The DOI matches its Crossref record; 23 of the 23 references it cites were found in a registry or an index.
An evaluation of the efficacy and safety of eszopiclone over 12 months in patients with chronic primary insomnia
Abstract
Background and purpose A double-blind placebo-controlled study of eszopiclone found significant, sustained improvement in sleep and daytime function. The 6-month open-label extension phase is described herein.Patients and methods Adults (21-64) with primary insomnia who reported sleep duration <6.5 h/night or sleep latency >30 min/night were included. Patient-reported endpoints included sleep and daytime function. Safety and compliance were assessed at monthly clinic visits. The final double-blind month was used as the baseline for efficacy analyses of the open-label period.Results Patients who were initially randomized to double-blind placebo and then switched to open-label eszopiclone (n=111) significantly reported the following: (1) decreased sleep latency, wake time after sleep onset, and number of awakenings; (2) increased total sleep time and sleep quality; and (3) improved ratings of daytime ability to function, alertness and sense of physical well-being compared to baseline (P<or=0.0001 all monthly endpoints). There was no evidence of tolerance on any measure in either group. These subjects (n=360) sustained the double-blind treatment gains for all sleep and daytime parameters, with further significant improvement in a number of measures. Eszopiclone was well tolerated in both groups; unpleasant taste was the only undesirable effect reported by >5% of patients.Conclusions The significant improvements in sleep and daytime function were evident in those switched from double-blind placebo to 6 months of open-label eszopiclone therapy and were sustained during the 6 months of open-label treatment for those receiving prior double-blind eszopiclone. During 12 months of nightly treatment, eszopiclone 3mg was well tolerated; tolerance was not observed.
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“Nevertheless, current evidence 33 34 35 36 37 does not support the development of tolerance or rebound insomnia following eszopiclone discontinuation in primary insomnia patients.”
From Z-drug abuse and dependence: Clinical guideline of the Brazilian Academy of Neurology for diagnosis and management (2025) · cites this paper as [35]
In the citing paper
“In clinical practice, hypnotic medications are often used over durations of one to twelve months without dosage escalation, 52-55”
From Clinical Guideline for the Evaluation and Management of Chronic Insomnia in Adults (2008) · cites this paper as [53]
Citations
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Self-citationBehavioral and Pharmacological Therapies for Late-Life Insomnia: A Randomized Controlled Trial
Morin, C. M., Colecchi, C., Stone, J., Sood, R., & Brink, D. (1999) · JAMA · doi:10.1001/jama.281.11.991 · Cited by 1,095
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Self-citationKrystal, A. D., Walsh, J. K., Laska, E., Caron, J., Amato, D. A., Wessel, T. C., & Roth, T. (2003) · Sleep · doi:10.1093/sleep/26.7.793 · Cited by 630
Self-citationClinical correlates of insomnia in patients with chronic illness
Katz, D. A., & McHorney, C. A. (1998) · Archives of Internal Medicine · doi:10.1001/archinte.158.10.1099 · Cited by 480 · cited 1×
“Although limited data regarding the natural course of chronic insomnia exist, available data suggest that untreated insomnia persists at least 2 years in more than half of the respondents [6–9].”
BackgroundBenzodiazepines and Zolpidem for Chronic Insomnia: A Meta-analysis of Treatment Efficacy
Nowell, P. D. (1997) · JAMA · doi:10.1001/jama.1997.03550240060035 · Cited by 451
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European guideline for the diagnosis and treatment of insomnia
Riemann, D., Baglioni, C., Bassetti, C., Bjorvatn, B., Dolenc Groselj, L., Ellis, J. G., Espie, C. A., Garcia‐Borreguero, D., Gjerstad, M., Gonçalves, M., et al. (2017) · Journal of Sleep Research · doi:10.1111/jsr.12594 · Cited by 2,049
Clinical Guideline for the Evaluation and Management of Chronic Insomnia in Adults
Schutte-Rodin, S., Broch, L., Buysse, D., Dorsey, C., & Sateia, M. (2008) · Journal of Clinical Sleep Medicine · doi:10.5664/jcsm.27286 · Cited by 1,943
Fava, M., McCall, W. V., Krystal, A., Wessel, T., Rubens, R., Caron, J., Amato, D., & Roth, T. (2006) · Biological Psychiatry · doi:10.1016/j.biopsych.2006.01.016 · Cited by 480
Self-citationReview of Safety and Efficacy of Sleep Medicines in Older Adults
Schroeck, J. L., Ford, J., Conway, E. L., Kurtzhalts, K. E., Gee, M. E., Vollmer, K. A., & Mergenhagen, K. A. (2016) · Clinical Therapeutics · doi:10.1016/j.clinthera.2016.09.010 · Cited by 388
S3-Leitlinie Nicht erholsamer Schlaf/Schlafstörungen
Riemann, D. W., Baum, E., Cohrs, S., Crönlein, T., Hajak, G., Hertenstein, E., Klose, P., Langhorst, J., Mayer, G., Nissen, C., et al. (2017) · Somnologie - Schlafforschung und Schlafmedizin · doi:10.1007/s11818-016-0097-x · Cited by 354
Metadata
- Authors
- ROTH, T., WALSH, J., KRYSTAL, A., WESSEL, T., & ROEHRS, T.
- Affiliations
- Henry Ford Hospital (US)
- Duke University (US)
- Sunovion (United States) (US)
- Corresponding author
- ROTH, T
- Venue
- Sleep Medicine
- Publisher
- Elsevier BV
- Published
- 2005-11
- Volume
- 6
- Issue
- 6
- Pages
- 487-495
- ISSN
- 1389-9457 (ISSN-L)
- OpenAlex
- W2066580767
- Cited by
- 230
- References
- 23
- Citations by year
- 2026: 5 · 2025: 4 · 2024: 7 · 2023: 10 · 2022: 5 · 2021: 6 · 2020: 4 · 2019: 4 · 2018: 9 · 2017: 9 · 2016: 12 · 2015: 10 · 2014: 19 · 2013: 7 · 2012: 13
- FWCI
- 27.21
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Sleep Medicine (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and related disorders
- Health Sciences › Medicine › Physiology (medical) › Obstructive Sleep Apnea Research
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and Work-Related Fatigue
- Keywords
- eszopiclone, chronic primary insomnia, long-term efficacy, sustained treatment effects, daytime functioning, sleep latency, sleep quality, wake after sleep onset, awakening, drug safety, tolerability, open-label extension
- MeSH terms
- Adult, Aged, Drug Administration Schedule, Female, Follow-Up Studies, Humans, Hypnotics and Sedatives, Sleep Initiation and Maintenance Disorders, Male, Middle Aged, Piperazines, Treatment Outcome, Cross-Over Studies, Azabicyclo Compounds
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