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Journal: Z-drugs and risk for falls and fractures in older adults-a systematic review and meta-analysis. (Pubmed Central) - Sep 26, 2019 zolpidem, zopiclone, eszopiclone and zaleplon, also known as 'Z-drugs', are commonly used as alternatives to benzodiazepines (BZDs) to treat insomnia...However, studies included were observational and susceptible to confounding. Physicians should consider these potential risks before prescribing these medications in older adults.
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Clinical, Journal: Sedative Hypnotics and the Risk of Falls and Fractures in the Elderly. (Pubmed Central) - Aug 30, 2019 Older age, poor sleep, and the use of the "Z" sedative hypnotic drugs (zopiclone, eszopiclone, zolpidem, and zaleplon) commonly go together...Nonpharmacologic interventions for insomnia should therefore be considered as alternatives to the use of Z-drugs. Finally, patients prescribed Z-drugs and caregivers of these patients should be warned about the risk of falls and fractures and counseled about practical measures that can reduce the risk.
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Trial completion date, Trial primary completion date: CIS2: Safety and Efficacy of Chronic Hypnotic Use 2 (clinicaltrials.gov) - Aug 15, 2019 P4, N=120, Recruiting, Finally, patients prescribed Z-drugs and caregivers of these patients should be warned about the risk of falls and fractures and counseled about practical measures that can reduce the risk. Trial completion date: Dec 2020 --> Dec 2021 | Trial primary completion date: Jul 2020 --> Jul 2021
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Journal: Bitterness-Masking Effects of Different Beverages on Zopiclone and Eszopiclone Tablets. (Pubmed Central) - Jun 14, 2019 H-NMR spectroscopic analysis of mixtures of citric acid with zopiclone suggested that the carboxyl groups of citric acid interact with the amine group on zopiclone. This study therefore showed that the bitterness intensities of zopiclone and eszopiclone can be suppressed by citric-acid-contained beverages and suggests that this bitterness suppression is due to a direct electrostatic interaction between citric acid and the two drugs.
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Enrollment change: Insomnia and Osteoarthritis Study (clinicaltrials.gov) - Mar 14, 2019 P=N/A, N=30, Completed, There was no difference in effect between eszopiclone and zolpidem. N=105 --> 30
- |||||||||| eszopiclone / Generic mfg., trazodone ER / Generic mfg.
Trial completion date, Trial initiation date, Trial primary completion date: NAP: National Adaptive Trial for PTSD Related Insomnia (clinicaltrials.gov) - Mar 11, 2019 P3, N=1224, Not yet recruiting, N=105 --> 30 Trial completion date: Jan 2023 --> Apr 2023 | Initiation date: Aug 2019 --> Nov 2019 | Trial primary completion date: Jan 2023 --> Apr 2023
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Trial completion date: Sleep Effectiveness and Insulin and Glucose Homeostasis (clinicaltrials.gov) - Aug 6, 2018 P1, N=48, Active, not recruiting, Trial completion date: Jan 2023 --> Apr 2023 | Initiation date: Aug 2019 --> Nov 2019 | Trial primary completion date: Jan 2023 --> Apr 2023 Trial completion date: Dec 2018 --> Dec 2020
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Enrollment change: Insomnia and Osteoarthritis Study (clinicaltrials.gov) - Nov 9, 2017 P=N/A, N=105, Completed, Active, not recruiting --> Completed | N=96 --> 60 N=64 --> 105
- |||||||||| eszopiclone / Generic mfg.
Trial completion, Enrollment change, Trial primary completion date: Effects of Eszopiclone on Sleep and Memory in Schizophrenia (clinicaltrials.gov) - Jun 14, 2017 P=N/A, N=59, Completed, N=64 --> 105 Recruiting --> Completed | N=80 --> 59 | Trial primary completion date: Jun 2015 --> Dec 2015
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Trial completion, Enrollment change, Trial primary completion date: Eszopiclone for the Treatment of Posttraumatic Stress Disorder (clinicaltrials.gov) - Apr 16, 2016 P4, N=81, Completed, Recruiting --> Completed Recruiting --> Completed | N=40 --> 81 | Trial primary completion date: Jun 2015 --> Dec 2015
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Enrollment closed, Trial primary completion date: Sleep Effectiveness and Insulin and Glucose Homeostasis (clinicaltrials.gov) - Dec 18, 2015 P=N/A, N=48, Active, not recruiting, Recruiting --> Completed | N=40 --> 81 | Trial primary completion date: Jun 2015 --> Dec 2015 Recruiting --> Active, not recruiting | Trial primary completion date: Aug 2014 --> Aug 2015
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Trial termination: How do Sleeping Pills Affect Pain in the Brain? (clinicaltrials.gov) - Oct 27, 2015 P4, N=40, Terminated, Recruiting --> Active, not recruiting | Trial primary completion date: Aug 2014 --> Aug 2015 Completed --> Terminated; Funding terminated by sponsor, insufficient data collection
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Phase classification: Treatment of Insomnia and Glucose Metabolism (clinicaltrials.gov) - Oct 22, 2015 P4, N=20, Completed, Completed --> Terminated; Funding terminated by sponsor, insufficient data collection Phase classification: P=N/A --> P4
- |||||||||| zolpidem ER / Generic mfg., eszopiclone / Generic mfg.
Enrollment open: CIS2: Safety and Efficacy of Chronic Hypnotic Use 2 (clinicaltrials.gov) - Sep 14, 2015 P4, N=120, Recruiting, Phase classification: P=N/A --> P4 Not yet recruiting --> Recruiting
- |||||||||| eszopiclone / Generic mfg.
Trial completion, Enrollment change, Combination therapy: Combination Therapy to Treat Sleep Apnea (clinicaltrials.gov) - Jul 22, 2015 P=N/A, N=22, Completed, Not yet recruiting --> Completed | Initiation date: May 2010 --> Mar 2011 | Trial primary completion date: May 2010 --> Mar 2012 Recruiting --> Completed | N=60 --> 22
- |||||||||| eszopiclone / Generic mfg.
Enrollment open, Trial primary completion date: AAPI: Auricular Acupuncture for Primary Insomnia (clinicaltrials.gov) - Feb 6, 2015 P=N/A, N=288, Recruiting, Recruiting --> Completed | N=60 --> 22 Not yet recruiting --> Recruiting | Trial primary completion date: Jun 2015 --> Dec 2015
- |||||||||| eszopiclone / Generic mfg.
Enrollment change: Eszopiclone Treatment & Cortisol Responsivity (clinicaltrials.gov) - Nov 4, 2014 P4, N=12, Completed, Not yet recruiting --> Recruiting | Trial primary completion date: Jun 2015 --> Dec 2015 N=15 --> 12
- |||||||||| eszopiclone / Generic mfg.
Trial completion: Insomnia and Osteoarthritis Study (clinicaltrials.gov) - Mar 9, 2014 P=N/A, N=64, Completed, N=30 --> 71 | Initiation date: Jun 2006 --> Jun 2005 Active, not recruiting --> Completed
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