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Sleep Initiation and Maintenance Disorders: HELP
Articles by Russell P. Rosenberg
Based on 4 articles published since 2009
(Why 4 articles?)

Between 2009 and 2019, Russell Rosenberg wrote the following 4 articles about Sleep Initiation and Maintenance Disorders.
+ Citations + Abstracts
1 Clinical Trial Lemborexant, A Dual Orexin Receptor Antagonist (DORA) for the Treatment of Insomnia Disorder: Results From a Bayesian, Adaptive, Randomized, Double-Blind, Placebo-Controlled Study. 2017

Murphy, Patricia / Moline, Margaret / Mayleben, David / Rosenberg, Russell / Zammit, Gary / Pinner, Kate / Dhadda, Shobha / Hong, Quan / Giorgi, Luigi / Satlin, Andrew. ·Eisai Inc, Woodcliff Lake, New Jersey. · Community Research Inc, Cincinnati, Ohio. · NeuroTrials Research Inc, Atlanta, Georgia. · CLINILABS, Inc, New York, New York. · Eisai Ltd, Hatfield, United Kingdom. ·J Clin Sleep Med · Pubmed #29065953.

ABSTRACT: STUDY OBJECTIVES: To identify dose(s) of lemborexant that maximize insomnia treatment efficacy while minimizing next-morning residual sleepiness and evaluate lemborexant effects on polysomnography (PSG) measures (sleep efficiency [SE], latency to persistent sleep [LPS], and wake after sleep onset [WASO]) at the beginning and end of treatment. METHODS: Adults and elderly subjects with insomnia disorder per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition were enrolled in a multicenter, randomized, double-blind, placebo-controlled, Bayesian, adaptive, parallel-group study, receiving lemborexant (1, 2.5, 5, 10, 15, 25 mg) or placebo for 15 nights. Efficacy assessments included a utility function that combined efficacy (SE) and safety (residual morning sleepiness as measured by Karolinska Sleepiness Scale [KSS]), PSG measures, and sleep diary. Safety assessments included KSS, Digit Symbol Substitution Test, computerized reaction time tests, and adverse events (AEs). RESULTS: A total of 616 subjects were screened; 291 were randomized. Baseline characteristics were similar between lemborexant groups and placebo (∼63% female, median age: 49.0 years). The study was stopped for early success after the fifth interim analysis when the 15-mg dose met utility index/KSS criteria for success; 3 other doses also met the criteria. Compared with placebo, subjects showed significant improvements in SE, subjective SE, LPS, and subjective sleep onset latency at the beginning and end of treatment for lemborexant doses ≥ 5 mg ( CONCLUSIONS: Lemborexant doses ranging from 2.5-10 mg provided efficacy for the treatment of insomnia while minimizing next-morning residual sleepiness. CLINICAL TRIAL REGISTRATION: Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Bayesian Adaptive Randomization Design, Dose Response Study of the Efficacy of E2006 in Adults and Elderly Subjects With Chronic Insomnia; URL: https://clinicaltrials.gov/ct2/show/NCT01995838; Identifier: NCT01995838.

2 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.

3 Article Effects of Suvorexant, an Orexin Receptor Antagonist, on Respiration during Sleep In Patients with Obstructive Sleep Apnea. 2016

Sun, Hong / Palcza, John / Card, Deborah / Gipson, Adrianna / Rosenberg, Russell / Kryger, Meir / Lines, Christopher / Wagner, John A / Troyer, Matthew D. ·Merck & Co., Inc., Kenilworth, NJ. · NeuroTrials Research, Atlanta, GA. · Yale School of Medicine, New Haven, CT. ·J Clin Sleep Med · Pubmed #26194728.

ABSTRACT: STUDY OBJECTIVES: To investigate the respiratory effects of suvorexant, an orexin receptor antagonist for treating insomnia, in patients with obstructive sleep apnea (OSA). METHODS: This was a randomized, double-blind, placebo-controlled, 2-period (4 days per period), crossover, sleep laboratory study. Twenty-six patients aged 18-65 years with mild (apnea-hypopnea index [AHI] ≥ 5 and < 15) to moderate (AHI ≥ 15 and < 30) OSA were randomized to receive suvorexant 40 mg or placebo in period-1 and then crossed over to the other treatment in period-2. Breathing during sleep was measured by AHI (primary endpoint) and oxygen saturation assessed by pulse oximetry (SpO2, secondary endpoint). The study was powered to rule out a mean increase in AHI between suvorexant and placebo of 5 or greater on Day 4. RESULTS: There was a small increase in mean AHI (2.66) in OSA patients after multiple doses of suvorexant relative to placebo, with the upper 90% CI bound slightly exceeding 5.00 (0.22, 5.09). No increase in mean AHI was observed after a single dose of suvorexant versus placebo (mean difference = -0.47 [-3.20, 2.26]), and there was no treatment effect on mean SpO2 during total sleep time after single or multiple doses (Day 1: mean difference = -0.04 [-0.49, 0.42]; Day 4: mean difference = -0.06 [-0.45, 0.33]). There was inter- and intra-individual variability in suvorexant respiratory effects. CONCLUSIONS: Suvorexant 40 mg, twice the 20 mg maximum recommended dose for treating insomnia in the USA and Japan, does not appear to have clinically important respiratory effects during sleep in patients with mild to moderate OSA as assessed by mean AHI and SpO2. Due to inter- and intra-individual variability in respiratory effects, suvorexant should be used with caution in patients with compromised respiratory function, and at the lowest effective dose. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov, NCT01300455.

4 Article A randomized, double-blind, single-dose, placebo-controlled, multicenter, polysomnographic study of gabapentin in transient insomnia induced by sleep phase advance. 2014

Rosenberg, Russell P / Hull, Steven G / Lankford, D Alan / Mayleben, David W / Seiden, David J / Furey, Sandy A / Jayawardena, Shyamalie / Roth, Thomas. ·Neurotrials Research Inc., Atlanta, GA. · Vince and Associates Clinical Research, Overland Park, KS. · Sleep Disorders Center of Georgia, Atlanta, GA. · Community Research, Cincinnati, OH. · Miami Research Associates, Miami, FL. · Pfizer Consumer Healthcare, Pfizer Inc, Madison, NJ. · Sleep Disorders and Research Center, Henry Ford Health System, Detroit, MI. ·J Clin Sleep Med · Pubmed #25317090.

ABSTRACT: STUDY OBJECTIVES: To evaluate the effects of single doses of gabapentin 250 and 500 mg on polysomnographic (PSG) and participant-reported sleep measures in a 5-h phase advance insomnia model. METHODS: Adults reporting occasional disturbed sleep received gabapentin 500 mg (n = 125), 250 mg (n = 125), or placebo (n = 127) 30 min prior to bedtime and were in bed from 17:00 to 01:00, ∼5 h before their habitual bedtime. Sleep was assessed by PSG, post-sleep questionnaire, and the Karolinska Sleep Diary (KSD). Next-day residual effects (Digit Symbol Substitution Test [DSST] and Stanford Sleepiness Scale [SSS]) and tolerability were assessed. RESULTS: Demographics were comparable among groups. Among PSG endpoints, wake after sleep onset (primary endpoint) (135.7 [placebo], 100.7 [250 mg], and 73.2 [500 mg] min) was significantly lower and total sleep time (TST) (311.4, 356.5, and 378.7 min) significantly greater in both gabapentin groups versus placebo. Latency to persistent sleep was not significantly different among groups. Percent slow wave sleep (12.6%, 15.4%, and 17.0%, respectively) was significantly greater and percent stage 1 (15.1%, 11.8%, and 10.8%, respectively) significantly lower relative to placebo. Gabapentin was associated with significantly higher values of KSD Sleep Quality Index and reported TST versus placebo; no other reported outcomes were significant. Neither gabapentin dose produced evidence of next-day residual effects as measured by DSST and SSS. Adverse events were infrequent (< 5%). CONCLUSION: Participants with occasional disturbed sleep treated with gabapentin showed significantly longer sleep duration and greater depth (versus placebo) in response to a phase advance manipulation known to disrupt sleep maintenance.