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Sleep Initiation and Maintenance Disorders: HELP
Articles by Milton K. Erman
Based on 6 articles published since 2008

Between 2008 and 2019, Milton Erman wrote the following 6 articles about Sleep Initiation and Maintenance Disorders.
+ Citations + Abstracts
1 Article Insomnia etiology and comorbidity. 2008

Erman, Milton K. ·Department of Psychiatry, School of Medicine of the University of California, San Diego, CA, USA. ·CNS Spectr · Pubmed #19179945.

ABSTRACT: -- No abstract --

2 Article APD125, a selective serotonin 5-HT(2A) receptor inverse agonist, significantly improves sleep maintenance in primary insomnia. 2008

Rosenberg, Russell / Seiden, David J / Hull, Steven G / Erman, Milton / Schwartz, Howard / Anderson, Christen / Prosser, Warren / Shanahan, William / Sanchez, Matilde / Chuang, Emil / Roth, Thomas. ·NeuroTrials Research and Atlanta School of Sleep Medicine, Atlanta 30342, USA. russell.rosenberg@atlantasleep.com ·Sleep · Pubmed #19090322.

ABSTRACT: INTRODUCTION: Insomnia is a condition affecting 10% to 15% of the adult population and is characterized by difficulty falling asleep, difficulty staying asleep, or nonrestorative sleep, accompanied by daytime impairment or distress. This study evaluates APD125, a selective inverse agonist of the 5-HT(2A) receptor, for treatment of chronic insomnia, with particular emphasis on sleep maintenance. In phase 1 studies, APD125 improved sleep maintenance and was well tolerated. METHODOLOGY: Adult subjects (n=173) with DSM-IV defined primary insomnia were randomized into a multicenter, double-blind, placebo-controlled, 3-way crossover study to compare 2 doses of APD125 (10 mg and 40 mg) with placebo. Each treatment period was 7 days with a 7- to 9-day washout period between treatments. Polysomnographic recordings were performed at the initial 2 screening nights and at nights (N) 1/2 and N 6/7 of each treatment period. RESULTS: APD125 was associated with significant improvements in key sleep maintenance parameters measured by PSG. Wake time after sleep onset decreased (SEM) by 52.5 (3.2) min (10 mg) and 53.5 (3.5) min (40 mg) from baseline to N 1/2 vs. 37.8 (3.4) min for placebo, (P < 0.0001 for both doses vs. placebo), and by 51.7 (3.4) min (P = 0.01) and 48.0 (3.6) min (P = 0.2) at N 6/7 vs. 44.0 (3.8) min for placebo. Significant APD125 effects on wake time during sleep were also seen (P < 0.0001 N 1/2, P < 0.001 N 6/7). The number of arousals and number of awakenings decreased significantly with APD125 treatment compared to placebo. Slow wave sleep showed a statistically significant dose-dependent increase. There was no significant decrease in latency to persistent sleep. No serious adverse events were reported, and no meaningful differences in adverse event profiles were observed between either dose of APD125 and placebo. APD125 was not associated with next-day psychomotor impairment as measured by Digit Span, Digit Symbol Copy, and Digit Symbol Coding Tests. CONCLUSIONS: APD125 produced statistically significant improvements in objective parameters of sleep maintenance and sleep consolidation and was well tolerated in adults with primary chronic insomnia.

3 Article Zolpidem extended-release 12.5 mg associated with improvements in work performance in a 6-month randomized, placebo-controlled trial. 2008

Erman, Milton / Guiraud, Alice / Joish, Vijay N / Lerner, Debra. ·Avastra USA, Pacific Sleep Medicine Services, San Diego, CA 92121, USA. ·Sleep · Pubmed #18853934.

ABSTRACT: BACKGROUND: Although most research on pharmacotherapy for chronic insomnia focuses on changes in sleep outcomes, the functional impact of treatment is also of great importance to patients, families, physicians, and employers. OBJECTIVE: To analyze changes in functioning at work (or work performance) among a subset of employed subjects (N = 752) from a 24-week, randomized, double-blind, placebo-controlled trial of zolpidem extended-release 12.5 mg taken nightly, at least 3 nights per week, by healthy adults with chronic insomnia. METHODS: Using 2 scales (Time Management and Work Output) from the Work Limitations Questionnaire (WLQ), subjects' health-related work limitations were evaluated at baseline, week 4, week 12, and week 24 (end of study) or premature discontinuation. To compare zolpidem extended-release 12.5 mg with placebo, within-group and between-group differences were analyzed and effect sizes were computed. The relationship of WLQ scores to scores on the Patient Global Impression, Item 1 (PGI-1), scale, the primary outcome measure for benefit to sleep, was also analyzed. Data were obtained from August 31, 2004 through January 6, 2006. RESULTS: Scores on both WLQ scales were substantially elevated at baseline in this population, reflecting impairment relative to healthy controls. The zolpidem extended-release 12.5 mg group had significantly greater improvement at all time points on the WLQ Time Management (P < 0.0001) and Work Output (P < 0.01) scales. Effect size analysis confirmed the clinical relevance of these improvements. Subjects rating their sleep as improved on the PGI-1 had significantly greater improvement on both WLQ scales at week 12 than did those who reported no benefit or worsening (P < 0.01). CONCLUSIONS: Employed adults with chronic insomnia treated with zolpidem extended-release 12.5 mg experienced significantly improved work performance over 24 weeks.

4 Article A polysomnographic placebo-controlled evaluation of the efficacy and safety of eszopiclone relative to placebo and zolpidem in the treatment of primary insomnia. 2008

Erman, Milton K / Zammit, Gary / Rubens, Robert / Schaefer, Kendyl / Wessel, Thomas / Amato, David / Caron, Judy / Walsh, James K. ·Pacific Sleep Medicine Services, Inc., San Diego, CA, USA. ·J Clin Sleep Med · Pubmed #18595435.

ABSTRACT: STUDY OBJECTIVES: To evaluate the polysomnographic efficacy and the safety of a range of doses of eszopiclone relative to placebo in patients with primary insomnia. Zolpidem 10 mg was included as an active control. METHODS: This multicenter, randomized, crossover study enrolled patients aged 21-64 years meeting the DSM-IV criteria for primary insomnia (n = 65). Patients received 2 nights treatment each with placebo, eszopiclone 1 mg, 2 mg, 2.5 mg, or 3 mg, and zolpidem 10 mg after randomization to one of 6 treatment sequences. Visits were separated by a 3-7 day washout. Objective efficacy was assessed by polysomnography (PSG). The primary endpoint was latency to persistent sleep (LPS); key secondary endpoints were sleep efficiency (SE) and wake time after sleep onset (WASO); other endpoints included wake time during sleep (WTDS) and number of awakenings (NAW), as well as patient-reported variables. RESULTS: LPS and SE were significantly different than placebo for all active treatments (p < 0.05 for all). Significant differences from placebo were noted in the 3 objective sleep maintenance measures (WASO, WTDS, and NAW) for eszopiclone 3 mg (p < 0.05), which was not the case for zolpidem 10 mg or the other eszopiclone doses. The incidence of central nervous system adverse events was 23.4% for zolpidem 10 mg, 6.2% to 12.5% for the eszopiclone doses, and 7.9% for placebo. CONCLUSIONS: Relative to placebo, all active treatments were effective in reducing LPS and increasing SE. Eszopiclone 3 mg was significantly different from placebo on the 3 PSG measures of sleep maintenance (WASO, WTDS, and NAW). Significant differences between zolpidem 10 mg and eszopiclone (2 mg or 3 mg) were not observed for PSG-measured outcomes, although the study was not powered to detect differences between the active drug conditions.

5 Article Long-term efficacy and safety of zolpidem extended-release 12.5 mg, administered 3 to 7 nights per week for 24 weeks, in patients with chronic primary insomnia: a 6-month, randomized, double-blind, placebo-controlled, parallel-group, multicenter study. 2008

Krystal, Andrew D / Erman, Milton / Zammit, Gary K / Soubrane, C / Roth, Thomas / Anonymous7470590. ·Duke University Medical Center, Durham, NC 27710, USA. kryst001@mc.duke.edu ·Sleep · Pubmed #18220081.

ABSTRACT: STUDY OBJECTIVES: To evaluate long-term efficacy and safety of zolpidem extended-release 3 to 7 nights/week for chronic primary insomnia. DESIGN: Multicenter, 25-week, phase IIIb, randomized, double-blind, placebo-controlled, parallel-group. SETTING: Outpatient; visits every 4 weeks. PATIENTS: Aged 18 to 64 years; DSM-IV criteria for chronic primary insomnia; > or =3 months of difficulty initiating or maintaining sleep or experiencing nonrestorative sleep. INTERVENTIONS: Single-dose zolpidem extended-release 12.5 mg (n = 669) or placebo (n = 349), self-administered from a minimum of 3 nights/week to a maximum of 7 nights/week. MEASUREMENTS AND RESULTS: Patient's Global Impression (PGI) and Clinical Global Impression-Improvement (CGI-I) were assessed every 4 weeks up to week 24. Patient Morning Questionnaire (PMQ), recorded daily, assessed subjective sleep measures-sleep onset latency (SOL), total sleep time (TST), number of awakenings (NAW), wake time after sleep onset (WASO), and quality of sleep (QOS)-and next-day functioning. At week 12, PGI, Item 1 (aid to sleep), the primary endpoint, was scored as favorable (i.e., "helped me sleep") by 89.8% of zolpidem patients vs. 51.4% of placebo patients (P < 0.0001, based on rank score) and at week 24 by 92.3% of zolpidem extended-release patients vs. 59.7% of placebo patients. Zolpidem extended-release also was statistically significantly superior to placebo at every time point for PGI (Items 1-4) and CGI-I (P < 0.0001, rank score), TST, WASO, QOS (P < 0.0001), and SOL (P < or = 0.0014); NAW (Months 2-6; P < 0.0001). Sustained improvement (P < 0.0001, all time points) was observed in morning sleepiness and ability to concentrate (P = 0.0014, month 6) with zolpidem extended-release compared with placebo. Most frequent adverse events for zolpidem extended-release were headache, anxiety and somnolence. No rebound effect was observed during the first 3 nights of discontinuation. CONCLUSIONS: These findings establish the efficacy of 3 to 7 nights per week dosing of zolpidem extended-release 12.5 mg for up to 6 months. Treatment provided sustained and significant improvements in sleep onset and maintenance and also improved next-day concentration and morning sleepiness.

6 Unspecified New perspectives in the diagnosis and management of insomnia. Introduction. 2008

Erman, Milton K. ·Department of Psychiatry, School of Medicine of the University of California, San Diego, CA, USA. ·CNS Spectr · Pubmed #19179944.

ABSTRACT: -- No abstract --