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https://www.readbyqxmd.com/read/25968811/methodological-approaches-to-evaluate-the-impact-of-fda-drug-safety-communications
#1
Aaron S Kesselheim, Eric G Campbell, Sebastian Schneeweiss, Paula Rausch, Brian M Lappin, Esther H Zhou, John D Seeger, John S Brownstein, Steven Woloshin, Lisa M Schwartz, Timothy Toomey, Gerald J Dal Pan, Jerry Avorn
BACKGROUND: When the US FDA approves a new prescription drug there is still a great deal remaining to be learned about the safe and proper use of that product. When new information addressing these topics emerges post-approval, the FDA may issue a Drug Safety Communication (DSC) to alert patients and physicians. The effectiveness of the communication-how drug safety messaging conveyed in FDA DSCs changes patient or prescriber behavior-may depend on multiple factors, including the way physicians and patients learn about the information, their understanding of the issues conveyed, and their perception of the importance of the information...
June 2015: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/25323219/efficacy-of-treatment-of-insomnia-in-migraineurs-with-eszopiclone-lunesta%C3%A2-and-its-effect-on-total-sleep-time-headache-frequency-and-daytime-functioning-a-randomized-double-blind-placebo-controlled-parallel-group-pilot-study
#2
RANDOMIZED CONTROLLED TRIAL
Egilius L H Spierings, Peter J McAllister, Tanya R Bilchik
AIMS: A review on headache and insomnia revealed that insomnia is a risk factor for increased headache frequency and headache intensity in migraineurs. The authors designed a randomized, double blind, placebo-controlled, parallel-group, pilot study in which migraineurs who also had insomnia were enrolled, to test this observation. METHODOLOGY: In the study, the authors treated 79 subjects with IHS-II migraine with and/or without aura and with DSM-IV primary insomnia for 6 weeks with 3 mg eszopiclone (Lunesta(®)) or placebo at bedtime...
April 2015: Cranio: the Journal of Craniomandibular Practice
https://www.readbyqxmd.com/read/24933089/in-brief-lowering-the-dose-of-lunesta
#3
(no author information available yet)
No abstract text is available yet for this article.
June 9, 2014: Medical Letter on Drugs and Therapeutics
https://www.readbyqxmd.com/read/24453709/effect-of-eszopiclone-on-sleep-disturbances-and-daytime-fatigue-in-multiple-sclerosis-patients
#4
Hrayr Attarian, Garrick Applebee, Angela Applebee, Bingxia Wang, Melissa Clark, Becky McCormick, Emma Salzman, Catherine Schuman
The prevalence of moderate-to-severe sleep problems is significantly higher among people with multiple sclerosis (MS) than in the general population. In 2002, we found a significant relationship between fatigue and disrupted sleep in patients with relapsing-remitting MS (RRMS). The objectives of this study were to determine whether eszopiclone (Lunesta; Sunovion Pharmaceuticals Inc, Marlborough, MA) was superior to placebo in improving sleep among patients with MS-related fatigue and sleep complaints (primary end point); and to assess the impact of improved sleep on daytime fatigue and functioning (secondary end point)...
2011: International Journal of MS Care
https://www.readbyqxmd.com/read/23997371/the-effects-of-eszopiclone-on-sleep-spindles-and-memory-consolidation-in-schizophrenia-a-randomized-placebo-controlled-trial
#5
RANDOMIZED CONTROLLED TRIAL
Erin J Wamsley, Ann K Shinn, Matthew A Tucker, Kim E Ono, Sophia K McKinley, Alice V Ely, Donald C Goff, Robert Stickgold, Dara S Manoach
STUDY OBJECTIVES: In schizophrenia there is a dramatic reduction of sleep spindles that predicts deficient sleep-dependent memory consolidation. Eszopiclone (Lunesta), a non-benzodiazepine hypnotic, acts on γ-aminobutyric acid (GABA) neurons in the thalamic reticular nucleus where spindles are generated. We investigated whether eszopiclone could increase spindles and thereby improve memory consolidation in schizophrenia. DESIGN: In a double-blind design, patients were randomly assigned to receive either placebo or 3 mg of eszopiclone...
September 2013: Sleep
https://www.readbyqxmd.com/read/23552372/orexin-receptor-antagonists-differ-from-standard-sleep-drugs-by-promoting-sleep-at-doses-that-do-not-disrupt-cognition
#6
Jason M Uslaner, Spencer J Tye, Donnie M Eddins, Xiaohai Wang, Steven V Fox, Alan T Savitz, Jacquelyn Binns, Christopher E Cannon, Susan L Garson, Lihang Yao, Robert Hodgson, Joanne Stevens, Mark R Bowlby, Pamela L Tannenbaum, Joseph Brunner, Terrence P Mcdonald, Anthony L Gotter, Scott D Kuduk, Paul J Coleman, Christopher J Winrow, John J Renger
Current treatments for insomnia, such as zolpidem (Ambien) and eszopiclone (Lunesta), are γ-aminobutyric acid type A (GABAA)-positive allosteric modulators that carry a number of side effects including the potential to disrupt cognition. In an effort to develop better tolerated medicines, we have identified dual orexin 1 and 2 receptor antagonists (DORAs), which promote sleep in preclinical animal models and humans. We compare the effects of orally administered eszopiclone, zolpidem, and diazepam to the dual orexin receptor antagonist DORA-22 on sleep and the novel object recognition test in rat, and on sleep and two cognition tests (delayed match to sample and serial choice reaction time) in the rhesus monkey...
April 3, 2013: Science Translational Medicine
https://www.readbyqxmd.com/read/21540024/eszopiclone-stimulates-the-hypothalamo-pituitary-adrenal-axis-in-the-rat
#7
Robert N Pechnick, Liliana M Lacayo, Charlene M Manalo, Yasmin Bholat, Inna Spivak
Eszopiclone (Lunesta®) is used for the treatment of insomnia. It is the S (+)-enantiomer of racemic zopiclone, a cyclopyrrolone with no structural similarity to the hypnotic drugs zolpidem and zaleplon or to the benzodiazepines and barbiturates. Although eszopiclone interacts with the gamma-aminobutyric acid A-type (GABA(A)) receptor complex, it has a different binding profile than other sedative/hypnotic agents and modulates the receptor complex in a unique manner. Thus, eszopiclone might produce different pharmacological effects compared to other sedative/hypnotic agents...
July 1, 2011: European Journal of Pharmacology
https://www.readbyqxmd.com/read/21397868/mindfulness-based-stress-reduction-versus-pharmacotherapy-for-chronic-primary-insomnia-a-randomized-controlled-clinical-trial
#8
RANDOMIZED CONTROLLED TRIAL
Cynthia R Gross, Mary Jo Kreitzer, Maryanne Reilly-Spong, Melanie Wall, Nicole Y Winbush, Robert Patterson, Mark Mahowald, Michel Cramer-Bornemann
OBJECTIVE: The aim of this study was to investigate the potential of mindfulness-based stress reduction (MBSR) as a treatment for chronic primary insomnia. DESIGN: A randomized controlled trial was conducted. SETTING: The study was conducted at a university health center. PATIENTS: Thirty adults with primary chronic insomnia based on criteria of the Diagnostic and Statistical Manual of Mental Disorders, Text Revision, 4th Edition were randomized 2:1 to MBSR or pharmacotherapy (PCT)...
March 2011: Explore: the Journal of Science and Healing
https://www.readbyqxmd.com/read/20528426/cost-effectiveness-of-eszopiclone-for-the-treatment-of-chronic-insomnia
#9
Cynthia J Halas
Eszopiclone (Lunesta) is the first hypnotic to receive US FDA approval for the long-term treatment of chronic insomnia. This novel nonbenzodiazepine hypnotic provides another option for patients with sleep disorders by inducing rapid-sleep onset and sleep maintenance. The drug is effective and well tolerated in adult patients with insomnia. Eszopiclone is more expensive than some other nonbenzodiazepine hypnotics (zaleplon, immediate release zolpidem) and benzodiazepine hypnotics, and much less expensive than controlled-release zolpidem...
February 2007: Expert Review of Pharmacoeconomics & Outcomes Research
https://www.readbyqxmd.com/read/19772869/a-double-blind-study-of-the-influences-of-eszopiclone-on-dysgeusia-and-taste-function
#10
RANDOMIZED CONTROLLED TRIAL
Richard L Doty, Jonathan Treem, Isabelle Tourbier, Natasha Mirza
Taste disturbance is a common, but poorly understood, side effect of a large number of medications. This double-blind study examined the frequency, intensity, and quality of taste disturbances related to the widely used hypnotic sleep aid eszopiclone (ESZ; Lunesta, as well as their associations with age, sex, body mass index (BMI), time of day, phenyl thiocarbamide (PTC) taste sensitivity, and ESZ saliva and blood levels. Sixty six percent of 24 female subjects and 53% of 15 male subjects reported dysgeusic sensations, mostly bitter/metallic, during the drug administration (respective placebo figures 17% and 7%)...
December 2009: Pharmacology, Biochemistry, and Behavior
https://www.readbyqxmd.com/read/19033556/the-modulation-of-synaptic-gaba-a-receptors-in-the-thalamus-by-eszopiclone-and-zolpidem
#11
Fan Jia, Peter A Goldstein, Neil L Harrison
Eszopiclone (Lunesta; Sepracor, Marlborough, MA) and zolpidem [N,N,6-trimethyl-2-(4-methylphenyl)-imidazo(1,2-a)pyridine-3-acetamide] are among the most commonly prescribed hypnotics in use in the United States. The thalamus plays a pivotal role in sleep regulation and rhythmicity. Two distinct subtypes of synaptic GABA(A) receptors (GABA(A)-Rs), alpha(1)beta(2)gamma(2) and alpha(3)beta(3)gamma(2), are expressed in thalamocortical relay neurons and in interneurons of the RTN (reticular thalamic nucleus), respectively...
March 2009: Journal of Pharmacology and Experimental Therapeutics
https://www.readbyqxmd.com/read/18840036/spotlight-on-eszopiclone-in-insomnia
#12
Philip I Hair, Paul L McCormack, Monique P Curran
Eszopiclone (Lunesta), the S-enantiomer of racemic zopiclone, is a nonbenzodiazepine hypnotic agent that is approved in the US as an oral, once-nightly therapy for insomnia in adults; eszopiclone is also currently under review by the European Medicines Agency.Eszopiclone is rapidly absorbed after oral administration without any next-day clinical residual effects being detected. Large, well designed trials of up to 6 months' duration have shown that eszopiclone significantly improves both sleep onset and sleep maintenance compared with placebo in adult and elderly patients with primary insomnia...
2008: CNS Drugs
https://www.readbyqxmd.com/read/18578559/eszopiclone-a-review-of-its-use-in-the-treatment-of-insomnia
#13
REVIEW
Philip I Hair, Paul L McCormack, Monique P Curran
Eszopiclone (Lunesta), the S-enantiomer of racemic zopiclone, is a nonbenzodiazepine hypnotic agent that is approved in the US as an oral, once-nightly therapy for insomnia in adults; eszopiclone is also currently under review by the European Medicines Agency. Eszopiclone is rapidly absorbed after oral administration without any next-day clinical residual effects being detected. Large, well designed trials of up to 6 months' duration have shown that eszopiclone significantly improves both sleep onset and sleep maintenance compared with placebo in adult and elderly patients with primary insomnia...
2008: Drugs
https://www.readbyqxmd.com/read/18488591/lunesta-for-the-treatment-of-insomnia
#14
Michelle J Lajiness
No abstract text is available yet for this article.
April 2008: Urologic Nursing
https://www.readbyqxmd.com/read/18069595/what-every-dentist-should-know-about-the-z-sedatives
#15
Wm Stuart McKenzie, Morton Rosenberg
According to the National Institutes of Health, approximately 30 percent of all Americans complain of sleep disruption, while 10 percent display symptoms congruent with chronic insomnia. One of the most common treatments for insomnia is prescription sleep medications that help people fall asleep and remain asleep. Historically barbiturates were initially popular for treating insomnia, but their long "hangover" effect made them easily replaced with the introduction of the benzodiazepines. Triazolam (Halcion), diazepam (Valium), and oxazepam (Serax) rapidly became the treatment of choice for insomnia...
2007: Journal of the Massachusetts Dental Society
https://www.readbyqxmd.com/read/17381185/cost-effectiveness-of-long-term-treatment-with-eszopiclone-for-primary-insomnia-in-adults-a-decision-analytical-model
#16
Marc F Botteman, Ron J Ozminkowski, Shaohung Wang, Chris L Pashos, Kendyl Schaefer, Daniel J Foley
OBJECTIVE: Although the clinical benefits of pharmacological treatments for insomnia have been studied, no systematic assessment of their economic value has been reported. This analysis assessed, from a broad payer and societal perspective, the cost effectiveness of long-term treatment with eszopiclone (LUNESTA, Sepracor Inc., [Marlborough, MA, USA]) for chronic primary insomnia in adults in the US. METHODS: A decision analytical model was developed based on the reanalysis of a 6-month placebo-controlled trial, which demonstrated that eszopiclone 3mg significantly improved sleep and daytime function measures versus placebo in adults with primary insomnia...
2007: CNS Drugs
https://www.readbyqxmd.com/read/16984850/lunesta-overdose-st-elevation-coronary-vasospasm-troponemia-and-ventricular-fibrillation-arrest
#17
Adam H Miller, Amanda R Bruggman, Margarita M Miller
No abstract text is available yet for this article.
October 2006: American Journal of Emergency Medicine
https://www.readbyqxmd.com/read/16424933/eszopiclone-lunesta-a-new-nonbenzodiazepine-hypnotic-agent
#18
Benjamin D Brielmaier
Randomized, placebo-controlled trials have shown that eszopiclone, a newly available nonbenzodiazepine hypnotic, effectively treats the symptoms of insomnia. Its pharmacokinetic and pharmacodynamic parameters are similar to those of the other currently available nonbenzodiazepine hypnotics (i.e., zolpidem and zaleplon). The unique quality of eszopiclone lies in its product labeling. It is not restricted to short-term use, unlike both zolpidem and zaleplon. Dosing of eszopiclone should begin at 2 mg for nonelderly patients and may be initiated at or increased to 3 mg if clinically indicated...
January 2006: Proceedings of the Baylor University Medical Center
https://www.readbyqxmd.com/read/16151317/eszopiclone-lunesta-for-treatment-of-insomnia
#19
Gary Laustsen
No abstract text is available yet for this article.
September 2005: Nurse Practitioner
https://www.readbyqxmd.com/read/16055594/eszopiclone-lunesta-a-new-hypnotic
#20
(no author information available yet)
No abstract text is available yet for this article.
August 2005: Obstetrics and Gynecology
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