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Background and objectives: The association between hypnotic drugs and risk of cancer remains controversial. Therefore, we performed a meta-analysis to investigate this association. Materials and Methods: Pubmed and Embase were searched systematically to identify publications up to April 2020. The Newcastle-Ottawa scale for observational studies was used to assess the quality of studies. All included studies were evaluated by two reviewers independently; any discrepancies were resolved through discussion. Results: Twenty-eight studies including 22 case-control studies and 6 cohort studies with 340,614 hypnotics users and 1,828,057 non-users were included in the final analyses. Hypnotics (benzodiazepines and Z-drugs) use was significantly associated with an increased risk of cancer (odds ratio [OR] or relative risk [RR] 1.17; 95% confidence interval 1.09-1.26) in a random-effects meta-analysis of all studies. Subgroup meta-analysis by anxiolytics/sedatives effect (anxiolytics benzodiazepines vs. sedatives group (include sedatives benzodiazepines and Z-drugs)) revealed that a significant association in sedatives group (pooled OR/RR 1.26, 95% CI, 1.10-1.45), whereas no significant relationship was observed in anxiolytics benzodiazepines (pooled OR/RR 1.09, 95% CI, 0.95-1.26). Moreover, a significant dose-response relationship was observed between the use of hypnotics and the risk of cancer. Conclusions: This meta-analysis revealed association between use of hypnotics drugs and risk of cancer. However, the use of lower dose hypnotics and shorter duration exposed to hypnotics seemed to be not associated with an increased risk of cancer. Moreover, the use of anxiolytics effect benzodiazepines seemed to be lower risk than sedatives benzodiazepines. A high heterogeneity was observed among identified studies, and results were inconsistent in some subgroups. Randomized control trials are needed to confirm the findings in the future.
Suvorexant is a novel dual orexin receptor antagonist (DORA) newly introduced in the U.S. as a hypnotic, but no claim of superiority over other hypnotics has been offered. The manufacturer argued that the 5 and 10 mg starting doses recommended by the FDA might be ineffective. The manufacturer's main Phase III trials had not even included the 10 mg dosage, and the 5 mg dosage had not been tested at all in registered clinical trials at the time of approval. Popular alternative hypnotics may be similarly ineffective, since the FDA has also reduced the recommended doses for zolpidem and eszopiclone. The "not to exceed" suvorexant dosage of 20 mg does slightly increase sleep. Because of slow absorption, suvorexant has little effect on latency to sleep onset but some small effect in suppressing wakening after sleep onset and in improving sleep efficiency. The FDA would not approve the manufacturer's preferred 40 mg suvorexant dosage, because of concern with daytime somnolence, driving impairment, and possible narcolepsy-like symptoms. In its immediate benefits-to-risks ratio, suvorexant is unlikely to prove superior to currently available hypnotics-possibly worse-so there is little reason to prefer over the alternatives this likely more expensive hypnotic less-tested in practice. Associations are being increasingly documented relating hypnotic usage with incident cancer, with dementia risks, and with premature death. There is some basis to speculate that suvorexant might be safer than alternative hypnotics in terms of cancer, dementia, infections, and mortality. These safety considerations will remain unproven speculations unless adequate long-term trials can be done that demonstrate suvorexant advantages.
Etomidate is a hypnotic agent that is used for the induction of anesthesia. It produces its effect by acting as a positive allosteric modulator on the γ-aminobutyric acid type A receptor and thus enhancing the effect of the inhibitory neurotransmitter γ-aminobutyric acid. Etomidate stands out among other anesthetic agents by having a remarkably stable cardiorespiratory profile, producing no cardiovascular or respiratory depression. However, etomidate suppresses the adrenocortical axis by the inhibition of the enzyme 11β-hydroxylase. This makes the drug unsuitable for administration by a prolonged infusion. It also makes the drug unsuitable for administration to critically ill patients. Etomidate has relatively large volumes of distributions and is rapidly metabolized by hepatic esterases into an inactive carboxylic acid through hydrolyzation. Because of the decrease in popularity of etomidate, few modern extensive pharmacokinetic or pharmacodynamic studies exist. Over the last decade, several analogs of etomidate have been developed, with the aim of retaining its stable cardiorespiratory profile, whilst eliminating its suppressive effect on the adrenocortical axis. One of these molecules, ABP-700, was studied in extensive phase I clinical trials. These found that ABP-700 is characterized by small volumes of distribution and rapid clearance. ABP-700 is metabolized similarly to etomidate, by hydrolyzation into an inactive carboxylic acid. Furthermore, ABP-700 showed a rapid onset and offset of clinical effect. One side effect observed with both etomidate and ABP-700 is the occurrence of involuntary muscle movements. The origin of these movements is unclear and warrants further research.
Use of benzodiazepines (BZ) and related drugs is subject to considerable debate due to problems with dependency and adverse events. We aimed to describe and compare their use across the Nordic countries. Data on the use of clonazepam, BZ-sedatives, BZ-hypnotics, and benzodiazepine-related drugs (BZRD) in adults (≥20 years) were obtained from nationwide registers in Denmark, Finland, Iceland, Norway, and Sweden, 2000-2020. Main measures were therapeutic intensity (TI:DDD/1000 inhabitants [inhab.]/day) and annual prevalence (users/1000 inhab./year). Overall, TI of BZ and related drugs decreased in all Nordic countries from 2004 to 2020. However, there were considerable differences between countries in TI. In 2020, the TI of BZ and related drugs ranged from 17 DDD/1000 inhab./day in Denmark to 93 DDD/1000 inhab./day in Iceland. BZRD accounted for 55-78% of BZ use in 2020, followed by BZ sedatives at 20-44%, BZ-hypnotics at <1-5%, and clonazepam at <1-2%. Annual prevalence of BZ use increased with age in all countries, and the highest annual prevalence was observed among people ≥80 years. Overall, the use of BZ and related drugs has decreased in all Nordic countries from 2004 to 2020, however, with considerable differences in their use between countries. The highest prevalence was observed among the oldest age groups-despite warnings against their use in this population.
Psychiatric drugs released by humans in wastewater have received more attention because of their potential risks for aquatic organisms. In this study, the occurrence of the two most common groups of psychiatric drugs (sedatives-hypnotics-anxiolytics and antidepressants) were evaluated in the Tehran South Municipal Wastewater Treatment Plant. All the target sedatives-hypnotics-anxiolytics (alprazolam, phenobarbital, and thioridazine) and antidepressants (fluoxetine, citalopram, sertraline, and venlafaxine) were observed in influent and secondary clarification (SC) effluent. Thioridazine (164.25 ± 218.74 ng/L) and citalopram (672.53 ± 938.56 ng/L) had the highest mean concentrations in the influent, while alprazolam (5.09 ± 2.33 ng/L) and citalopram (776.97 ± 1088.01 ng/L) had the highest concentrations in the SC effluent. The higher concentrations of the psychiatric drugs, except thioridazine, were detected in the SC effluent compared to the concentrations in the influent. The increased drugs concentrations, with negative removal efficiencies, were more distinctive in the cold season samples. Psychiatric drugs processed in the chlorination unit followed a completely different pattern compared to the drugs in the biological treatment unit. All the drugs' concentrations, except thioridazine, decreased in the chlorination unit, ranging between 27 ± 14% for alprazolam and 75 ± 10% for citalopram. However, the mean concentrations of the detected drugs were as follows: sertraline (11.96 ± 11.62 ng/L) and venlafaxine (184.94 ± 219.74 ng/L) which could cause environmental and ecological concerns.
Misuse of psychoactive medicines, especially prescription opioids, but also benzodiazepines, hypnotics and sedatives, has become a significant public health issue in some countries, especially in the USA, where it has been extensively documented, as well as in Canada and Australia. However, in the European Union (EU) published literature on the topic is scarce and heterogeneous regarding definitions, sources of data, tools and methods of analysis.The aim of this scoping review is to map the key concepts on psychoactive medicines' misuse and examine the existing body of evidence on this topic in the EU. Data on the possible consequences of medicines' misuse-adverse drug reactions, poisonings, hospitalisations and deaths-will also be analysed.
Type A γ-aminobutyric acid receptors (GABAARs) are the principal inhibitory receptors in the brain and the target of a wide range of clinical agents, including anaesthetics, sedatives, hypnotics and antidepressants1-3. However, our understanding of GABAAR pharmacology has been hindered by the vast number of pentameric assemblies that can be derived from 19 different subunits4 and the lack of structural knowledge of clinically relevant receptors. Here, we isolate native murine GABAAR assemblies containing the widely expressed α1 subunit and elucidate their structures in complex with drugs used to treat insomnia (zolpidem (ZOL) and flurazepam) and postpartum depression (the neurosteroid allopregnanolone (APG)). Using cryo-electron microscopy (cryo-EM) analysis and single-molecule photobleaching experiments, we uncover three major structural populations in the brain: the canonical α1β2γ2 receptor containing two α1 subunits, and two assemblies containing one α1 and either an α2 or α3 subunit, in which the single α1-containing receptors feature a more compact arrangement between the transmembrane and extracellular domains. Interestingly, APG is bound at the transmembrane α/β subunit interface, even when not added to the sample, revealing an important role for endogenous neurosteroids in modulating native GABAARs. Together with structurally engaged lipids, neurosteroids produce global conformational changes throughout the receptor that modify the ion channel pore and the binding sites for GABA and insomnia medications. Our data reveal the major α1-containing GABAAR assemblies, bound with endogenous neurosteroid, thus defining a structural landscape from which subtype-specific drugs can be developed.
Delirium is an acute neuropsychiatric syndrome characterized by altered levels of attention and awareness with cognitive deficits. It is most prevalent in elderly hospitalized patients and related to poor outcomes. Predisposing risk factors, such as older age, determine the baseline vulnerability for delirium, while precipitating factors, such as use of sedatives, trigger the syndrome. Risk factors are heterogeneous and the underlying biological mechanisms leading to vulnerability for delirium are poorly understood. We tested the hypothesis that delirium and its risk factors are associated with consistent brain network changes. We performed a systematic review and qualitative meta-analysis and included 126 brain network publications on delirium and its risk factors. Findings were evaluated after an assessment of methodological quality, providing N=99 studies of good or excellent quality on predisposing risk factors, N=10 on precipitation risk factors and N=7 on delirium. Delirium was consistently associated with functional network disruptions, including lower EEG connectivity strength and decreased fMRI network integration. Risk factors for delirium were associated with lower structural connectivity strength and less efficient structural network organization. Decreased connectivity strength and efficiency appear to characterize structural brain networks of patients at risk for delirium, possibly impairing the functional network, while functional network disintegration seems to be a final common pathway for the syndrome.
Background: Drug package inserts (PIs) are the most accessible source of information for users and are designed to aid the safe use of medicines and avert adverse events. This study measured the conformity of PIs with the health communications standards of Iran's Food and drug Administration (FDA). Methods: This descriptive cross-sectional study evaluated 92 PIs related to 22 best-selling neurological and psychiatric drugs in Iran based on criteria approved by Iran's FDA. Six categories of criteria were considered in evaluating the extent of conformity: I) writing and formatting, II) references, III) drug description, IV) warnings and precautions, V) interactions, and VI) side effects. Each PI was scored based on observation of standards; data was analyzed using Microsoft Excel pivot tables. Results: In total, 2929 items from 92 PIs were evaluated, of which 37 (40.2%) were related to antidepressants, 31 (33.7%) to sedatives and hypnotics, and 24 (26%) to anticonvulsant drugs. The PI content was insufficient in various aspects of conformity with standards in each category. Among the six categories, the best match was found in warnings and precautions with 667items (72.5%), followed by writing and formatting with 663 (69.1%). The lowest conformity was found in the reference category with 194 (26.4%) items. Conclusion: The PIs of Iranian neurological drugs do not fully meet Iran's FDA standards. It is strongly recommended that smart PIs be developed using mobile apps to overcome this problem.
Many vegetable extracts, essential oils, and their main constituents are active on the Central Nervous System (CNS). In fact, they have been used as sedatives, hypnotics, or tranquilizers for their activity in treating CNS disorders. In this research, we studied the possible activities of Lavandula angustifolia (LA) essential oil and of its main constituent, linalool, as anti-stress compounds on anxiety and social interaction and their in vitro effects on proteins (pERK and PKA) involved in the transmission of the signal. An acute intraperitoneal injection of linalool (100 mg/kg) and of LA essential oil (200 mg/kg) reduced motor activity without any anxiolytic effect, but significantly increased social interaction. Stressed mice, after being exposed to a social defeat encounter, showed heightened anxiety and social avoidance. Acute administration of LA essential oil blocked stress-induced anxiety, while linalool showed no effects. However, both compounds were capable of reversing social aversion, acting as antidepressant agents. Our results showed that linalool inhibits pERK and PKA expression in the SH-SY5Y cell, but no effect was detected with the LA essential oil. Therefore, the LA essential oil and linalool may be considered as useful alternative tools to the available traditional treatments for social stress-induced mental illnesses.
Type A GABA receptors (GABA A Rs) are the principal inhibitory receptors in the brain and the target of a wide range of clinical agents, including anesthetics, sedatives, hypnotics, and antidepressants. However, our understanding of GABA A R pharmacology has been hindered by the vast number of pentameric assemblies that can be derived from a total 19 different subunits and the lack of structural knowledge of clinically relevant receptors. Here, we isolate native murine GABA A R assemblies containing the widely expressed α 1 subunit, and elucidate their structures in complex with drugs used to treat insomnia (zolpidem and flurazepam) and postpartum depression (the neurosteroid allopregnanolone). Using cryo-EM analysis and single-molecule photobleaching experiments, we uncover only three structural populations in the brain: the canonical α 1 β2γ 2 receptor containing two α 1 subunits and two unanticipated assemblies containing one α 1 and either an α 2 , α 3 or α 5 subunit. Both of the noncanonical assemblies feature a more compact arrangement between the transmembrane and extracellular domains. Interestingly, allopregnanolone is bound at the transmembrane α/β subunit interface, even when not added to the sample, revealing an important role for endogenous neurosteroids in modulating native GABA A Rs. Together with structurally engaged lipids, neurosteroids produce global conformational changes throughout the receptor that modify both the pore diameter and binding environments for GABA and insomnia medications. Together, our data reveal that GABA A R assembly is a strictly regulated process that yields a small number of structurally distinct complexes, defining a structural landscape from which subtype-specific drugs can be developed.
Sleep and related disorders could lead to changes in various brain networks, but little is known about the role of amyloid β (Aβ) burden-a key Alzheimer's disease (AD) biomarker-in the relationship between sleep disturbance and altered resting state functional connectivity (rsFC) in older adults. This cross-sectional study examined the association between sleep disturbance, Aβ burden, and rsFC using a large-scale dataset from the Alzheimer's Disease Neuroimaging Initiative (ADNI). Sample included 489 individuals (53.6% cognitively normal, 32.5% mild cognitive impairment, and 13.9% AD) who had completed sleep measures (Neuropsychiatric Inventory), PET Aβ data, and resting-state fMRI scans at baseline. Within and between rsFC of the Salience (SN), the Default Mode (DMN) and the Frontal Parietal network (FPN) were compared between participants with sleep disturbance versus without sleep disturbance. The interaction between Aβ positivity and sleep disturbance was evaluated using the linear regressions, controlling for age, diagnosis status, gender, sedatives and hypnotics use, and hypertension. Although no significant main effect of sleep disturbance was found on rsFC, a significant interaction term emerged between sleep disturbance and Aβ burden on rsFC of SN (β = 0.11, P = 0.006). Specifically, sleep disturbance was associated with SN hyperconnectivity, only with the presence of Aβ burden. Sleep disturbance may lead to altered connectivity in the SN when Aβ is accumulated in the brain. Individuals with AD pathology may be at increased risk for sleep-related aberrant rsFC; therefore, identifying and treating sleep problems in these individuals may help prevent further disease progression.
Sleep and related disorders could lead to changes in various brain networks, but little is known about the role of amyloid β (Aβ) burden-a key Alzheimer's disease (AD) biomarker-in the relationship between sleep disturbance and altered resting state functional connectivity (rsFC) in older adults. This cross-sectional study examined the association between sleep disturbance, Aβ burden, and rsFC using a large-scale dataset from the Alzheimer's Disease Neuroimaging Initiative (ADNI). Sample included 489 individuals (53.6% cognitively normal, 32.5% mild cognitive impairment, and 13.9% AD) who had completed sleep measures (Neuropsychiatric Inventory), PET Aβ data, and resting-state fMRI scans at baseline. Within and between rsFC of the Salience (SN), the Default Mode (DMN) and the Frontal Parietal network (FPN) were compared between participants with sleep disturbance versus without sleep disturbance. The interaction between Aβ positivity and sleep disturbance was evaluated using linear regressions, controlling for age, diagnosis status, gender, sedatives and hypnotics use, and hypertension. Although no significant main effect of sleep disturbance was found on rsFC, a significant interaction term emerged between sleep disturbance and Aβ burden on rsFC of SN (β=0.11, P=0.006). Specifically, sleep disturbance was associated with SN hyperconnectivity, only with the presence of Aβ burden. Sleep disturbance may lead to altered connectivity in the SN when Aβ is accumulated in the brain. Individuals with AD pathology may be at increased risk for sleep-related aberrant rsFC; therefore, identifying and treating sleep problems in these individuals may help prevent further disease progression.
The prompt diagnosis and initial management of pediatric traumatic brain injury poses many challenges to the emergency department (ED) physician. In this review, we aim to appraise the literature on specific management issues faced in the ED, specifically: indications for neuroimaging, choice of sedatives, applicability of hyperventilation, utility of hyperosmolar agents, prophylactic anti-epileptics, and effect of hypothermia in traumatic brain injury. A comprehensive literature search of PubMed and Embase was performed in each specific area of focus corresponding to the relevant questions. The majority of the head injured patients presenting to the ED are mild and can be observed. Clinical prediction rules assist the ED physician in deciding if neuroimaging is warranted. In cases of major head injury, prompt airway control and careful use of sedation are necessary to minimize the chance of hypoxia, while avoiding hyperventilation. Hyperosmolar agents should be started in these cases and normothermia maintained. The majority of the evidence is derived from adult studies, and most treatment modalities are still controversial. Recent multicenter trials have highlighted the need to establish common platforms for further collaboration.
Fatal intoxication with sedative-hypnotic drugs is increasing yearly. However, the plasma drug concentration data for fatal intoxication involving these substances are not systematic and even overlap with the intoxication group. Therefore, developing a more precise and trustworthy approach to determining the cause of death is necessary. This study analyzed mice plasma and brainstem samples using the liquid chromatography-high resolution tandem mass spectrometry (LC-HR MS/MS)-based metabolomics method to create discriminative classification models for estazolam fatal intoxication (EFI). The most perturbed metabolic pathway between the EFI and EIND (estazolam intoxication non-death) was examined, Both EIND and EFI groups were administered 500 mg of estazolam per 100 g of body weight. Mice that did not die beyond 8 hours were treated with cervical dislocation and were classified into the EIND groups; the lysine degradation pathway was verified by qPCR (Quantitative Polymerase Chain Reaction), metabolite quantitative and TEM (transmission electron microscopy) analysis. Non-targeted metabolomics analysis with EFI were the experimental group and four hypoxia-related non-drug-related deaths (NDRDs) were the control group. Mass spectrometry data were analyzed with Compound Discoverer (CD) 3.1 software and multivariate statistical analyses were performed using the online software MetaboAnalyst 5.0. After a series of analyses, the results showed the discriminative classification model in plasma was composed of three endogenous metabolites: phenylacetylglycine, creatine and indole-3-lactic acid, and in the brainstem was composed of palmitic acid, creatine, and indole-3-lactic acid. The specificity validation results showed that both classification models distinguished between the other four sedatives-hypnotics, with an area under ROC curve (AUC) of 0.991, and the classification models had an extremely high specificity. When comparing different doses of estazolam, the AUC value of each group was larger than 0.80, and the sensitivity was also high. Moreover, the stability results showed that the AUC value was equal to or very close to 1 in plasma samples stored at 4 °C for 0, 1, 5, 10 and 15 days; the predictive power of the classification model was stable within 15 days. The results of lysine degradation pathway validation revealed that the EFI group had the highest lysine and saccharopine concentrations (mean (ng/mg) = 1.089 and 1.2526, respectively) when compared to the EIND and control group, while the relative expression of SDH (saccharopine dehydrogenase) showed significantly lower in the EFI group (mean = 1.206). Both of these results were statistically significant. Furthermore, TEM analysis showed that the EFI group had the more severely damaged mitochondria. This work gives fresh insights into the toxicological processes of estazolam and a new method for identifying EFI-related causes of mortality.
Procedural sedation and analgesia outside the operating theater have become standard care in managing pain and anxiety in children undergoing diagnostic and therapeutic procedures. The objectives of this study are to describe the current pediatric procedural sedation and analgesia practice patterns in European emergency departments, to perform a needs assessment-like analysis, and to identify barriers to implementation. A survey study of European emergency departments treating children was conducted. Through a lead research coordinator identified through the Research in European Pediatric Emergency Medicine (REPEM) network for each of the participating countries, a 30-question questionnaire was sent, targeting senior physicians at each site. Descriptive statistics were performed. One hundred and seventy-one sites participated, treating approximately 5 million children/year and representing 19 countries, with a response rate of 89%. Of the procedural sedation and analgesia medications, midazolam (100%) and ketamine (91%) were available to most children, whereas propofol (67%), nitrous oxide (56%), intranasal fentanyl (47%), and chloral hydrate (42%) were less frequent. Children were sedated by general pediatricians in 82% of cases. Safety and monitoring guidelines were common (74%), but pre-procedural checklists (51%) and capnography (46%) less available. In 37% of the sites, the entire staff performing procedural sedation and analgesia were certified in pediatric advanced life support. Pediatric emergency medicine was a board-certified specialty in 3/19 countries. Physician (73%) and nursing (72%) shortages and lack of physical space (69%) were commonly reported as barriers to procedural sedation and analgesia. Nurse-directed triage protocols were in place in 52% of the sites, mostly for paracetamol (99%) and ibuprofen (91%). Tissue adhesive for laceration repair was available to 91% of children, while topical anesthetics for intravenous catheterization was available to 55%. Access to child life specialists (13%) and hypnosis (12%) was rare.Conclusion: Procedural sedation and analgesia are prevalent in European emergency departments, but some sedation agents and topical anesthetics are not widely available. Guidelines are common but further safety nets, nurse-directed triage analgesia, and nonpharmacologic support to procedural sedation and analgesia are lacking. Barriers to implementation include availability of sedation agents, staff shortage, and lack of space. What is Known: • Effective and prompt analgesia, anxiolysis, and sedation (PSA) outside the operating theatre have become standard in managing pain and anxiety in children undergoing painful or anxiogenic diagnostic and therapeutic procedures. • We searched PubMed up to September 15, 2020, without any date limits or language restrictions, using different combinations of the MeSH terms "pediatrics," "hypnotics and sedatives," "conscious sedation," and "ambulatory surgical procedures" and the non-MeSH term "procedural sedation" and found no reports describing the current practice of pediatric PSA in Europe. What is New: • This study is, to the best of our knowledge, the first to shed light on the pediatric PSA practice in European EDs and uncovers important gaps in several domains, notably availability of sedation medications and topical anesthetics, safety aspects such as PSA provider training, availability of nonpharmacologic support to PSA, and high impact interventions such as nurse-directed triage analgesia. • Other identified barriers to PSA implementation include staff shortage, control of sedation medications by specialists outside the emergency department, and lack of space.
Depression affects approx. 4% of the global population and is often accompanied by insomnia. Medications used to treat insomnia can have side effects such as development of tolerance and addiction. The Protac Ball Blanket™ (PBB) is a non-pharmacological supplement to sedatives and hypnotics, but evidence for the efficacy of PBB is needed before the treatment is implemented. The objective of this trial is to test the efficacy of PBB on insomnia caused by depression in a randomized controlled design.
The purpose of this systematic review is to summarize information about the impact different classes of medications and polypharmacy have on recurrent falls, defined as two or more falls in a 12-month period, in community-dwelling older adults. After adjustment for confounders such as age, gender, weight or depression symptoms, the reviewed studies suggested that older adults who use antidepressants, sedatives or hypnotics and anti-epileptics were more likely to experience recurrent falls than non-users. Polypharmacy (use of four or more prescription medications daily) caused 1.5-2 times higher possibility of recurrent falls in older adults. As a high-risk group, recurrent fallers require meaningful intervention. Medications are believed to be a modifiable risk factor in falls prevention; hence, special consideration should be taken to balance the benefit and harm in initiating, continuing or increasing certain classes of medications in elderly recurrent fallers.
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