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https://www.readbyqxmd.com/read/28339323/media-coverage-of-fda-drug-safety-communications-about-zolpidem-a-quantitative-and-qualitative-analysis
#1
Steve Woloshin, Lisa M Schwartz, Sara Dejene, Paula Rausch, Gerald J Dal Pan, Esther H Zhou, Aaron S Kesselheim
FDA issues Drug Safety Communications (DSCs) to alert health care professionals and the public about emerging safety information affecting prescription and over-the-counter drugs. News media may amplify DSCs, but it is unclear how DSC messaging is transmitted through the media. We conducted a content analysis of the lay media coverage reaching the broadest audience to characterize the amount and content of media coverage of two zolpidem DSCs from 2013. After the first DSC, zolpidem news stories increased from 19 stories/week in the preceding 3 months to 153 following its release...
March 24, 2017: Journal of Health Communication
https://www.readbyqxmd.com/read/28326532/common-drug-side-effects-and-drug-drug-interactions-in-elderly-adults-in-primary-care
#2
Susan E Merel, Douglas S Paauw
Prescribing medications, recognizing and managing medication side effects and drug interactions, and avoiding polypharmacy are all essential skills in the care of older adults in primary care. Important side effects of medications commonly prescribed in older adults (statins, proton pump inhibitors, trimethoprim-sulfamethoxazole and fluoroquinolone antibiotics, zolpidem, nonsteroidal antiinflammatory drugs, selective serotonin reuptake inhibitors, dipeptidyl peptidase 4 inhibitors) were reviewed. Important drug interactions with four agents or classes (statins, warfarin, factor Xa inhibitors, and calcium channel blockers) are discussed...
March 21, 2017: Journal of the American Geriatrics Society
https://www.readbyqxmd.com/read/28286289/mechanistic-investigation-of-the-negative-food-effect-of-modified-release-zolpidem
#3
Cord J Andreas, Xavier Pepin, Constantinos Markopoulos, Maria Vertzoni, Christos Reppas, Jennifer Dressman
AIMS: When administered orally as either an immediate or modified release dosage form, zolpidem demonstrates a negative food effect, i.e. decrease in Cmax and AUC. The aim of the study was to arrive at a better understanding of the absorption of this BCS class I compound, in vivo and to simulate the observed plasma profiles using in vitro and in silico methods. METHODS: Pharmacokinetic profiles of zolpidem are presented from a bioavailability (8mg intravenous; 10mg immediate release Stilnox®; 10mg and 12...
March 9, 2017: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28279667/preclinical-assessment-of-the-abuse-potential-of-the-orexin-receptor-antagonist-suvorexant
#4
Stephanie Born, David V Gauvin, Suman Mukherjee, Richard Briscoe
Suvorexant (Belsomra(®)) is a dual orexin receptor antagonist approved for the treatment of insomnia. Because of its pharmacology within the central nervous system, intended therapeutic indication, and first-in-class status, an assessment of suvorexant abuse liability potential was required prior to marketing approval. The nonclinical abuse liability potential studies for suvorexant included: 1) rat drug-dependence model to assess physical dependence following abrupt cessation; 2) rat drug-discrimination model to examine the potential similarity of the interoceptive or subjective effects of suvorexant to those elicited by zolpidem and morphine; 3) self-administration model to assess the relative reinforcing efficacy of suvorexant in rhesus monkeys conditioned to self-administer methohexital...
March 6, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28262178/zolpidem-s-use-for-insomnia
#5
REVIEW
Jaime M Monti, David Warren Spence, Kenneth Buttoo, Seithikurippu R Pandi-Perumal
Zolpidem is a short-acting non-benzodiazepine hypnotic drug that belongs to the imidazopyridine class. In addition to immediate-release (IR) and extended-release (ER) formulations, the new delivery forms including two sublingual tablets [standard dose (SD) and low dose (LD)], and an oral spray form have been recently developed which bypass the gastrointestinal tract. So far, Zolpidem has been studied in several clinical populations: cases poor sleepers, transient insomnia, elderly and non-elderly patients with chronic primary insomnia, and in comorbid insomnia...
February 2017: Asian Journal of Psychiatry
https://www.readbyqxmd.com/read/28247279/patient-and-physician-perceptions-of-drug-safety-information-for-sleep-aids-a-qualitative-study
#6
Aaron S Kesselheim, Sarah A McGraw, Sara Z Dejene, Paula Rausch, Gerald J Dal Pan, Brian M Lappin, Esther H Zhou, Jerry Avorn, Eric G Campbell
INTRODUCTION: The US Food and Drug Administration uses drug safety communications (DSCs) to release emerging information regarding post-market safety issues, but it is unclear the extent of awareness by patients and providers of these communications and their specific recommendations. OBJECTIVE: We conducted semi-structured interviews with patients and physicians to evaluate their awareness and understanding of emerging drug safety information related to two sleep aids: zolpidem or eszopiclone...
February 28, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28236619/comparison-between-acupuncture-and-biofeedback-as-adjunctive-treatments-for-primary-insomnia-disorder
#7
Hsien-Te Huang, Shang-Lun Lin, Chi-Hung Lin, Dong-Sheng Tzeng
Context • Insomnia affects from 5% to 35% of the general population worldwide. Primary insomnia disorder is the most frequently diagnosed, sleep-related disorder. Pharmacological treatments remain the most widely used treatments for insomnia. Nonpharmacological treatments for primary insomnia disorder have been found to be effective. Objective • This study intended to determine the appropriateness of acupuncture and biofeedback as adjuncts to medication for primary insomnia disorder. Design • The research team designed a randomized, controlled study...
February 27, 2017: Alternative Therapies in Health and Medicine
https://www.readbyqxmd.com/read/28207998/benzodiazepine-and-z-drug-dependence-data-from-a-tertiary-care-center
#8
Lekhansh Shukla, Spandana Bokka, Tulika Shukla, Arun Kandasamy, Prabhat Chand, Vivek Benegal, Pratima Murthy
Objective: To examine the clinical characteristics and course of benzodiazepine and �Z-drug� dependence in patients presenting to a tertiary deaddiction center in southern India. Methods: Case files of 950 inpatients admitted between January 2007 and January 2014 who reported benzodiazepine or Z-drug use were reviewed. Patients (n = 170) with an ICD-10 diagnosis of mental and behavioral disorders due to the use of sedatives or hypnotics-dependence syndrome currently using substance (F13...
February 16, 2017: Primary Care Companion to CNS Disorders
https://www.readbyqxmd.com/read/28181568/predictive-modeling-of-physician-patient-dynamics-that-influence-sleep-medication-prescriptions-and-clinical-decision-making
#9
Andrew L Beam, Uri Kartoun, Jennifer K Pai, Arnaub K Chatterjee, Timothy P Fitzgerald, Stanley Y Shaw, Isaac S Kohane
Insomnia remains under-diagnosed and poorly treated despite its high economic and social costs. Though previous work has examined how patient characteristics affect sleep medication prescriptions, the role of physician characteristics that influence this clinical decision remains unclear. We sought to understand patient and physician factors that influence sleep medication prescribing patterns by analyzing Electronic Medical Records (EMRs) including the narrative clinical notes as well as codified data. Zolpidem and trazodone were the most widely prescribed initial sleep medication in a cohort of 1,105 patients...
February 9, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28162647/-403-co-administration-of-mirogabalin-and-zolpidem-in-healthy-subjects-results-from-a-randomized-double-blind-drug-drug-interaction-study
#10
M Jansen, D Merante, A Currie, M Velinova, K Brown, H Zahir
No abstract text is available yet for this article.
April 2016: Journal of Pain: Official Journal of the American Pain Society
https://www.readbyqxmd.com/read/28106623/symptom-presentation-and-prescription-of-sleep-medications-for-veterans-with-posttraumatic-stress-disorder
#11
Mark A Greenbaum, Thomas C Neylan, Craig S Rosen
This study tested whether sleep medications prescribed to veterans diagnosed with posttraumatic stress disorder (PTSD) are being targeted to patients who report more severe insomnia or nightmares. Secondary analysis of survey and pharmacy data was conducted in samples of veterans from two periods: from 2006 to 2008 and from 2009 to 2013. Logistic regression tested associations between self-reported insomnia and nightmare severity, and being prescribed trazodone, prazosin, zolpidem, and benzodiazepines, controlling for PTSD severity and other covariates...
February 2017: Journal of Nervous and Mental Disease
https://www.readbyqxmd.com/read/28101753/effect-and-safety-of-paroxetine-combined-with-zolpidem-in-treatment-of-primary-insomnia
#12
Z H Yu, X H Xu, S D Wang, M F Song, Y Liu, Y Yin, H J Mao, G Z Tang
PURPOSE: Primary insomnia is a persistent and recurrent disorder as well as a risk factor for depression. The aim of this study was to determine whether the zolpidem combined with paroxetine would be effective in the treatment of patients with primary insomnia. METHODS: Ninety patients meeting DSM-IV criteria for primary insomnia were randomly assigned to 8 weeks of treatment with zolpidem combined with paroxetine (the combined treatment group, n = 45) or zolpidem combined with placebo (the control group, n = 45)...
January 18, 2017: Sleep & Breathing, Schlaf & Atmung
https://www.readbyqxmd.com/read/28099356/increased-risk-of-parkinson-disease-with-diabetes-mellitus-in-a-population-based-study
#13
Yu-Wan Yang, Teng-Fu Hsieh, Chia-Ing Li, Chiu-Shong Liu, Wen-Yuan Lin, Jen-Huai Chiang, Tsai-Chung Li, Cheng-Chieh Lin
This nationwide population-based study investigated the risk of Parkinson disease (PD) in relation to diabetes mellitus (DM) through the National Health Insurance Research Database in Taiwan.A retrospective study was conducted, consisting of 36,294 patients who were newly diagnosed with DM between January 1, 2000 and December 31, 2006 and 108,882 individuals without DM as healthy controls from insurance claims data from Taiwan's National Health Research Institutes Dataset. The subjects were followed up until December 31, 2011 or until the first manifestation of PD...
January 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/28094153/development-and-validation-of-a-fast-ionic-liquid-based-dispersive-liquid-liquid-microextraction-procedure-combined-with-lc-ms-ms-analysis-for-the-quantification-of-benzodiazepines-and-benzodiazepine-like-hypnotics-in-whole-blood
#14
Marieke De Boeck, Sophie Missotten, Wim Dehaen, Jan Tytgat, Eva Cuypers
To date, thorough clean-up of complex biological samples remains an essential part of the analytical process. The solid phase extraction (SPE) technique is the well-known standard, however, its main weaknesses are the labor-intensive and time-consuming protocols. In this respect, dispersive liquid-liquid microextractions (DLLME) seem to offer less complex and more efficient extraction procedures. Furthermore, ionic liquids (ILs) - liquid salts - are emerging as new promising extraction solvents, thanks to their non-flammable nature, negligible vapor pressure and easily adaptable physiochemical properties...
December 26, 2016: Forensic Science International
https://www.readbyqxmd.com/read/28093373/improved-arousal-and-motor-function-using-zolpidem-in-a-patient-with-space-occupying-intracranial-lesions-a-case-report
#15
Martin Nicholas Bomalaski, Sean Robinson Smith
Patients with disorders of consciousness (DOC) have profound functional limitations with few treatment options for improving arousal and quality of life. Zolpidem is a nonbenzodiazepine hypnotic used to treat insomnia that has also been observed to paradoxically improve arousal in those with DOC, such as the vegetative or minimally conscious states. Little information exists on its use in patients with DOC who have intracranial space-occupying lesions. We present a case of a 24-year-old man in a minimally conscious states due to central nervous system lymphoma who was observed to have increased arousal and improved motor function after the administration of zolpidem...
January 16, 2017: PM & R: the Journal of Injury, Function, and Rehabilitation
https://www.readbyqxmd.com/read/28079530/can-intoxication-status-be-used-as-a-prediction-tool-for-manner-of-death-a-comparison-of-the-intoxication-status-in-violent-suicides-and-homicides
#16
D Kimberley Molina, Veronica M Hargrove
Determining the manner of death in medicolegal death investigations can be difficult. The investigator relies on many facets of death investigation, including the circumstances of death and autopsy examination. A study was designed to analyze whether the intoxication status of the decedent could be used as another tool in death investigations. The intoxication status of violent (nonoverdose or poisoning) suicides and homicides was retrospectively reviewed and compared. A total of 625 deaths were identified, including 366 suicides and 259 homicides...
March 2017: American Journal of Forensic Medicine and Pathology
https://www.readbyqxmd.com/read/28077205/impact-of-pharmacists-in-optimizing-geriatric-pharmacotherapy-in-primary-care-within-a-veterans-affairs-medical-center
#17
Taryn B Mondiello, Lauren A Stutzman
OBJECTIVE: To assess pharmacists' impact on optimizing pharmacotherapy among geriatric patients. DESIGN: Single-site, prospective, quality-improvement project. SETTING: Primary care at a Veterans Affairs medical center. PARTICIPANTS: Thirteen males 75 years of age and older were included. INTERVENTIONS: Recommendations were made by pharmacists to optimize prescribing. MAIN OUTCOME MEASURES: Differences between specific instances of suboptimal prescribing before and after pharmacists' recommendations, the percentage of pharmacists' recommendations accepted, and the top most commonly prescribed psychotropic medications and their most common indications...
January 1, 2017: Consultant Pharmacist: the Journal of the American Society of Consultant Pharmacists
https://www.readbyqxmd.com/read/28075519/an-update-of-management-of-insomnia-in-patients-with-chronic-orofacial-pain
#18
REVIEW
Galit Almoznino, Yaron Haviv, Yair Sharav, Rafael Benoliel
In this review we discuss the management of chronic orofacial pain (COFP) patients with insomnia. Diagnostic work-up and follow-up routines of COFP patients should include assessment of sleep problems. Management is based on a multidisciplinary approach, addressing the factors that modulate the pain experience as well as insomnia and including both non-pharmacological and pharmacological modalities. Parallel to treatment, patients should receive therapy for co-morbid medical and psychiatric disorders, and possible substance abuse that may be that may trigger or worsen the COFP and/or their insomnia...
January 11, 2017: Oral Diseases
https://www.readbyqxmd.com/read/28067201/false-negative-on-a-proven-involuntary-intoxication-in-two-children-with-lorazepam
#19
Catherine Feliu, Hélène Guillemin, Claire Gozalo, Aurélie Fouley, Hélène Marty, Hervé Millart, Zoubir Djerada
Children aged between 1 to 4 years are the most at risk of unintentional poisonings. Benzodiazepines are the most medicine often cause of the poisoning. Among the twenty-two most prescribed benzodiazepines in France, lorazepam ranks fifth behind zolpidem, alprazolam, bromazepam and zopiclone. However the automated assay currently available does not allow to detect and/or to quantify lorazepam. The alternative to the immunoassay is the liquid chromatography coupled with mass spectrometry (HPLC/MS). This technique, highly sensitive and specific, requires a pre-treatment phase and a good technical proficiency, justifying specialized staff...
February 1, 2017: Annales de Biologie Clinique
https://www.readbyqxmd.com/read/28067180/dispensing-patterns-of-anxiolytics-and-sedative-hypnotics-a-feasibility-study-comparing-datasets-from-a-developed-and-developing-country-australia-and-south-africa
#20
Therése Kairuz, Ilse Truter, Laurence Rossato, Alex Pudmenzky
BACKGROUND: Dispensing patterns reflect drug usage trends. Benzodiazepines are known as drugs with potential for misuse, and frequent dispensing may be a surrogate marker of misuse. OBJECTIVE: The primary aim of this study was to obtain a comparative snapshot of anxiolytic and sedative-hypnotic dispensing in a developing country and a developed country, to determine whether further research about benzodiazepines is warranted. METHOD: A cross-national, cross-sectional retrospective drug utilisation study was conducted on benzodiazepines and z-drugs...
January 9, 2017: Current Drug Safety
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