Abstract:
:Insomnia is a heterogeneous, highly prevalent condition that is associated with a high level of psychiatric, physical, social and economic morbidity. The treatment of insomnia involves pharmacological and non-pharmacological interventions. The mainstay of pharmacological treatment of insomnia has been the benzodiazepines, the introduction of which represented a significant improvement over the barbiturates and chloral hydrate. Although benzodiazepines have been shown to be efficacious in treating insomnia, they have also been associated with a number of adverse effects including tolerance, dependence, withdrawal and abuse potential, impairment in daytime cognitive and psychomotor performance (including an increased risk of accidents and falls), adverse effects on respiration and the disruption of normal sleep architecture with reduction in both slow wave sleep and rapid eye movement. In the last decade, the treatment of insomnia has been supplemented by the introduction of a number of non-benzodiazepine hypnotics including zolpidem, zopiclone and, most recently, zaleplon. Zaleplon possesses a unique pharmacological profile, with an ultra-short half-life of about 1 hour, and selective binding to the BZ1(omega1) receptor subtypes of the GABA(A) receptor. This unique pharmacological profile predicts a number of pharmacodynamic properties that account for a unique benefit-risk profile. Consistent with these predictions, zaleplon has been shown in a number of studies to be efficacious in promoting sleep initiation, but less so in promoting sleep maintenance. The adverse effects associated with zaleplon have been shown to be more rapidly resolved and/or lesser in magnitude than those associated with benzodiazepines (including triazolam) and the longer acting non-benzodiazepine hypnotics (zolpidem and zopiclone). This improved risk profile includes: the effects of zaleplon on psychomotor and cognitive performance; tolerance, withdrawal and rebound; respiratory depression; sleep architecture; and other treatment-emergent adverse effects. The unique benefit-risk profile of this agent may be particularly suitable for certain patients with insomnia and provides yet another option in the management of this impairing condition.
journal_name
Drug Safjournal_title
Drug safetyauthors
Barbera J,Shapiro Cdoi
10.2165/00002018-200528040-00003keywords:
subject
Has Abstractpub_date
2005-01-01 00:00:00pages
301-18issue
4eissn
0114-5916issn
1179-1942pii
2843journal_volume
28pub_type
杂志文章,评审相关文献
DRUG SAFETY文献大全abstract::While classifications into generations according to antimicrobial activity has helped clinicians incorporate the increasing number of cephalosporins into their pharmacological repertoire, adverse effects among the different agents fail to follow similar categories. In general, cephalosporins are fairly well tolerated ...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-199309020-00005
更新日期:1993-08-01 00:00:00
abstract::Drug eruptions are among the most common adverse drug reactions, affecting approximately 3% of hospitalised patients. Although the rate of severe cutaneous adverse reactions to medications is low, these reactions can affect anyone who takes medication, and can result in death or disability. Two general patterns can be...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-200730110-00003
更新日期:2007-01-01 00:00:00
abstract:INTRODUCTION:Although the mortality risk associated with tramadol use in children has triggered the revision of tramadol drug labeling, the mortality risk in adults has not been thoroughly explored. OBJECTIVE:The objective of this study was to evaluate whether tramadol use is associated with mortality in various risk ...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.1007/s40264-018-00786-y
更新日期:2019-06-01 00:00:00
abstract::Epidural analgesia for caesarean section is increasingly used and is gradually replacing general anaesthesia. Hypotension is one of the main risks: preloading of the maternal circulation is used to prevent maternal hypotension and its consequences. For this, various colloid and crystalloid solutions are used. We repor...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.2165/00002018-199207010-00008
更新日期:1992-01-01 00:00:00
abstract:BACKGROUND:The tumour necrosis factor-alpha inhibitor infliximab is incorporated in the treatment guidelines for patients with inflammatory bowel disease (IBD). However, concerns about serious adverse events such as infections, malignancies and death do exist. OBJECTIVE:To evaluate the occurrence of serious events of ...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.2165/0002018-200831120-00009
更新日期:2008-01-01 00:00:00
abstract::Osteoporosis is the most frequent metabolic condition experienced by elderly individuals. It is characterised by a low bone mass and microarchitectural deterioration of bone tissue leading to an increase in bone fragility and susceptibility to fracture. Osteoporosis constitutes a significant financial burden for healt...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-199819020-00005
更新日期:1998-08-01 00:00:00
abstract:INTRODUCTION:Gastric acid-related symptoms are highly prevalent in the general population (21-40%), and more than 11% of individuals use medication for the treatment of these symptoms. The uptake of micronutrients is dependent on the gastrointestinal potential of hydrogen (pH). OBJECTIVE:We hypothesized that medicatio...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.1007/s40264-016-0488-8
更新日期:2017-03-01 00:00:00
abstract::A number of affluent countries are moving to eliminate thiomersal (thimerosal), an ethylmercury preservative, from vaccines as a precautionary measure because of concerns about the potential adverse effects of mercury in infants. The WHO advocates continued use of thiomersal-containing vaccines in developing countries...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-200528020-00001
更新日期:2005-01-01 00:00:00
abstract::Nonsteroidal anti-inflammatory drugs (NSAIDs) are frequently prescribed to women of child-bearing age. Three case series highlight the possibility of a link between NSAIDs and reversible infertility. The pharmacological target of NSAIDs is cyclo-oxygenase (COX), which catalyses the first rate-limiting step in the prod...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-200225080-00001
更新日期:2002-01-01 00:00:00
abstract::Zopiclone is a cyclopyrrolone hypnosedative that is chemically unrelated to the benzodiazepines but nevertheless potentiates gamma-aminobutyric acid-mediated neuronal inhibition, and has demonstrated proven efficacy and good tolerability in the treatment of insomnia over 15 years of use. Zopiclone is indicated for sho...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-199921060-00003
更新日期:1999-12-01 00:00:00
abstract::Cholinesterase inhibitors are currently the most established treatment strategy in Alzheimer's disease. The treatment effect appears mainly to be symptomatic. Effects on progression of the disease following long term treatment, and possible neuroprotective effects, have been investigated. Delay until nursing home plac...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-199819060-00004
更新日期:1998-12-01 00:00:00
abstract::Although inhaled and intranasal corticosteroids are first-line therapy for asthma and allergic rhinitis, there has recently been an increasing awareness of their propensity to produce systemic adverse effects. The availability of more potent and lipophilic corticosteroids and new chlorofluorocarbon (CFC)-free formulat...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-200023010-00002
更新日期:2000-07-01 00:00:00
abstract:BACKGROUND:Automated disproportionality analysis of spontaneous reporting is increasingly used routinely. It can theoretically be influenced by a competition bias for signal detection owing to the presence of reports related to well-established drug-event associations. OBJECTIVE:The aim of the study was to explore the...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.1007/BF03261981
更新日期:2012-10-01 00:00:00
abstract:INTRODUCTION:Non-steroidal anti-inflammatory drugs are associated with a dose and duration-dependent coronary risk. There is little information concerning analgesic-dose ibuprofen, among the most widely used drugs worldwide. OBJECTIVE:Our objective was to measure the risks of acute coronary syndrome (ACS) after dispen...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.1007/s40264-018-0686-7
更新日期:2018-11-01 00:00:00
abstract::Benefit-risk assessment should be ongoing during the life cycle of a pharmaceutical agent. New products are subjected to rigorous registration laws and rules, which attempt to assure the availability and validity of evidence. For older products, bias in benefit-risk assessment is more likely, as a number of safeguards...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.2165/00002018-200932040-00003
更新日期:2009-01-01 00:00:00
abstract:INTRODUCTION:Pharmacovigilance includes analysis of large databases of information on drugs and events using algorithms that detect disproportional frequencies of associations. In order to test such algorithms, attempts have been made to provide canonical reference lists of so-called 'positive controls' and 'negative c...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.1007/s40264-016-0392-2
更新日期:2016-05-01 00:00:00
abstract::The risks and adverse effects of the low dose, new generation progestogen combined oral contraceptives (COCs) are much lower than original studies involving pills containing 50 micrograms estrogen. The main effects are those on the cardiovascular system, lipid and glucose metabolism and cancer. Any effect of the COC o...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-199512020-00002
更新日期:1995-02-01 00:00:00
abstract:INTRODUCTION:Previously, an app has been developed for healthcare professionals (HCPs) and patients to report adverse drug reactions (ADRs) to national medicines agencies and to receive drug safety information. OBJECTIVE:This study aimed to assess (1) European HCPs' and patients' interest in an app for this two-way ri...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.1007/s40264-018-0648-0
更新日期:2018-07-01 00:00:00
abstract:BACKGROUND:It has been shown that the abrupt cessation of treatment with beta-adrenoceptor antagonists (beta-blockers) increases the risk of myocardial infarction in patients with hypertension. As beta-blockers differ in their pharmacokinetic and pharmacodynamic properties, this risk of discontinuation might also diffe...
journal_title:Drug safety
pub_type: 临床试验,杂志文章
doi:10.2165/00002018-200730060-00008
更新日期:2007-01-01 00:00:00
abstract::Monobactams and carbapenems are 2 classes of beta-lactam antibiotics that were introduced in the 1980s. This review considers the monobactam aztreonam and the carbapenems imipenem and meropenem. Imipenem is administered together with cilastatin, which inhibits the enzymatic breakdown of imipenem in the kidney. The ant...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-199512050-00003
更新日期:1995-05-01 00:00:00
abstract:INTRODUCTION:The epidemiology of naturally occurring intussusception is known to increase significantly between the ages of 3 and 8 months. Post-licensure studies have reported a fivefold and twofold increase in intussusception in the first week after the first dose and second dose, respectively, of current rotavirus v...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.1007/s40264-016-0424-y
更新日期:2016-08-01 00:00:00
abstract:BACKGROUND:Medication-related adverse events (MRAEs) form a large proportion of all adverse events in hospitalized patients and are associated with considerable preventable harm. Detailed information on harm related to drugs administered during hospitalization is scarce. Knowledge of the nature and preventability of MR...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.2165/11536800-000000000-00000
更新日期:2010-10-01 00:00:00
abstract:BACKGROUND:Examination of clinical data routinely recorded in general practice provides significant opportunities for identifying and quantifying medicine-related adverse events not captured by spontaneous adverse reaction reporting systems. Robust pharmacovigilance methods for detecting and monitoring adverse events d...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.1007/BF03261970
更新日期:2012-09-01 00:00:00
abstract::It is a major clinical and public health problem that there is no clear strategy as to how we best make use of information obtained when pregnant women take drugs. For this reason, some pregnant women are not treated as they should be and some are given drugs they should not use. We suggest a monitoring system that co...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.2165/00002018-200225010-00003
更新日期:2002-01-01 00:00:00
abstract::The most frequently reported symptoms in heart failure are fatigue and dyspnoea, which limit exercise tolerance. However, several surveys reveal other changes in physical and psychological well-being which affect the patient's perception of 'quality of life'. The introduction of new treatments for heart failure has st...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-199106040-00002
更新日期:1991-07-01 00:00:00
abstract:BACKGROUND:The use of data mining has increased among regulators and pharmaceutical companies. The incremental value of data mining as an adjunct to traditional pharmacovigilance methods has yet to be demonstrated. Specifically, the utility in identifying new safety signals and the resources required to do so have not ...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.2165/11319000-000000000-00000
更新日期:2010-02-01 00:00:00
abstract::Neuropsychiatric adverse effects related to potent antiretroviral therapy are among the complications that can lead to poor adherence, treatment interruptions, or change of antiretroviral therapy regimens. For a historical perspective, we review early literature and case reports with CNS adverse effects attributed to ...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-200629100-00004
更新日期:2006-01-01 00:00:00
abstract::Drug-induced QT interval prolongation is now a major concern in safety pharmacology. Regulatory authorities such as the US FDA and the European Medicines Agency require in vitro testing of all drug candidates against the potential risk for QT interval prolongation prior to clinical trials. Common in vitro methods incl...
journal_title:Drug safety
pub_type: 杂志文章,评审
doi:10.2165/00002018-200427110-00002
更新日期:2004-01-01 00:00:00
abstract:BACKGROUND:Although systems to collect information about suspected adverse drug reactions (ADRs) were established in many countries and by the WHO in the 1960s, few studies have examined reported ADRs related to national income. OBJECTIVE:The aim of the study was to characterize ADRs reported to the WHO-ADR database, ...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.1007/BF03262002
更新日期:2012-12-01 00:00:00
abstract:BACKGROUND:Following reports of sudden death in patients taking medication to treat attention-deficit hyperactivity disorder (ADHD), this study aimed to identify cases of death in patients prescribed stimulants and atomoxetine and to determine any association between these and sudden death. METHOD:The UK General Pract...
journal_title:Drug safety
pub_type: 杂志文章
doi:10.2165/11317630-000000000-00000
更新日期:2009-01-01 00:00:00