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Sleep Initiation and Maintenance Disorders: HELP
Articles by Jill Hutzelmann
Based on 7 articles published since 2008
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Between 2008 and 2019, Jill Hutzelmann wrote the following 7 articles about Sleep Initiation and Maintenance Disorders.
 
+ Citations + Abstracts
1 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).

2 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.

3 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.

4 Clinical Trial A Phase II Dose-Ranging Study Evaluating the Efficacy and Safety of the Orexin Receptor Antagonist Filorexant (MK-6096) in Patients with Primary Insomnia. 2016

Connor, Kathryn M / Mahoney, Erin / Jackson, Saheeda / Hutzelmann, Jill / Zhao, Xin / Jia, Nan / Snyder, Ellen / Snavely, Duane / Michelson, David / Roth, Thomas / Herring, W Joseph. ·Merck & Co., Inc., Kenilworth, NJ (Dr Connor, Ms Mahoney, Ms Jackson, Ms Hutzelmann, Dr Zhao, Dr Jia, Dr Snyder, Mr Snavely, Dr Michelson, and Dr Herring); Henry Ford Hospital, Detroit, MI (Dr Roth).Current affiliations: Biogen, Cambridge, MA (E.M.). Janssen Pharmaceutical Research and Development, Raritan, NJ (X.Z.). Eli Lilly and Company, Indianapolis, IN (N.J.) kathryn.connor@merck.com. · Merck & Co., Inc., Kenilworth, NJ (Dr Connor, Ms Mahoney, Ms Jackson, Ms Hutzelmann, Dr Zhao, Dr Jia, Dr Snyder, Mr Snavely, Dr Michelson, and Dr Herring); Henry Ford Hospital, Detroit, MI (Dr Roth).Current affiliations: Biogen, Cambridge, MA (E.M.). Janssen Pharmaceutical Research and Development, Raritan, NJ (X.Z.). Eli Lilly and Company, Indianapolis, IN (N.J.). ·Int J Neuropsychopharmacol · Pubmed #26979830.

ABSTRACT: BACKGROUND: Filorexant (MK-6096) is an orexin receptor antagonist; here, we evaluate the efficacy of filorexant in the treatment of insomnia in adults. METHODS: A double-blind, placebo-controlled, randomized, two 4-week-period, adaptive crossover polysomnography study was conducted at 51 sites worldwide. Patients (18 to <65 years) with insomnia received 1 of 4 doses of oral filorexant (2.5, 5, 10, 20mg) once daily at bedtime during one period and matching placebo in the other period in 1 of 8 possible treatment sequences. Polysomnography was performed on night 1 and end of week 4 of each period. The primary endpoint was sleep efficiency at night 1 and end of week 4. Secondary endpoints included wakefulness after persistent sleep onset and latency to onset of persistent sleep. RESULTS: A total of 324 patients received study treatment, 315 received ≥1 dose of placebo, and 318 ≥1 dose of filorexant (2.5mg, n=79; 5mg, n=78; 10mg, n=80; 20mg, n=81). All filorexant doses (2.5/5/10/20mg) were significantly superior to placebo in improving sleep among patients with insomnia as measured by sleep efficiency and wakefulness after persistent sleep onset on night 1 and end of week 4. The 2 higher filorexant doses (10/20mg) were also significantly more effective than placebo in improving sleep onset as measured by latency to onset of persistent sleep at night 1 and end of week 4. Filorexant was generally well tolerated. CONCLUSIONS: Orexin receptor antagonism by filorexant significantly improved sleep efficiency in nonelderly patients with insomnia. Dose-related improvements in sleep onset and maintenance outcomes were also observed with filorexant.

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 Article Orexin receptor antagonism for treatment of insomnia: a randomized clinical trial of suvorexant. 2012

Herring, W Joseph / Snyder, Ellen / Budd, Kerry / Hutzelmann, Jill / Snavely, Duane / Liu, Kenneth / Lines, Christopher / Roth, Thomas / Michelson, David. ·Merck Sharp & Dohme Corp., Whitehouse Station, NJ, USA. william.herring@merck.com ·Neurology · Pubmed #23197752.

ABSTRACT: OBJECTIVE: To assess the utility of orexin receptor antagonism as a novel approach to treating insomnia. METHODS: We evaluated suvorexant, an orexin receptor antagonist, for treating patients with primary insomnia in a randomized, double-blind, placebo-controlled, 2-period (4 weeks per period) crossover polysomnography study. Patients received suvorexant (10 mg [n = 62], 20 mg [n = 61], 40 mg [n = 59], or 80 mg [n = 61]) in one period and placebo (n = 249) in the other. Polysomnography was performed on night 1 and at the end of week 4 of each period. The coprimary efficacy end points were sleep efficiency on night 1 and end of week 4. Secondary end points were wake after sleep onset and latency to persistent sleep. RESULTS: Suvorexant showed significant (p values <0.01) dose-related improvements vs placebo on the coprimary end points of sleep efficiency at night 1 and end of week 4. Dose-related effects were also observed for sleep induction (latency to persistent sleep) and maintenance (wake after sleep onset). Suvorexant was generally well tolerated. CONCLUSIONS: The data suggest that orexin receptor antagonism offers a novel approach to treating insomnia. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that suvorexant improves sleep efficiency over 4 weeks in nonelderly adult patients with primary insomnia.