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1.
Epidemiol. serv. saúde ; 31(1): e2021347, 2022. tab, graf
Article in English, Portuguese | LILACS | ID: biblio-1375395

ABSTRACT

Objetivo: Verificar a prevalência e fatores associados ao uso de medicamento indutor do sono entre mulheres assistidas na Atenção Primária à Saúde (APS), Vitória, ES, Brasil. Métodos: Estudo transversal com mulheres de 20-59 anos, realizado em 2014. Analisou-se a associação do uso de indutor do sono com fatores socioeconômicos e experiências de violência (regressão de Poisson). Resultados: Entre 991 participantes, 18,5% usavam medicamento indutor do sono e 45,9% usaram-no alguma vez na vida. Seu uso, atualmente e ao longo da vida, associou-se a idade, escolaridade e violências psicológica, física e sexual no último ano (p-valor<0,05). Menor renda familiar (RP=1,30; IC95% 1,03;1,64) e parceiro controlador (RP=1,35; IC95% 1,08;1,69) associaram-se ao uso atual, enquanto experiência de violência sexual na infância (RP=1,33; IC95% 1,13;1,56) associou-se ao uso alguma vez na vida. Conclusão: O uso de medicamento indutor do sono foi frequente entre usuárias da APS, associando-se a fatores socioeconômicos e experiências de violência.


Objetivo: Verificar la prevalencia y los factores asociados al uso de medicamentos inductores del sueño en mujeres en la Atención Primaria de Salud (APS) de Vitória, ES, Brasil. Métodos: Estudio transversal con mujeres de 20 a 59 años realizado en 2014. Se analizó la asociación del uso de inductores del sueño con factores socioeconómicos y violencia (regresión de Poisson). Resultados: Entre las 991 participantes, 18,5% usó medicamentos inductores y 45,9% los había usado en algún momento. El uso, actual y en la vida, de estos medicamentos se asoció con la edad, años de educación, violencia psicológica, física y sexual en el último año (p-valor<0,05). Ingresos familiares bajos (RP=1,30; IC95% 1,03;1,64) y pareja controladora (RP=1,35; IC95% 1,08;1,69) se asociaron con el uso actual, mientras que la experiencia de violencia en la infancia (RP=1,33; IC95% 1,13;1,56) se asoció con el uso alguna vez en la vida. Conclusión: El uso de inductores del sueño fue frecuente entre usuarias de la APS, asociado a factores socioeconómicos y violencia.


Objective: To verify prevalence and factors associated with the use of sleep-inducing medication among women receiving primary health care (PHC) in Vitória, ES, Brazil. Methods: This was a cross-sectional study conducted in 2014 with women aged 20-59. We analyzed association of sleep-inducing medication use with socioeconomic factors and experiences of violence (Poisson regression). Results: Out of 991 participants, 18.5% were using sleep-inducing medication and 45.9% had used it at some point in their lives. Current and lifetime use of these medications was associated with age, years of education, as well as psychological, physical and sexual violence in the last year (p-valor<0,05). Lower family income (PR=1.30; 95%CI 1.03;1.64) and controlling partner (PR=1.35; 95%CI 1.08;1.69) were associated with current use, while experience of sexual violence in childhood (PR=1.33; 95%CI 1.13;1.56) was associated with lifetime use. Conclusion: Use of sleep-inducing medication was frequent among PHC service users, and was associated with socioeconomic factors and experiences of violence.


Subject(s)
Humans , Female , Adult , Middle Aged , Young Adult , Sleep/physiology , Violence Against Women , Sleep Aids, Pharmaceutical/administration & dosage , Socioeconomic Factors , Mental Health , Observational Study
2.
J Fam Pract ; 70(9): E1-E2, 2021 11.
Article in English | MEDLINE | ID: mdl-34818157

ABSTRACT

► Chronic insomnia ► Nightly zolpidem use ► Concern for tapering withdrawals.


Subject(s)
Sleep Aids, Pharmaceutical/administration & dosage , Sleep Initiation and Maintenance Disorders/drug therapy , Zolpidem/administration & dosage , Drug Administration Schedule , Humans , Male , Middle Aged , Treatment Outcome
3.
Clin Transl Gastroenterol ; 12(8): e00396, 2021 08 03.
Article in English | MEDLINE | ID: mdl-34342302

ABSTRACT

INTRODUCTION: Preclinical evidence suggests that melatonin may affect cellular pathways involved in colorectal cancer (CRC). We sought to test whether melatonin use was associated with decreased risk of CRC using population-based data. METHODS: We performed a nationwide cohort study using a new-user study design. We identified a total of 58,657 incident melatonin users aged 50 years and older from the Prescribed Drug Register, and matched them with 175,971 comparisons who did not use melatonin, on the ratio of 1:3. The Cox regression model was used to calculate hazard ratios and 95% confidence intervals. RESULTS: The incidence rate of CRC was 10.40 per 10,000 person-years for melatonin users, whereas the rate was 12.82 per 10,000 person-years in the nonusers. We found a significant negative association between melatonin use and risk of CRC (adjusted hazard ratio, 0.82; 95% confidence interval, 0.72-0.92). A test for trend showed a significant dose-response correlation (P < 0.001). The decrease of CRC risk was independent of tumor location and stage at diagnosis. When stratified by age groups, the inverse association was significant only among individuals aged 60 years and older. DISCUSSION: This population-based cohort study suggests that the use of melatonin was associated with a reduced risk of CRC. Further studies are needed to confirm the observed association and to explore the underlying mechanisms.


Subject(s)
Colorectal Neoplasms/epidemiology , Melatonin/administration & dosage , Sleep Aids, Pharmaceutical/administration & dosage , Aged , Antineoplastic Agents/administration & dosage , Colorectal Neoplasms/prevention & control , Female , Humans , Incidence , Male , Middle Aged , Proportional Hazards Models , Retrospective Studies , Risk Factors , Sensitivity and Specificity , Sleep Quality , Sweden/epidemiology
5.
J Clin Psychopharmacol ; 41(4): 414-420, 2021.
Article in English | MEDLINE | ID: mdl-34181362

ABSTRACT

PURPOSE/BACKGROUND: This study was designed as an early assessment of the safety of the orexin receptor antagonist suvorexant, but also included exploratory assessments of balance and psychomotor performance that are the focus of this report. METHODS/PROCEDURES: This was a double-blind, randomized, 3-period, crossover, phase 1 study. Balance and psychomotor performance were evaluated during the night in 12 healthy elderly participants after bedtime administration of suvorexant 30 mg (a supratherapeutic dose), the GABAergic agonist zolpidem 5 mg (the recommended dose in the elderly), or placebo. Balance (body sway measured by platform stability) and psychomotor performance (measured by choice reaction time) were assessed predose and at 1.5, 4, and 8 hours postdose in each period. Memory (measured by word recall) was assessed predose and at 4 hours postdose. FINDINGS/RESULTS: At 1.5 hours after nighttime administration of each drug (the approximate time of their anticipated maximal plasma concentrations), both zolpidem and suvorexant increased body sway versus placebo, with a greater increase for zolpidem than suvorexant. Suvorexant increased choice reaction time compared with placebo or zolpidem at 1.5 hours. There were no treatment differences on body sway or choice reaction time at 4 or 8 hours, or on word recall at 4 hours. IMPLICATIONS/CONCLUSIONS: These exploratory data suggest that a 30-mg dose of suvorexant (supratherapeutic) and a 5-mg dose of zolpidem (recommended dose in the elderly) impaired balance at 1.5 hours in healthy elderly people, with potentially less impairment for suvorexant relative to zolpidem, but no treatment differences on body sway or psychomotor performance at 4 and 8 hours. Because of their exploratory nature, these findings and their clinical relevance, if any, require confirmation in a prospective study.


Subject(s)
Azepines , Memory/drug effects , Postural Balance/drug effects , Psychomotor Performance/drug effects , Triazoles , Zolpidem , Aged , Azepines/administration & dosage , Azepines/adverse effects , Cross-Over Studies , Double-Blind Method , Drug Chronotherapy , Drug Monitoring/methods , Female , GABA-A Receptor Agonists/administration & dosage , GABA-A Receptor Agonists/adverse effects , Healthy Volunteers , Humans , Male , Neuropsychological Tests , Orexin Receptor Antagonists/administration & dosage , Orexin Receptor Antagonists/adverse effects , Reaction Time/drug effects , Sleep Aids, Pharmaceutical/administration & dosage , Sleep Aids, Pharmaceutical/adverse effects , Triazoles/administration & dosage , Triazoles/adverse effects , Zolpidem/administration & dosage , Zolpidem/adverse effects
6.
Pharmacol Res Perspect ; 9(2): e00758, 2021 04.
Article in English | MEDLINE | ID: mdl-33822479

ABSTRACT

Lemborexant, a dual orexin receptor antagonist, is approved in the United States, Japan, and Canada for the treatment of insomnia in adults. This phase I, multicenter, open-label, parallel-group study assessed the impact of mild or moderate hepatic impairment (HI) on lemborexant pharmacokinetics and metabolism. The pharmacokinetics, tolerability, and safety of lemborexant were evaluated in subjects with mild (Child-Pugh class A) or moderate (Child-Pugh class B) HI and healthy age-, sex-, and body mass index (BMI)-matched control subjects (n = 8 subjects/group). Subjects received a single oral dose of lemborexant 10 mg (LEM10). Blood samples were collected up to 312 hours post dosing for lemborexant pharmacokinetics assessments. Median time to maximum plasma concentration was similar across all groups. Compared with healthy subjects, exposure measures (maximum plasma concentration [Cmax ] and area under the curve extrapolated to infinity [AUC0-inf ]) increased by ~58% (Cmax ) and ~25% (AUC0-inf ) in subjects with mild HI and ~22% (Cmax ) and ~54% (AUC0-inf ) in subjects with moderate HI. Clearance decreased by 20% and 35% in subjects with mild and moderate HI, respectively, versus healthy subjects. Lemborexant unbound fraction was similar in all groups (range: 0.060-0.065). All treatment-emergent adverse events (TEAEs) were mild in severity; no serious TEAEs occurred. In conclusion, following a single LEM10 dose, lemborexant exposure was similar in subjects with mild HI and increased in subjects with moderate HI versus healthy subjects. No dose adjustment is required in subjects with mild HI. Dosing in subjects with moderate HI should be restricted to 5 mg. Lemborexant was well tolerated in all groups.


Subject(s)
Hepatic Insufficiency/metabolism , Hepatobiliary Elimination/physiology , Pyridines/pharmacokinetics , Pyrimidines/pharmacokinetics , Sleep Aids, Pharmaceutical/pharmacokinetics , Administration, Oral , Adolescent , Adult , Aged , Area Under Curve , Female , Healthy Volunteers , Hepatic Insufficiency/diagnosis , Hepatic Insufficiency/physiopathology , Humans , Male , Middle Aged , Pyridines/administration & dosage , Pyridines/adverse effects , Pyrimidines/administration & dosage , Pyrimidines/adverse effects , Severity of Illness Index , Sleep Aids, Pharmaceutical/administration & dosage , Sleep Aids, Pharmaceutical/adverse effects , Sleep Initiation and Maintenance Disorders/drug therapy , Young Adult
7.
Biomed Pharmacother ; 133: 110955, 2021 Jan.
Article in English | MEDLINE | ID: mdl-33190032

ABSTRACT

BACKGROUND/AIMS: The aim of this single-center, double-blind study was to investigate the effect of a 4-week once daily administration of 200 mg almorexant on tear film break-up time, spermatogenesis, hormone levels, and pancreatic elastase in stool in healthy male subjects. METHODS: Almorexant 200 mg or matching placebo was administered in the evening for 4 weeks once daily to 56 healthy male subjects. Changes in ophthalmological variables, sperm composition, hormone levels, and pancreatic elastase levels in stool were evaluated periodically up to 8 weeks after discontinuation of drug administration. Blood samples for pharmacokinetic measurements were taken after 4 weeks to confirm compliance to study drug intake. RESULTS: The results of this study revealed no treatment effects of almorexant, neither on tear film break-up time nor on other ophthalmological variables investigated during this study. Furthermore, spermatogenesis, hormones of the hypothalamic-pituitary-adrenal and -gonadal axes, and endocrine pancreatic secretion were shown to be not affected by a 4-week once daily administration of almorexant. CONCLUSION: Almorexant was well tolerated and had no effect on the spectrum of pharmacodynamic variables assessed. Ophthalmology and testicular findings detected in preclinical studies were not observed in this clinical study. Therefore, these preclinical findings appear not to be relevant for humans and do not prevent from conducting larger clinical trials with either healthy subjects or patients.


Subject(s)
Acetamides/administration & dosage , Hormones/blood , Isoquinolines/administration & dosage , Lacrimal Apparatus/drug effects , Orexin Receptor Antagonists/administration & dosage , Sleep Aids, Pharmaceutical/administration & dosage , Spermatogenesis/drug effects , Acetamides/adverse effects , Acetamides/blood , Acetamides/pharmacokinetics , Administration, Oral , Adult , Biomarkers/blood , Double-Blind Method , Drug Administration Schedule , Healthy Volunteers , Humans , Isoquinolines/adverse effects , Isoquinolines/blood , Isoquinolines/pharmacokinetics , Lacrimal Apparatus/physiology , Male , Orexin Receptor Antagonists/adverse effects , Orexin Receptor Antagonists/blood , Orexin Receptor Antagonists/pharmacokinetics , Patient Safety , Prospective Studies , Risk Assessment , Sleep Aids, Pharmaceutical/adverse effects , Sleep Aids, Pharmaceutical/blood , Sleep Aids, Pharmaceutical/pharmacokinetics , South Africa , Tears , Time Factors , Young Adult
8.
Clin J Am Soc Nephrol ; 16(1): 88-97, 2020 12 31.
Article in English | MEDLINE | ID: mdl-33355192

ABSTRACT

BACKGROUND AND OBJECTIVES: Zolpidem, a nonbenzodiazepine hypnotic, and trazodone, a sedating antidepressant, are the most common medications used to treat insomnia in the United States. Both drugs have side effect profiles (e.g., drowsiness, dizziness, and cognitive and motor impairment) that can heighten the risk of falls and fractures. Despite widespread zolpidem and trazodone use, little is known about the comparative safety of these medications in patients receiving hemodialysis, a vulnerable population with an exceedingly high fracture rate. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Using data from the United States Renal Data System registry (2013-2016), we conducted a retrospective cohort study to investigate the association between the initiation of zolpidem versus trazodone therapy and the 30-day risk of hospitalized fall-related fractures among Medicare-enrolled patients receiving maintenance hemodialysis. We used an active comparator new-user design and estimated 30-day inverse probability of treatment-weighted hazard ratios and risk differences. We treated death as a competing event. RESULTS: A total of 31,055 patients were included: 18,941 zolpidem initiators (61%) and 12,114 trazodone initiators (39%). During the 30-day follow-up period, 101 fall-related fractures occurred. Zolpidem versus trazodone initiation was associated with a higher risk of hospitalized fall-related fracture (weighted hazard ratio, 1.71; 95% confidence interval, 1.11 to 2.63; weighted risk difference, 0.17%; 95% confidence interval, 0.07% to 0.29%). This association was more pronounced among individuals prescribed higher zolpidem doses (hazard ratio, 1.85; 95% confidence interval, 1.10 to 3.01; and risk difference, 0.20%; 95% confidence interval, 0.04% to 0.38% for higher-dose zolpidem versus trazodone; and hazard ratio, 1.60; 95% confidence interval, 1.01 to 2.55 and risk difference, 0.14%; 95% confidence interval, 0.03% to 0.27% for lower-dose zolpidem versus trazodone). Sensitivity analyses using longer follow-up durations yielded similar results. CONCLUSIONS: Among individuals receiving maintenance hemodialysis, zolpidem initiators had a higher risk of hospitalized fall-related fracture compared with trazodone initiators. PODCAST: This article contains a podcast at https://www.asn-online.org/media/podcast/CJASN/2020_12_18_CJN10070620_final.mp3.


Subject(s)
Fractures, Bone/epidemiology , Renal Insufficiency, Chronic/therapy , Sleep Aids, Pharmaceutical/adverse effects , Trazodone/adverse effects , Zolpidem/adverse effects , Accidental Falls/statistics & numerical data , Aged , Cognitive Dysfunction/chemically induced , Dizziness/chemically induced , Drug Prescriptions/statistics & numerical data , Female , Hospitalization/statistics & numerical data , Humans , Male , Medicare/statistics & numerical data , Middle Aged , Registries , Renal Dialysis , Retrospective Studies , Sleep Aids, Pharmaceutical/administration & dosage , Sleep Initiation and Maintenance Disorders/drug therapy , United States/epidemiology , Zolpidem/administration & dosage
9.
AAPS PharmSciTech ; 22(1): 9, 2020 Nov 25.
Article in English | MEDLINE | ID: mdl-33241538

ABSTRACT

Death from an accidental or intentional overdose of sleeping tablets has increased exponentially in the USA. Furthermore, the simultaneous consumption of sleeping tablets with alcoholic beverages not only intensifies the effect of sleeping tablets but also leads to blackouts, sleepwalking, and death in many cases. In this article, we proposed a unique and innovative technology to prevent multi-tablet and alcohol-associated abuse of sleeping tablet. Agonist- and antagonist-loaded polymeric filaments of appropriate Eudragit® polymers were prepared using hot melt extrusion. Metoprolol tartrate and hydrochlorothiazide were used as model drugs in place of zolpidem tartrate (agonist-BCS class I) and flumazenil (antagonist-BCS class IV), respectively. Crushed filaments were converted into a tablet with a novel rapidly soluble co-processed alkalizing agent. Dissolution studies of single tablet and multiple tablets (5) in fasted state simulated gastric fluid (FaSSGF) confirmed that the release of the agonist was significantly (p < 0.0001) reduced in multi-tablet dissolution. Furthermore, the release of antagonist was significantly higher when tablet was exposed to FaSSGF+20% ethanol and various alcoholic beverages. Thus, appropriate use of Eudragit® polymer's chemistry could help design a tablet to prevent the release of agonist in case of overdose and simultaneous release of antagonist when consumed with alcohol.


Subject(s)
Drug Overdose , Ethanol/administration & dosage , Humans , Polymers/chemistry , Polymethacrylic Acids , Sleep Aids, Pharmaceutical/administration & dosage , Solubility , Tablets
10.
Neuropsychopharmacol Rep ; 40(4): 383-387, 2020 12.
Article in English | MEDLINE | ID: mdl-32990413

ABSTRACT

INTRODUCTION: Non-24-hour sleep-wake disorder (N24SWD) is often observed in the visually impaired and those who isolate indoors. Melatonin receptor agonists may be used for treatment, but there is currently no evidence that they are effective in patients without visual impairment. CASE: We report a case of a 23-year-old woman who withdrew from her social life owing to autism spectrum disorder and experienced an unusual sleep rhythm. She presented with N24SWD. The N24SWD cycle averaged 25.6 days but was extended to 42 days using ramelteon. However, this was not enough. We prescribed the addition of suvorexant and the sleep cycle returned to normal. CONCLUSION: N24SWD is a disease that seriously impairs social life and productivity. We propose a possible treatment strategy for N24SWD using ramelteon and suvorexant.


Subject(s)
Autism Spectrum Disorder/drug therapy , Azepines/administration & dosage , Indenes/administration & dosage , Sleep Aids, Pharmaceutical/administration & dosage , Sleep Disorders, Circadian Rhythm/drug therapy , Triazoles/administration & dosage , Autism Spectrum Disorder/complications , Autism Spectrum Disorder/diagnosis , Drug Therapy, Combination , Female , Humans , Sleep Disorders, Circadian Rhythm/complications , Sleep Disorders, Circadian Rhythm/diagnosis , Treatment Outcome , Young Adult
11.
Expert Opin Drug Metab Toxicol ; 16(11): 1063-1078, 2020 Nov.
Article in English | MEDLINE | ID: mdl-32901578

ABSTRACT

INTRODUCTION: The last two decades have witnessed a rapid increase in the knowledge about the role of the orexin system, particularly in the regulation of wakefulness and arousal. Dual orexin receptor antagonists (DORAs) have been approved for the treatment of insomnia disorders (suvorexant, lemborexant) and drugs with a distinctive profile (daridorexant) or orexin-2 receptor selectivity (seltorexant) are in development. AREAS COVERED: This review discusses pharmacokinetics (PK), pharmacodynamics (PD), efficacy, and safety properties of orexin receptor antagonists (ORAs). EXPERT OPINION: In general, the drugs described have a similar effect on sleep characteristics although their pharmacokinetic variables differ. ORAs have the potential to revolutionize the pharmacological treatment of insomnia because they not only improve sleep, but, in addition, appear to have no dependence - and tolerance-inducing effects, which makes them suitable for long-term-treatment. The safety and tolerability profile of ORAs clearly differ from those of more traditional sleep-promoting drugs. Further research is needed to demonstrate benefits to patients suffering from insomnia disorder, e.g., with respect to improving not only sleep but also daytime functioning. In addition, ongoing and future research will show whether ORAs may have beneficial effects in patients with various psychiatric and neurodegenerative disorders, including Alzheimer's disease.


Subject(s)
Orexin Receptor Antagonists/administration & dosage , Sleep Initiation and Maintenance Disorders/drug therapy , Animals , Humans , Orexin Receptor Antagonists/adverse effects , Orexin Receptor Antagonists/pharmacology , Orexins/metabolism , Sleep Aids, Pharmaceutical/administration & dosage , Sleep Aids, Pharmaceutical/adverse effects , Sleep Aids, Pharmaceutical/pharmacology , Sleep Initiation and Maintenance Disorders/physiopathology
13.
Auris Nasus Larynx ; 47(5): 828-836, 2020 Oct.
Article in English | MEDLINE | ID: mdl-32248986

ABSTRACT

OBJECTIVES: The aims of this study are to examine the changes of tongue thickness and distance of two lingual arteries through drug-induced sleep ultrasound, and explore the relationship between sonographic measurements and clinical data. MATERIALS AND METHODS: A total of 26 confirmed obstructive sleep apnea patients were recruited in this one-year study. All patients received ultrasound examination twice (wakefulness and drug-induced sleep) in sleep center under level 1 polysomnographic monitor. Drug-induced sleep was performed by administration of one Stilnox (Zolpidem, 2 mg/tablet) and ultrasound procedure commenced once stage 2 sleep shown in polysomnography. Ultrasound imaging was implemented via submental approach with transducer position at the sagittal midline of the submental area (sagittal view) to measure thickness of the tongue. Transducer was then moved at a transverse midpoint between the inferior border of the mandible and the hyoid bone (transverse view) to measure the distance between 2 lingual arteries. RESULTS: The distance between 2 lingual arteries elongated significantly (p < .001) and thickness of tongue muscle became thinner during drug-induced sleep. The distance between 2 lingual arteries (sleep) had positive correlation with apnea/hypopnea index (AHI, r = 0.51, p = .008) and body mass index (BMI, r = 0.46, p = .018). CONCLUSION: Drug-induced sleep ultrasound is feasible to measure changes of tongue in OSA patients. Ultrasound imaging showed that tongue muscle became thinner in conjunction with significant widening in distance between two lingual arteries during hypnotic-induced sleep and that was positively correlated with AHI and BMI. Drug-induced sleep ultrasound may be helpful to enhance safety in tongue surgery for OSA patients.


Subject(s)
Sleep Aids, Pharmaceutical/administration & dosage , Sleep Apnea, Obstructive/diagnostic imaging , Tongue/diagnostic imaging , Ultrasonography , Zolpidem/administration & dosage , Adult , Body Mass Index , Female , Humans , Male , Middle Aged , Mouth/anatomy & histology , Polysomnography , Regression Analysis , Severity of Illness Index , Sleep/drug effects , Tongue/anatomy & histology
14.
Braz. J. Psychiatry (São Paulo, 1999, Impr.) ; 42(2): 175-184, Mar.-Apr. 2020. tab, graf
Article in English | LILACS | ID: biblio-1089249

ABSTRACT

Objective: To evaluate the safety and efficacy of a 5 mg sublingual dose of zolpidem, compared to a 10 mg oral dose, at bedtime and "as needed" following middle-of-the-night awakenings. Methods: Participants were randomized into an oral group (oral zolpidem 10 mg and sublingual placebo at bedtime and "as-needed") and a sublingual group (oral placebo and sublingual zolpidem 5 mg at bedtime and "as-needed"). Participants underwent medical evaluation, polysomnography, the psychomotor vigilance test, and completed questionnaires. Results: Of 85 patients, 67 met the criteria for insomnia (48±10 years; 79% women) and were randomized. Of these, 46 completed 92±5 days of treatment. Mild-to-moderate adverse events were reported by 25% of the participants, including headache, sleepiness, and dizziness. Both treatments decreased middle-of-the-night awakenings by an average of -3.1±2.3 days/week and increased total sleep time by 1.5 hours. Changes in sleep quality and insomnia severity scores were also favorable and comparable between groups: variation depended on continuation of treatment. Regarding PSG findings, sleep latency decreased more in the sublingual group than the oral group (-14±42 vs. 10±29 min; p = 0.03). The psychomotor vigilance test showed minor residual effects 30 minutes after awakening, which reversed after 2 hours. Conclusions: The safety and efficacy of both zolpidem formulations are comparable. The sublingual 5 mg dose induced sleep more rapidly. Clinical trial registration: NCT01896336


Subject(s)
Humans , Male , Female , Adult , Sleep Aids, Pharmaceutical/administration & dosage , Sleep Initiation and Maintenance Disorders/drug therapy , Administration, Sublingual , Double-Blind Method , Administration, Oral , Prospective Studies , Treatment Outcome , Polysomnography , Zolpidem/administration & dosage , Middle Aged
15.
BMJ Open ; 10(2): e033688, 2020 02 18.
Article in English | MEDLINE | ID: mdl-32075832

ABSTRACT

INTRODUCTION: Problematic benzodiazepine use is a global health issue. Although the adverse side effects of long-term use of benzodiazepines are well known, it remains difficult to implement interventions for discontinuation in primary care. Considering the success of blended care for the treatment of sleeping disorders and the support of substance use disorders, evidence suggests that a blended care approach, combining face-to-face consultations with the general practitioner with web-based self-learning by the patient, is beneficial for the discontinuation of chronic benzodiazepine use for primary insomnia in general practice. Therefore, the aim of this study is to evaluate the effectiveness of such an approach for the discontinuation of benzodiazepine and zolpidem, zopiclone and zaleplon drugs ((z-)BZD) use in the long term and evaluate the implementation process. METHODS AND ANALYSIS: This study is a multicentre, pragmatic, cluster randomised controlled trial with 1200 patients, included by 120 general practitioners. Allocation to usual or blended care happens at the level of the general practice in a 1:1 ratio using a block randomisation system stratified per language. The study population consists of adult primary care patients who have been using (z-)BZD for primary insomnia on a daily basis for at least 6 months. Primary outcome measure is the proportion of patients that discontinued (z-)BZD at 12 months assessed by toxicological screening for (z-)BZD in urine. Secondary outcomes include discontinuation of (z-)BZD at 6 months, quality of life and the number of defined daily doses of (z-)BZD prescribed. Data will be collected using a study-specific online platform and analysed using the intention-to-treat approach. The process of implementing blended care will be evaluated in a nested study. ETHICS AND DISSEMINATION: This trial was approved by the Ethics Committee for Research of UZ/KU Leuven (ref. S61194). Study results will be disseminated via open-access, peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: NCT03937180.


Subject(s)
Behavior Therapy , Benzodiazepines , Patient Education as Topic , Primary Health Care , Sleep Aids, Pharmaceutical , Sleep Initiation and Maintenance Disorders/therapy , Adolescent , Adult , Aged , Benzodiazepines/administration & dosage , Benzodiazepines/adverse effects , Benzodiazepines/therapeutic use , Female , General Practice , General Practitioners , Humans , Male , Middle Aged , Randomized Controlled Trials as Topic , Research Design , Sleep Aids, Pharmaceutical/administration & dosage , Sleep Aids, Pharmaceutical/adverse effects , Sleep Aids, Pharmaceutical/therapeutic use , Sleep Initiation and Maintenance Disorders/drug therapy , Substance-Related Disorders/etiology , Treatment Outcome , Young Adult
16.
J Child Adolesc Psychopharmacol ; 30(5): 335-341, 2020 06.
Article in English | MEDLINE | ID: mdl-31976753

ABSTRACT

Objectives: To investigate the use of sleep medication and concomitant psychotropic medication in children and adolescents placed under residential care (RC). Methods: Participants were youth 0-20 years of age placed in RC institutions at least once during 2016. Data on filled prescriptions were taken from the Norwegian Prescription Database to compare the use of sleep medication in RC with the general child population (GenPop) and how it covaried with gender, age, reasons for RC placement, and concomitant use of other psychotropic medications (antidepressants, anxiolytics, antipsychotics, and psychostimulants). Results: A total of 2171 youths were identified in RC at mean age 14 years (82% ≥ 13 years). Seventeen percent (371/2171) used sleep medications (melatonin 11%, alimemazine 7%, and benzodiazepines/z-hypnotics 2%) significantly more than the 2.3% who used in GenPop. The girl/boy ratio for medication use in RC was 1.8 (95% confidence interval [CI] = 1.5-2.2), not significantly different from the corresponding ratio in GenPop (1.4; 95% CI = 1.3-1.5). The use of sleep medication increased with age. When comparing reasons for placement in RC, medication use was particularly low among unaccompanied minor asylum seekers (2%). About half of the youths used concomitant psychotropic medication, with clear gender differences; girls used about twice as much antidepressants, anxiolytics, and antipsychotics, whereas boys used 1.3 times more psychostimulants. Conclusion: Youths in RC used more sleep medication and concomitant psychotropic medication than the GenPop, most likely reflecting the increased psychosocial strain and mental disorders reported in this population. Further studies of prevalence, assessment, and treatment of sleep problems in RC populations are warranted.


Subject(s)
Mental Disorders/drug therapy , Psychotropic Drugs/administration & dosage , Sleep Aids, Pharmaceutical/administration & dosage , Sleep Wake Disorders/drug therapy , Adolescent , Age Factors , Child , Child, Preschool , Databases, Factual , Female , Humans , Infant , Male , Norway , Residential Facilities , Sex Factors , Young Adult
17.
Alzheimers Dement ; 16(3): 541-551, 2020 03.
Article in English | MEDLINE | ID: mdl-31944580

ABSTRACT

INTRODUCTION: We evaluated the clinical profile of the orexin receptor antagonist suvorexant for treating insomnia in patients with mild-to-moderate probable Alzheimer's disease (AD) dementia. METHODS: Randomized, double-blind, 4-week trial of suvorexant 10 mg (could be increased to 20 mg based on clinical response) or placebo in patients who met clinical diagnostic criteria for both probable AD dementia and insomnia. Sleep was assessed by overnight polysomnography in a sleep laboratory. The primary endpoint was change-from-baseline in polysomnography-derived total sleep time (TST) at week 4. RESULTS: Of 285 participants randomized (suvorexant, N = 142; placebo, N = 143), 277 (97%) completed the trial (suvorexant, N = 136; placebo, N = 141). At week 4, the model-based least squares mean improvement-from-baseline in TST was 73 minutes for suvorexant and 45 minutes for placebo; (difference = 28 minutes [95% confidence interval 11-45], p < 0.01). Somnolence was reported in 4.2% of suvorexant-treated patients and 1.4% of placebo-treated patients. DISCUSSION: Suvorexant improved TST in patients with probable AD dementia and insomnia.


Subject(s)
Alzheimer Disease/psychology , Azepines/administration & dosage , Polysomnography , Sleep Aids, Pharmaceutical/administration & dosage , Sleep Initiation and Maintenance Disorders/drug therapy , Sleep/drug effects , Triazoles/administration & dosage , Aged , Female , Humans , Male
18.
Geriatr Nurs ; 41(4): 400-405, 2020.
Article in English | MEDLINE | ID: mdl-31899005

ABSTRACT

The purpose of this study was to examine the impact of prescription sleep medications on physical activity (PA) participation among diabetic older adults. We analyzed cross-sectional data of 1,581 respondents ≥ 50 years from the 2006-2014 waves of the Health and Retirement Study. The respondents self-reported frequency of their PA from light, moderate and vigorous activity and whether they regularly took prescription sleep medications. We found that 381 of 1,581 respondents (24%) reported regular use of prescription medications for sleep. Hierarchical linear regression models revealed that use of prescription sleep medications significantly predicted less participation in PA after controlling for demographic variables, personality traits, social support, environmental factors, social integration, sensory functions, presence of pain, prescription pain medication use, body mass index, and health conditions. The finding highlights that use of prescription sleep medications may be an important risk factor of physical inactivity in diabetic older adults.


Subject(s)
Diabetes Mellitus/psychology , Exercise/physiology , Sleep Aids, Pharmaceutical/administration & dosage , Aged , Cross-Sectional Studies , Female , Health Surveys , Humans , Male , Risk Factors , Sleep/drug effects
19.
Clin J Sport Med ; 30(6): 544-549, 2020 11.
Article in English | MEDLINE | ID: mdl-29933284

ABSTRACT

OBJECTIVE: Prescription opioid misuse has become a significant public health issue. Previous research has examined predictors of prescription opioid use and misuse among former National Football League (NFL) players. The present study aimed to describe how reasons for prescription opioid use while in the NFL corresponds to use and misuse in retirement. DESIGN: Former NFL players reporting prescription opioid use during their playing careers (N = 336) were included in this secondary data analysis. Participants reported reasons for prescription opioid use, including pain management, use "to function," to improve mood, to reduce stress, and to aid sleep. RESULTS: Among retired NFL players with exposure to prescribed pain medication during their playing career, 26.2% reported recent use of prescription opioids (past 30 days) and 73.8% reported no use. Specifically, 14.3% of retired players reported opioid use only as prescribed, whereas 11.9% reported misuse (not prescribed or use other than as prescribed). Using prescription opioids to function while in the NFL was associated with any opioid use in the past 30 days [odds ratios (OR) = 1.30, 95% CI: 1.12-1.50, P < 0.001]. Further, opioid use in the NFL to reduce stress and anxiety was associated with increased odds of past 30-day misuse of prescription opioids (OR = 1.45, 95% CI: 1.01-2.11; P = 0.048). CONCLUSIONS: The present study adds to the literature on elite athletes at high risk for pain and prescription opioid use and misuse. The findings may help to identify and provide early intervention for professional athletes most at risk for misuse of prescription opioids.


Subject(s)
Analgesics, Opioid/administration & dosage , Athletes/statistics & numerical data , Football/statistics & numerical data , Opioid-Related Disorders/epidemiology , Retirement/statistics & numerical data , Affect/drug effects , Anxiety/drug therapy , Athletes/psychology , Confidence Intervals , Humans , Logistic Models , Male , Middle Aged , Occupational Stress/drug therapy , Odds Ratio , Opioid-Related Disorders/etiology , Pain Management/methods , Risk Factors , Sleep Aids, Pharmaceutical/administration & dosage
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