CAP parameters. Both GBX and ZOL significantly and differentially modified CAP parameters in the direction of more stable sleep. GBX brought the CAP rate in stage 1 sleep and slow wave sleep (SWS) closer to baseline levels but did not significantly change the CAP rate in stage 2. ZOL reduced the CAP rate in stage 2 to near baseline levels, whereas the CAP rate in stage 1 and SWS was reduced substantially below baseline levels. The CAP parameter A1 index (associated with SWS and sleep continuity) showed the highest correlation with self-reported sleep quality, higher than any traditional PSG, spectral, or other self-reported measures. CONCLUSION: disruptions in CAP produced by phase advanced sleep were significantly and differentially modulated by gaboxadol and zolpidem. The relative independence of CAP parameters from other electrophysiological measures of sleep, their high sensitivity to sleep disruption, and their strong association with subjective sleep quality suggest that CAP variables may serve as valuable endpoints in future insomnia research.

21 Article Reliability and validity of the brief insomnia questionnaire in the America insomnia survey. 2010

Kessler, Ronald C / Coulouvrat, Catherine / Hajak, Goeran / Lakoma, Matthew D / Roth, Thomas / Sampson, Nancy / Shahly, Victoria / Shillington, Alicia / Stephenson, Judith J / Walsh, James K / Zammit, Gary K. ·Department of Health Care Policy, Harvard Medical School, Boston, MA 02115, USA. kessler@hcp.med.harvard.edu ·Sleep · Pubmed #21102996.

ABSTRACT: STUDY OBJECTIVES: to evaluate the reliability and validity of the Brief Insomnia Questionnaire (BIQ), a fully structured questionnaire developed to diagnose insomnia according to hierarchy-free Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR), International Classification of Diseases-10 (ICD-10), and research diagnostic criteria/International Classification of Sleep Disorders-2 (RDC/ICSD-2) general criteria without organic exclusions in the America Insomnia Survey (AIS). DESIGN: probability subsamples of AIS respondents, oversampling BIQ positives, completed short-term test-retest interviews (n = 59) or clinical reappraisal interviews (n = 203) to assess BIQ reliability and validity. SETTING: the AIS is a large (n = 10,094) epidemiologic survey of the prevalence and correlates of insomnia. PARTICIPANTS: adult subscribers to a national managed healthcare plan. INTERVENTION: None MEASUREMENTS AND RESULTS: BIQ test-retest correlations were 0.47-0.94 for nature of the sleep problems (initiation, maintenance, nonrestorative sleep [NRS]), 0.72-0.95 for problem frequency, 0.66-0.88 for daytime impairment/distress, and 0.62 for duration of sleep. Good individual-level concordance was found between BIQ diagnoses and diagnoses based on expert interviews for meeting hierarchy-free inclusion criteria for diagnoses in any of the diagnostic systems, with area under the receiver operating characteristic curve (AUC, a measure of classification accuracy insensitive to disorder prevalence) of 0.86 for dichotomous classifications. The AUC increased to 0.94 when symptom-level data were added to generate continuous predicted-probability of diagnosis measures. The AUC was lower for dichotomous classifications based on RDC/ICSD-2 (0.68) and ICD-10 (0.70) than for DSM-IV-TR (0.83) criteria but increased consistently when symptom-level data were added to generate continuous predicted-probability measures of RDC/ICSD-2, ICD-10, and DSM-IV-TR diagnoses (0.92-0.95). CONCLUSIONS: these results show that the BIQ generates accurate estimates of the prevalence and correlates of hierarchy-free insomnia in the America Insomnia Survey.

22 Article Associations of nonrestorative sleep with insomnia, depression, and daytime function. 2010

Sarsour, Khaled / Van Brunt, David L / Johnston, Joseph A / Foley, Kathleen A / Morin, Charles M / Walsh, James K. ·Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA. Sarsour_Khaled@lilly.com ·Sleep Med · Pubmed #21093365.

ABSTRACT: STUDY OBJECTIVES: Nonrestorative sleep (NRS) complaints are common but associations with insomnia, daytime function or depressive symptoms are not well-established. This study aims to (1) describe insomnia related symptoms and sleep quality in those with NRS compared to those with no NRS; (2) identify the independent associations between NRS, insomnia severity, and depression; and (3) identify the association between NRS and daytime function independent of insomnia severity and depression. DESIGN: Cross sectional survey of enrollees at a health plan in the Midwestern United States. MEASUREMENT: Respondents were surveyed about the presence and frequency of NRS complaints, depression, insomnia severity and related symptoms. Multivariate regression was used to examine the study's three research aims. PARTICIPANTS: Study sample consisted of 541 subjects with NRS and 717 who reported never experiencing any NRS symptoms. RESULTS: We found a statistically significant interaction between NRS and total sleep duration such that the association between sleep duration and sleep quality was attenuated in those with NRS compared to those without NRS (b=-0.26, SE=0.07, p<0.0001). In multivariate analysis, subthreshold, moderate and severe insomnia were associated with NRS (OR [95%CI]=5.93 [4.24-8.31], 9.22 [6.15-13.83] and 6.10 [3.34-11.14], respectively). NRS was independently associated with daytime physical function, cognitive function and emotional function OR [95%CI]=2.21 [1.59-3.08], 1.90 [1.37-2.64] and 1.71 [1.23-2.36], respectively. CONCLUSION: NRS is a complex concept that should be further defined and studied in the larger context of sleep quality, other insomnia related symptoms, daytime function and depression.

23 Article Subtypes of sleep disturbance: associations among symptoms, comorbidities, treatment, and medical costs. 2010

Foley, Kathleen A / Sarsour, Khaled / Kalsekar, Anupama / Walsh, James K. ·Jefferson School of Population Health, Thomas Jefferson University, 1015 Walnut Street, Philadelphia, PA 19107, USA. kathleen.a.foley@jefferson.edu ·Behav Sleep Med · Pubmed #20352545.

ABSTRACT: Medical claims and survey data were used to evaluate patients with sleep disturbance lasting 1 year or more, and to identify subtypes of sleep disturbance using latent class analysis. Four subtypes were identified from the 1,374 patients. Subtypes differed on the number of sleep disturbance symptoms, presence of non-restorative sleep and comorbidities, degree of daytime impairment, and insomnia severity. The results from this study suggest that patient-reported symptoms of sleep disturbance, the frequency of symptoms, functional impairment, and comorbid conditions are important elements in distinguishing among groups of patients with varying degrees of sleep problems. These data provide evidence that the Insomnia Severity Index (ISI) varies accordingly with the frequency and resulting impairment of symptoms captured in the 4 clusters.

24 Article Treatment of elderly primary insomnia patients with EVT 201 improves sleep initiation, sleep maintenance, and daytime sleepiness. 2010

Walsh, James K / Salkeld, Lynette / Knowles, Lisa J / Tasker, Tim / Hunneyball, Ian M. ·Sleep Medicine and Research Center, St. Luke's Hospital, 232 S. Woods Mill Road, Chesterfield, MO 63017, United States. james.walsh@stlukes-stl.com ·Sleep Med · Pubmed #19945340.

ABSTRACT: OBJECTIVE: Two doses of EVT 201, a partial positive allosteric modulator of the GABA(A) system, were evaluated in elderly primary insomnia patients with daytime sleepiness. PATIENTS AND METHODS: Participants were 149 elderly patients with DSM-IV primary insomnia including evidence of daytime sleepiness (53 males, 96 females; mean age 71.3yrs, range 65-86yrs). A randomized, multicentre, double-blind, placebo-controlled, parallel-group design was used to assess the hypnotic efficacy of EVT 201 1.5 and 2.5mg during seven consecutive nights. Polysomnography (PSG) was performed on nights 1, 6 and 7 of treatment. Daytime assessments on Day 8 included the multiple sleep latency test (MSLT), Rey Auditory Verbal Learning Test (RAVLT), Psychomotor Vigilance Task (PVT) and the Karolinska Sleepiness Scale (KSS). The primary endpoint was total sleep time (TST) and the key secondary endpoint was mean MSLT latency. RESULTS: Compared to placebo, EVT 201 1.5 and 2.5mg increased TST (30.9, 56.4min, respectively; p=0.0001, p<0.0001); reduced wake after sleep onset (WASO; -15.2, -36.1min, respectively; p=0.014, p<0.0001); reduced latency to persistent sleep (LPS; -15.9, -19.9min, respectively; p=0.009, p=0.001). The 2.5mg dose also reduced WASO in hours 5-8 (-16.3min, p=0.001). Both doses also improved subjective sleep quality and usual subjective efficacy measures. A significantly longer mean MSLT latency was observed on Day 8 with both doses, compared to placebo (2min increase; p=0.03, both doses). The PVT, RAVLT, and POMS did not differ among treatment groups. No serious or unexpected treatment emergent adverse events were noted. CONCLUSION: EVT 201 improved PSG measures of sleep onset and sleep maintenance and significantly reduced daytime physiological sleep tendency. These findings suggest that treatment of primary insomnia in older patients has the potential to improve daytime sleepiness as well as sleep.

25 Article Association of insomnia severity and comorbid medical and psychiatric disorders in a health plan-based sample: Insomnia severity and comorbidities. 2010

Sarsour, Khaled / Morin, Charles M / Foley, Kathleen / Kalsekar, Anupama / Walsh, James K. ·Global Health Outcomes, Eli Lilly and Company, Lilly Research Laboratories, Indianapolis, IN 46285, USA. sarsourkh@lilly.com ·Sleep Med · Pubmed #19410512.

ABSTRACT: BACKGROUND: Insomnia is commonly associated with one or more comorbid illnesses. Data on the relationship between insomnia severity and comorbid disorders are still limited, especially with regard to the use of well-validated measures of insomnia severity. METHODS: A total of 2086 health plan enrollees, over-sampling for those with insomnia based on health claims, completed a telephone survey between April and June of 2006. Participants were categorized using four insomnia severity categories and compared on their administrative health claims' psychiatric and medical comorbidities. RESULTS: Controlling for age and gender, the odds ratio for having at least one psychiatric diagnosis was 5.04 (CI=3.24-7.84) for severe insomnia, 2.63 (CI=1.97-3.51) for moderate insomnia, and 1.7 (CI=1.30-2.23) for subthreshold insomnia compared with those with no insomnia. Similarly, the odds ratio for having treatment for at least one chronic disease was 2.83 (CI=1.84-4.35) for severe insomnia, 2.34 (CI=1.83-2.99) for moderate insomnia, and 1.55 (CI=1.25-1.92) for subthreshold insomnia compared with the no insomnia group. CONCLUSIONS: Increasing insomnia severity is associated with increased chronic medical and psychiatric illnesses. Further research is needed to better understand associations between insomnia severity and individual psychiatric and chronic medical comorbidities.

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