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Arq. neuropsiquiatr ; 79(8): 732-742, Aug. 2021. tab, graf
Article in English | LILACS | ID: biblio-1339229


ABSTRACT Background: Insomnia is a sleep disorder characterized by difficulty of falling asleep or maintaining sleep, which affects different age groups. Currently, melatonin is used as a therapeutic treatment in cases of insomnia in children, adults, and elderly people. Objective: To evaluate the effectiveness of melatonin in sleep disorders, its dosage, potential adverse effects, as well as labeling laws and regulations in Brazil. Methods: This integrative review was carried out using the Cochrane Library, Medline (Pubmed), and Science Direct databases. Twenty-five articles and three documents available on the Brazilian Society of Endocrinology and Metabology (SBEM) and National Health Surveillance Agency (ANVISA) websites published between 2015 and 2020 were selected to be evaluated in full. Results: It was found that in most of the selected articles the use of melatonin reduces sleep latency. The effective melatonin doses varied according to each age group, from 0.5 to 3 mg in children, 3 to 5 mg in adolescents, 1 to 5 mg in adults, and 1 to 6 mg in elderly people. Side effects are mild when taking usual doses. In Brazil, no registered drug and current regulation on the use and marketing of melatonin has been identified. Conclusion: The use of melatonin is an alternative therapy that can be used for sleeping disorders. According to the evidences found, it did not demonstrate toxicity or severe side effects, nor dependence even when administered at high doses, suggesting that it is a safe medication to treat patients of different ages suffering from sleeping disorders.

RESUMO Antecedentes: Insônia é um distúrbio do sono caracterizado por dificuldade de iniciar e manter o sono, afetando diferentes faixas etárias. Atualmente, a melatonina é utilizada no tratamento de insônia em crianças, adultos e idosos. Objetivo: Avaliar a eficácia da melatonina nos distúrbios do sono, posologia e potenciais efeitos adversos, bem como a regulamentação vigente no Brasil. Métodos: Trata-se de uma revisão integrativa, os artigos foram identificados nas bases de dados Cochrane Library, Medline (Pubmed) e Science Direct, totalizando 25 artigos, e foram selecionados três materiais disponíveis no site da Sociedade Brasileira de Endocrinologia e Metabologia e Agência Nacional de Vigilância Sanitária, publicados entre 2015 e 2020. Resultados: Verificou-se na maioria dos artigos selecionados que a melatonina reduz a latência do sono. Quanto as dosagens de melatonina identificou-se variação em cada faixa etária, para crianças de 0,5 a 3mg; adolescentes de 3 a 5mg; adultos de 1 a 5mg e idosos 1 mg a 6 mg demostraram serem eficazes. Em doses habituais os efeitos colaterais são leves. No Brasil, não foi identificado medicamento registrado e regulamentação vigente sobre o uso e comercialização de melatonina. Conclusão: A utilização da melatonina é uma alternativa que pode ser utilizada em distúrbios do sono. De acordo com as evidências encontradas, não demonstrou toxicidade ou efeitos colaterais severos, nem dependência mesmo em doses elevadas, sendo, portanto, segura para tratamento de pacientes desde crianças a idosos que sofrem de distúrbios do sono.

Humans , Child , Adolescent , Adult , Aged , Sleep Wake Disorders/drug therapy , Sleep Initiation and Maintenance Disorders/drug therapy , Melatonin/therapeutic use , Sleep , Brazil
Article in Chinese | WPRIM | ID: wpr-879113


Based on the research literatures of Passiflora incarnata and the theory of traditional Chinese medicine, the paper discussed the traditional Chinese medicinal properties of P. incarnate, so as to provide a theoretical basis for the compatibility and application of P. incarnata. The literature databases of CNKI, Wanfang, VIP, Web of Science, PubMed and Scopus were selected, and the literatures relating to P. incarnata were reviewed to screen out the scientific research literatures with a high credibility, rational design and reliable conclusions. Foreign pharmacopoeia was consulted, and the listed products were summarized. The traditional Chinese medicine properties of P. incarnata were studied based on 32 clinical trials, 66 pharmacological researches, 64 chemical constituents researches as well as the theory of traditional Chinese medicine. It was preliminarily concluded that the medicinal properties of P. incarnata are sweet, cool, and enter heart, liver channels. The function is mainly to calm the heart and tranquilizing the mind, and calm the liver wind. It is used for hyperactivity of liver-Yang, stagnation of liver-Qi, restlessness of mind, depression, nervousness, insomnia. This paper summarized the source, characteristics of natures, tastes and channel tropism, usage and dosage, function indications of P. incarnata, and defined its clear traditional Chinese medicine property, which lays a theoretical foundation for the compatibility and clinical application of P. incarnata and Chinese medicine.

Anti-Anxiety Agents , Anxiety , Drugs, Chinese Herbal , Humans , Medicine, Chinese Traditional , Passiflora , Sleep Initiation and Maintenance Disorders/drug therapy
Article in Chinese | WPRIM | ID: wpr-888156


To systematically evaluate the efficacy of oral Chinese patent medicines of Ziziphi Spinosae Semen in the treatment of primary insomnia by using network Meta-analysis. Nine databases(CNKI, Wanfang, VIP, CBM, PubMed, EMbase, Web of Science, Medline and Cochrane Library) were systematically and comprehensively undertaken to identify the literatures published from the establishment of each database to August, 2020. Randomized controlled trials(RCTs) on oral Chinese patent medicine of Ziziphi Spinosae Semen in the treatment of primary insomnia, either alone or in combination with conventional sedative hypnotics, were screened out according to inclusion criteria and exclusion criteria. Literature screening, data extraction and the evaluation of the risk of bias for the included studies were conducted independently by 2 researchers. Traditional Meta-analysis and Bayesian network Meta-analysis were then conducted with use of Stata 15.0 and R software. Finally, a total of 42 RCTs were included, involving 9 kinds of oral Chinese patent medicines and 4 196 patients. The results of Meta-analysis showed that(1) in terms of improving Pittsburgh sleep quality index scale score, the efficacy of the combination of drugs was significantly superior to that of sedative-hypnotics or most of Chinese patent medicines used alone, and Bailemian Capsules combined with sedative-hypnotics had the best effect; both the efficacy of Shenqi Wuweizi Tablets and Compound Zaoren Anshen Capsules alone were significantly superior to that of conventional sedative-hypnotics treatment, and Shenqi Wuweizi Tablets had the best effect.(2)In terms of safety, single use or combined use of Chinese patent medicine had a certain improvement as compared with conventional sedative-hypnotics treatment. Due to the large clinical heterogeneity, the studies could not be combined quantitatively, and no serious adverse reactions occurred in all patients enrolled in the study. The results showed that Chinese patent medicine of Ziziphi Spinosae Semen combined with conventional sedative-hypnotics could significantly improve the short-term sleep quality of patients with primary insomnia. In the comparison among single use of drugs, Shenqi Wuweizi Tablets had the largest possibility for best effect. However, the lack of evidences for international promotion, the influence of different types of sedative-hypnotics treatment and intervention time on the curative effect, and the patients' different acceptance of combined treatment should be considered before clinical application. Limited by the number and quality of the included studies, the above conclusions need to be further verified by more large sample-size and high-quality studies.

Bayes Theorem , China , Drugs, Chinese Herbal/therapeutic use , Humans , Network Meta-Analysis , Nonprescription Drugs , Semen , Sleep Initiation and Maintenance Disorders/drug therapy
Article in Chinese | WPRIM | ID: wpr-921687


To evaluate the efficacy and safety of Chinese patent medicines in the treatment of insomnia by frequency network Meta-analysis. Randomized controlled trials of Chinese patent medicines for insomnia were retrieved from CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase and Cochrane Library databases from the time of database establishment to October 2020. The quality of the included RCTs was evaluated according to the Cochrane bias risk standard, and the data was analyzed by RevMan 5.3 and Stata/MP 15.1. A total of 11 kinds of Chinese patent medicines in 27 RCTs were included. According to Meta-analysis, in term of the effective rate, Tianmeng Liquid, Zaoren Anshen Capsules, Shumian Capsules, Shensong Yangxin Capsules, Shenqi Wuweizi Tablets, Shugan Jieyu Capsules, Anshen Bunao Liquid and Qiye Anshen Tablets combined with nonbenzodiazepine drugs(NBZDs) were superior to NBZDs alone. In term of the improvement of Pittsburg sleeping quality index(PSQI) score, Tianmeng Liquid, Shumian Capsules, Shensong Yangxin Capsules, Bailemian Capsules, Shenqi Wuweizi Tablets, Shugan Jieyu Capsules, Yangxue Qingnao Granules and Yindan Xinnaotong Capsules combined with NBZDs were superior to NBZDs alone. In terms of the safety, Shumian Capsules, Shensong Yangxin Capsules, Shenqi Wuweizi Tablets and Qiye Anshen Tablets combined with NBZDs were superior to NBZDs alone. In terms of the avoidance of dizziness and headache, Qiye Anshen Tablets combined with NBZDs were superior to NBZDs alone. The results of Network Meta-analysis indicated that in term of the effective rate, top three optimal medication regimens were NBZDs combined with Shugan Jieyu Capsules, combined with Zaoren Anshen Capsules and combined with Shensong Yangxin Capsules in the order from high to low. With the respect of improvement of PSQI score, top three optimal medication regimens were NBZDs combined with Yangxue Qingnao Granules, combined with Tianmeng Liquid and combined with Yindan Xinnaotong Capsules in the order from high to low. In terms of the safety, top three optimal medication regimens were NBZDs combined with Qiye Anshen Tablets, combined with Shensong Yangxin Capsules and combined with Shenqi Wuweizi Tablets in the order from high to low. In terms of the avoidance of dizziness and headache, top three optimal medication regimens were NBZDs combined with Qiye Anshen Tablets, combined with Zaoren Anshen Capsules and combined with Shumian Capsules in the order from high to low. In terms of the avoidance of fatigue, top three optimal medication regimens were NBZDs combined with Shensong Yangxin Capsules, combined with Shumian Capsules and combined with Qiye Anshen Tablets in the order from high to low. In conclusion, Chinese patent medicines combined with NBZDs can effectively alleviate the symptoms of insomnia with a high safety. However, the conclusion of this study needs to be verified by more high-quality studies because of the low methodological quality of the included studies.

China , Drugs, Chinese Herbal , Humans , Medicine, East Asian Traditional , Network Meta-Analysis , Nonprescription Drugs , Sleep Initiation and Maintenance Disorders/drug therapy
Article in Chinese | WPRIM | ID: wpr-888027


Huanglian Ejiao Decoction,firstly recorded in Treatise on Febrile Diseases,could be used to treat heat-conversion syndrome of Shaoyin. It has been identified that,the indications of Huanglian Ejiao Decoction include:(1)in modern medicine,it can be used to treat insomnia,arrhythmia,oral ulcer,Xiali,blood syndrome and other diseases;(2)in terms of symptoms and signs,it is mainly used for restlessness,ritability,insomnia,extremely difficult to fall asleep,palpitation,atrial premature beat,ventricular premature beat and other arrhythmias,stomach distension and stuffiness,stomach pain,vomiting,abdominal pain,cramps,lower edge,constipation,blush,red lips,easy bleeding,red tongue,thin or no coating,dry tongue surface,or light red tongue,or dark red,thin white tongue coating,and rapid pulse. It has been also identified that,(1)although the original statement of Huanglian Ejiao Decoction is very simple,it can not only be used according to irritability and insomnia;(2)tongue image is not the key to syndrome differentiation of this prescription;(3)the essence of Shaoyin syndrome is not completely heart kidney Yang deficiency,which is closest to shock in modern medicine,including septic shock,hypovolemic shock and cardiogenic shock;(4)the essential difference between Shaoyin cold and heat conversion syndrome of Shaoyin lies in the different types of shock,in which cardiogenic shock is the main cold type,while septic shock is the main heat shock;(5)heat-conversion syndrome of Shaoyin is more common in the late stage of septic shock,and part of it can be seen in the stage of heart failure combined with sympathetic activation;(6)Dioscoreae Rhizoma and Rehmanniae Radix are often used to replace egg yolk;(7)Huanglian Ejiao Decoction takes effect quickly and the course of treatment is short.

Drugs, Chinese Herbal/therapeutic use , Gelatin , Humans , Medicine, Chinese Traditional , Sleep Initiation and Maintenance Disorders/drug therapy , Yang Deficiency
Rev. medica electron ; 41(2): 483-495, mar.-abr. 2019.
Article in Spanish | LILACS, CUMED | ID: biblio-1004283


RESUMEN El insomnio es el trastorno del sueño más frecuente en la población, se acompaña de un nivel significativo de malestar o deterioro de áreas importantes del funcionamiento humano. Es importante realizar un diagnóstico correcto de este desorden con el objetivo de instaurar un tratamiento adecuado que permita mejorar la calidad de vida de los pacientes que lo padecen. El objetivo de este artículo es ofrecer una revisión actualizada que contribuya al incremento y actualización de la información sobre este tema. Se realizó una revisión en artículos, principalmente de los últimos cinco años y se sistematizan los resultados para de esta forma contribuir a la superación de los profesionales.

ABSTRACT Insomnia is the most frequently sleep disorder in the population. It is linked to a significant discomfort and an impairment of important areas of the human functioning. The correct diagnosis of this disorder is important with the objective of prescribing an adequate treatment for improving the life quality of the patients suffering it. The aim of this article is offering an up-dated review contributing to increase and update the information on this topic. The authors carried out a review of articles published mainly during the last five years, and the results were systematized for contributing to the professionals´ upgrading.

Humans , Sleep Initiation and Maintenance Disorders/classification , Sleep Initiation and Maintenance Disorders/diagnosis , Sleep Initiation and Maintenance Disorders/psychology , Sleep Initiation and Maintenance Disorders/drug therapy , Sleep Initiation and Maintenance Disorders/therapy , Sleep Hygiene
Säo Paulo med. j ; 136(6): 579-585, Nov.-Dec. 2018. tab
Article in English | LILACS | ID: biblio-991688


ABSTRACT CONTEXT AND OBJECTIVE: Insomnia is a frequent complaint that generates more than five million visits to doctors per year in the United States. This study summarizes all Cochrane systematic reviews (SRs) that evaluated interventions to treat insomnia. DESIGN AND SETTING: Review of SRs, conducted in the Discipline of Evidence-Based Medicine, Escola Paulista de Medicina (EPM), Universidade Federal de São Paulo (UNIFESP). METHODS: A sensitive search was carried out in the Cochrane Database of Systematic Reviews to identify Cochrane SRs that assessed the effects of any type of intervention for people with insomnia. The results, main characteristics of the SRs and the certainty of the evidence obtained from them were synthesized and discussed. RESULTS: Seven SRs were included. They addressed the benefits and harm of acupuncture (n = 1), behavioral interventions (n = 1), music (n = 1), pharmacotherapy (n = 2), phototherapy (n = 1) and physical exercise (n = 1). The certainty of the evidence ranged from moderate to very low. CONCLUSION: Acupuncture, music, physical exercise, paroxetine, doxepin, trimipramine and trazodone seem to present some benefit for patients with insomnia. However, the uncertainty around these results means that no robust and definitive recommendations for clinical practice can be made until the benefits and harms from each intervention for patients with insomnia have been confirmed through further studies.

Humans , Evidence-Based Medicine , Systematic Reviews as Topic , Sleep Initiation and Maintenance Disorders/therapy , Sleep/physiology , Exercise , Acupuncture Therapy/standards , Randomized Controlled Trials as Topic , Sleep Initiation and Maintenance Disorders/drug therapy , Music Therapy/standards , Antidepressive Agents/therapeutic use
Medwave ; 18(1): e7151, 2018.
Article in English, Spanish | LILACS | ID: biblio-910365


INTRODUCCIÓN: Se ha planteado que la estimulación del sueño con cannabinoides podría constituir una alternativa terapéutica en pacientes con insomnio. MÉTODOS: Para responder esta pregunta utilizamos Epistemonikos, la mayor base de datos de revisiones sistemáticas en salud, la cual es mantenida mediante búsquedas en múltiples fuentes de información, incluyendo MEDLINE, EMBASE, Cochrane, entre otras. Extrajimos los datos desde las revisiones identificadas, reanalizamos los datos de los estudios primarios y preparamos una tabla de resumen de los resultados utilizando el método GRADE. RESULTADOS Y CONCLUSIONES: Identificamos ocho revisiones sistemáticas que en conjunto incluyen tres estudios primarios, de los cuales dos corresponden a ensayos aleatorizados. Concluimos que no está claro si los cannabinoides tienen un efecto en la severidad del insomnio o en la calidad del sueño; que podrían no tener efecto en la conciliación del sueño, despertar del sueño ni comportamiento durante vigilia, y probablemente se asocian a efectos adversos frecuentes.

INTRODUCTION: It has been suggested that cannabinoids would constitute a therapeutic alternative for patients with insomnia. METHODS: To answer this question we used Epistemonikos, the largest database of systematic reviews in health, which is maintained by screening multiple information sources, including MEDLINE, EMBASE, Cochrane, among others. We extracted data from the systematic reviews, reanalyzed data of primary studies, conducted a meta-analysis and generated a summary of findings table using the GRADE approach. RESULTS AND CONCLUSIONS: We identified eight systematic reviews including three studies overall, of which two were randomized trials. We concluded it is not clear whether cannabinoids have an effect on insomnia severity or on sleep quality; that they might have no effect on sleep conciliation, sleep awakening or behavior during wakefulness, and are probably associated with frequent adverse effects.

Humans , Cannabinoids/therapeutic use , Sleep Initiation and Maintenance Disorders/drug therapy , Randomized Controlled Trials as Topic , Databases, Factual , Treatment Outcome
Porto Alegre; Universidade Federal do Rio Grande do Sul. Telessaúde; 2018. ilus.
Non-conventional in Portuguese | LILACS | ID: biblio-995599


A insônia é o mais prevalente dos transtornos do sono. É definida como a insatisfação com a qualidade ou a quantidade de sono, que ocorre a despeito de adequada oportunidade para dormir e que impõe ao indivíduo algum tipo de prejuízo durante o dia. A prevalência da insônia crônica em sociedades industrializadas é de 5 a 10%. Entre pessoas portadoras de doença crônica (psiquiátricas ou não) e idosos, a prevalência é significativamente maior. Trata-se de queixa frequente na Atenção Primária à Saúde (APS). Este material contempla as situações mais comumente associadas a insônia na APS, assim como o manejo inicial desta queixa. Está baseado em extensa revisão das evidências disponíveis na literatura, em boas práticas clínicas e adaptado à realidade brasileira, considerando as intervenções terapêuticas disponíveis. Esta guia apresenta informação que orienta a conduta para casos de avaliação e manejo da insônia no contexto da Atenção Primária à Saúde, incluindo: Avaliação Geral, Avaliação Objetiva, Avaliação e Manejo em situações específicas, Intervenções Não-Farmacológicas, Manejo Farmacológico na APS, Retirada de benzodiazepínico, Preocupações com uso de amitriptilina, Fármacos não recomendados na APS, Avaliação longitudinal da insônia, Fluxograma para avaliação e manejo da insônia.

Humans , Sleep Initiation and Maintenance Disorders/diagnosis , Sleep Initiation and Maintenance Disorders/drug therapy , Primary Health Care , Trazodone/therapeutic use , /therapeutic use , /therapeutic use , Amitriptyline/therapeutic use , Lorazepam/therapeutic use
Rev. bras. neurol ; 53(3): 19-30, jul.-set. 2017. ilus
Article in Portuguese | LILACS | ID: biblio-876873


Esta é uma primeira parte (1/2) da abordagem de fundamentos do sono e transtornos do sono (TS) sobre aspectos: neurobiológicos (neuroanatômicos, neuroquímicos e fisiológicos); clínicos (anamnese e exame físico; exames subjetivos - questionários e escalas; exames objetivos - polissonografia, teste de latências múltiplas e actigrafia). É valorizada a terceira Classificação Internacional dos Transtornos do Sono (ICSD-3) para abordar aspectos clínicos, diagnósticos e terapêuticos, segundo as quatro queixas principais referentes dos TS: Insônia, Sonolência excessiva diurna, Movimentos e comportamentos anormais durante o sono e Incapacidade de dormir na hora desejada. Neste artigo abordamos apenas: 1-Insônia - dificuldade em adormecer ou manter-ser dormindo, acordar cedo, ou um distúrbio na qualidade do sono que faz com que o sono pareça inadequado ou não restaurador; duração: aguda ou crônica; 2- Sonolência excessiva diurna; consequente a distúrbios do sono, privação do sono; distúrbios centrais da hipersonia; distúrbios médicos ou psiquiátricos. (AU)

This is the first part (1/2) on this paper about sleep fundamentals and sleep disorders (TS) questions: neurobiological (neuroanatomical, neurochemical and physiological); clinical (anamnesis and physical examination; subjective exams - questionnaires and scales; objective examinations - polysomnography, multiple latency tests and actigraphy). The third International Classification of Sleep Disorders (ICSD-3) is valued to address clinical, diagnostic and therapeutic aspects, according to the four main complaints regarding TS: Insomnia, Excessive daytime drowsiness, Abnormal movements and behaviors during sleep, and Inability to sleep at the desired time. In this paper, it is discussed the only first two: 1-Insomnia: difficulty falling as-leep, staying asleep, early morning waking, non- restorative sleep, quality of sleep, and amount of sleep; duration: acute or chronic. (AU)

Humans , Sleep Wake Disorders/classification , Sleep Wake Disorders/diagnosis , Sleep Wake Disorders/drug therapy , Polysomnography/methods , Sleep Disorders, Circadian Rhythm/diagnosis , Sleep Initiation and Maintenance Disorders/diagnosis , Sleep Initiation and Maintenance Disorders/drug therapy
Clinics ; 71(1): 5-9, Jan. 2016. tab
Article in English | LILACS | ID: lil-771945


OBJECTIVE: To determine the therapeutic effects of two selective GABA-A agonists, zopiclone and eszopiclone, in the treatment of insomnia. METHODS: This study comprised a phase III, single-center, randomized, double-blind, double-dummy, parallel-group, non-inferiority trial. Patients were randomized to receive zopiclone 7.5 mg or eszopiclone 3 mg, both orally, for four weeks. In total, 199 patients were evaluated during two visits and then followed for at least six weeks. The primary endpoint was the Insomnia Severity Index after four weeks of treatment. Secondary endpoints were obtained through polysomnography data, including total sleep time, sleep latency and sleep efficiency. The frequency of adverse events was also analyzed. NCT01100164. RESULTS: The primary efficacy analysis demonstrated the non-inferiority of eszopiclone over zopiclone. Analysis of objective parameters assessed by polysomnography showed that eszopiclone increased total sleep time and also improved sleep efficiency. The safety profile of both study treatments was similar and the most common events reported in both groups were dysgeusia, headache, dizziness, irritability and nausea. Adverse events were observed in 223 patients, 109 (85.2%) in the eszopiclone group and 114 (87.7%) in the zopiclone group. CONCLUSION: Based on the Insomnia Severity Index at the end of four weeks of treatment, eszopiclone demonstrated efficacy comparable to that of zopiclone in the treatment of insomnia, increasing total sleep time as well as sleep efficiency according to polysomnography.

Adult , Female , Humans , Male , Middle Aged , Young Adult , Azabicyclo Compounds/therapeutic use , Eszopiclone/therapeutic use , Hypnotics and Sedatives/therapeutic use , Piperazines/therapeutic use , Sleep Initiation and Maintenance Disorders/drug therapy , Azabicyclo Compounds/adverse effects , Double-Blind Method , Dysgeusia/chemically induced , Eszopiclone/adverse effects , Headache/chemically induced , Hypnotics and Sedatives/adverse effects , Polysomnography , Piperazines/adverse effects , Treatment Outcome
Braz. oral res. (Online) ; 30(1): e126, 2016. tab, graf
Article in English | LILACS | ID: biblio-952071


Abstract Insomnia is becoming increasingly prevalent in the world general population. Therapies used by patients include over-the-counter therapies, herbal and dietary supplements, and pharmacological or nonpharmacological treatments. Among these, zolpidem is a pharmacological treatment popularly used for insomnia. Zolpidem is well tolerated and especially efficacious for initiation of sleep, and therefore is effective for the treatment of sleep-onset insomnia. The purpose of the present study was to design and evaluate zolpidem nanoparticle-impregnated buccal films to prolong the duration of its action. Zolpidem nanospheres were prepared by double emulsion solvent evaporation and then loaded into buccoadhesive films (Z1-Z4) comprised of different concentrations of HPMC K100, Eudragit® RL 100, and carbopol 974P. The prepared films were characterized for physicomechanical properties, mucoadhesion, percent hydration, in vitro drug release, ex vivo permeation, and in vivo studies. In vitro drug release was found to depend upon film composition. Ex vivo studies showed that film Z4 had the highest flux. In vivo studies revealed that administration of zolpidem nanosphere-impregnated film enhanced absorption of the drug (p < 0.0001), with a higher peak plasma concentration (52.54 ± 8.22 ng/mL) and area under the curve from time 0 to α (236.00 ± 39.51 ng.h/mL) than oral administration. The increase in time taken to reach the maximum drug concentration (1.5 h) further signifies the potential of these films to provide prolonged drug release. Given these promising results, we concluded that these buccal films could be an alternative route for effective zolpidem delivery.

Animals , Male , Pyridines/administration & dosage , Acrylic Resins/administration & dosage , Drug Delivery Systems/methods , Nanospheres/administration & dosage , Hypnotics and Sedatives/administration & dosage , Pyridines/pharmacokinetics , Rabbits , Reference Values , Time Factors , Acrylic Resins/pharmacokinetics , Water/chemistry , Biological Availability , Microscopy, Electron, Scanning , Administration, Oral , Reproducibility of Results , Treatment Outcome , Zolpidem , Hypnotics and Sedatives/pharmacokinetics , Sleep Initiation and Maintenance Disorders/drug therapy
Trends psychiatry psychother. (Impr.) ; 37(1): 47-50, Jan-Mar/2015. graf
Article in English | LILACS | ID: lil-742994


Objective: Psychiatric symptoms emerge in the early stages of anti-N-methyl-D-aspartate receptor (anti-NMDAR) encephalitis, and patients often seek treatment in psychiatric departments before visiting any other general medical services. Numerous articles about anti-NMDAR encephalitis have been published in the scientific community worldwide, but few emphasize the role of psychiatry in symptom management. Case description: We describe the case of a patient with anti- -NMDAR encephalitis seen in our service and discuss the management of behavioral symptoms based on current scientific literature. High doses of atypical antipsychotics and benzodiazepines were used to control agitation, and trazodone was administered to treat insomnia. Comments: Consultation-liaison psychiatry may help the healthcare team adjust the management of neuropsychiatric complications that might affect inpatients with anti-NMDAR encephalitis. .

Objetivo: Sintomas psiquiátricos surgem em estágios precoces da encefalite antirreceptor N-metil-D-aspartato (NMDAR), o que faz muitos pacientes procurarem tratamento em serviços de psiquiatria antes de se dirigirem a unidades de clínica geral. Embora muitos artigos sobre encefalite anti-NMDAR venham sendo publicados na comunidade científica internacional, poucos enfatizam o papel do psiquiatra no seu manejo sintomatológico. Descrição do caso: O presente artigo relata o caso de um paciente que desenvolveu encefalite anti-NMDAR em nosso serviço e discute manejo de alterações comportamentais com base na literatura científica atual. Altas doses de antipsicóticos atípicos e benzodiazepínicos foram usados para controle de agitação, e trazodona foi utilizada para tratar insônia. Comentários: A interconsulta psiquiátrica pode ajudar no ajuste de condutas de toda a equipe assistente para as complicações neuropsiquiátricas que possam surgir na evolução de pacientes internados por encefalite anti-NMDAR. .

Humans , Male , Adult , Anti-N-Methyl-D-Aspartate Receptor Encephalitis/psychology , Anti-N-Methyl-D-Aspartate Receptor Encephalitis/drug therapy , Anti-N-Methyl-D-Aspartate Receptor Encephalitis/physiopathology , Psychomotor Agitation/drug therapy , Psychomotor Agitation/physiopathology , Psychotropic Drugs/therapeutic use , Sleep Initiation and Maintenance Disorders/drug therapy , Sleep Initiation and Maintenance Disorders/physiopathology
Rev. psiquiatr. Urug ; 77(1): 20-31, jul. 2013. ilus, tab
Article in Spanish | LILACS | ID: lil-723543


Se ha demostrado que las funciones fisiológicas oscilan durante ciclos de 24 horas (circadianos), menos de 24 horas (ultradianos) y mayores de 24 horas (infradianos), lo que se denomina ritmos biológicos (cronobiología). El presente artículo hace énfasis en cómo los ritmos biológicos pueden incidir en la respuesta a los medicamentos y la terapéutica psiquiátrica (cronofarmacología, cronoterapia). Esta variable de estudio podría ofrecer nuevos márgenes en la eficacia y seguridad de los medicamentos y hacer su uso más racional.

It has been shown that physiological functions oscillate during cycles of 24 hours (circadian), of less than 24 (ultradian) and larger than 24 hours (infradian). These are called biological rhythms (chronobiology). This article emphasizes on how biological rhythms may influence response to drugs and psychiatric treatment (chronopharmacology, chronotherapy). The study of this variable could offer new perspectives on efficacy and safety of drugs in order to pursue a more rational use of them.

Humans , Drug Chronotherapy , Psychopharmacology/methods , Biological Clocks , Depression/drug therapy , Sleep Initiation and Maintenance Disorders/drug therapy
Article in English | WPRIM | ID: wpr-86101


OBJECTIVES: To evaluate the risk of fractures related with zolpidem in elderly insomnia patients. METHODS: Health claims data on the entire South Korean elderly population from January 2005 to June 2006 were extracted from the Health Insurance Review and Assessment Service database. We applied a case-crossover design. Cases were defined as insomnia patients who had a fracture diagnosis. We set the hazard period of 1 day length prior to the fracture date and four control periods of the same length at 5, 10, 15, and 20 weeks prior to the fracture date. Time independent confounding factors such as age, gender, lifestyle, cognitive function level, mobility, socioeconomic status, residential environment, and comorbidity could be controlled using the casecrossover design. Time dependent confounding factors, especially co-medication of patients during the study period, were adjusted by conditional logistic regression analysis. The odds ratios and their 95% confidence intervals (CIs) were estimated for the risk of fracture related to zolpidem. RESULTS: One thousand five hundred and eight cases of fracture were detected in insomnia patients during the study period. In our data, the use of zolpidem increased the risk of fracture significantly (adjusted odds ratio [aOR], 1.72; 95% CI, 1.37 to 2.16). However, the association between benzodiazepine hypnotics and the risk of fracture was not statistically significant (aOR, 1.00; 95% CI, 0.83 to 1.21). Likewise, the results were not statistically significant in stratified analysis with each benzodiazepine generic subgroup. CONCLUSIONS: Zolpidem could increase the risk of fracture in elderly insomnia patients. Therefore zolpidem should be prescribed carefully and the elderly should be provided with sufficient patient education.

Aged , Aged, 80 and over , Benzodiazepines/adverse effects , Cross-Over Studies , Female , Fractures, Bone/chemically induced , Humans , Hypnotics and Sedatives/adverse effects , Male , Odds Ratio , Pyridines/adverse effects , Republic of Korea/epidemiology , Risk Assessment , Risk Factors , Sleep Initiation and Maintenance Disorders/drug therapy
Rev. bras. neurol ; 47(1)jan.-mar. 2011. tab
Article in Portuguese | LILACS | ID: lil-589453


Introdução: O processo de envelhecimento gera mudanças nas características do sono. Pessoas idosas se queixam, com freqüência, de distúrbios do sono. Entretanto, independentemente da idade, o sono restaurador é essencial para o bem estar físico e emocional. Objetivos: Reconhecer aspectos relacionados à qualidade, quantidade e características macroscópicas do sono pela análise polissonográfica, além de identificar seus fatores causais, conseqüências, comorbidades e aspectos diagnósticos e terapêuticos no envelhecimento. Metodologia: Revisão baseada em 20 artigos obtidos em busca realizada no Pubmed (18) com os descritores sleep e aging ou ageing nos títulos, em humanos, e nos últimos cinco anos, além de 2 artigos síntese de fiopatogenia ou clínica do sono com a participação dos autores. Resultados: Dos 20 artigos, onze são originais, e nove são de revisão sendo a abordagem primordial sobre aspectos sócio-econômicos, clínicos e fisiopatogênicos. Conclusões: Há alterações na qualidade, quantidade e arquitetura do sono com o envelhecimento, podendo existir em conseqüência, aumento da mortalidade, comprometimento da saúde física e mental, além de prejuízos econômicos. Possíveis mecanismos vinculados a essas alterações incluem modulação circadiana, fatores homeostáticos, funções cardiopulmonar e endócrina e situação sócio-econômica. Os transtornos do sono estão significativamente associados a diferentes comorbidades clínicas e mentais incrementadas com o envelhecer.

Introduction: The ageing process produces changes in sleep structure. Older people complain more often or sleep disturbances. However, regardless of age, restorative sleep is essential for the well being, physically and emotionally. Objectives: Recognize aspects related to the quality, amount and macroscopic characteristics of sleep by polysomnographic analysis, and identify their causal factors, consequences, comorbidities, diagnostic and therapeutic. Methods: Review based on 18 articles obtained in search on Pubmed using the keywords "sleep", "aging" or "ageing", in humans, in the last five years, beyond two articles of synthesis about physiopathology of the sleep or sleep clinics with participation of the Authors. Results: Among 20 articles, 11 are original and nine review. The main approach is about its socioeconomic, clinical and physiopathologic aspects. Conclusions: Alterations in the structure, quality and amount of sleep, in ageing people can be verified. The aging process accompanied by significant changes in normal patterns of sleep evolve to increased mortality, impaired physical and mental health, as well as economic losses.

Humans , Male , Aged , Sleep Initiation and Maintenance Disorders/drug therapy , Aging/physiology , Narcolepsy , Sleep Disorders, Circadian Rhythm , Sleep Wake Disorders/physiopathology , Sleep Stages , Socioeconomic Factors
Braz. dent. j ; 22(5): 415-421, 2011. tab
Article in English | LILACS | ID: lil-601844


The aim of this pilot study was to evaluate the effectiveness of cognitive-behavioral therapy (CBT) and use of amitriptyline, a tricyclic antidepressant, in patients with chronic temporomandibular disorders (TMD). Forty-seven women (mean age = 35.4 years old) with chronic TMD were enrolled in the study and divided into 4 groups: amitriptyline; amitriptyline and CBT; placebo and CBT; and placebo only (control). Patients were managed for 7 consecutive weeks. Follow-up evaluations were done at the 1st, 7th and 11th weeks of treatment. The presence and severity of pain, levels of depression, and quality of life and sleep were measured. Data were analyzed using ANOVA, Chi-square and Cochran tests, considering a significance level of 5 percent. Improvements were found for all factors considered in the intragroup analysis, although no significant differences were detected among groups. However, at the end of the treatment (11 weeks of follow-up), these positive outcomes persisted only for the women treated with amitriptyline and CBT. The obtained results suggest that the combination of amitriptyline and CBT may be effective in reducing pain and depression levels as well as in improving the quality of life and sleep in patients with chronic TMD.

O objetivo deste estudo piloto foi avaliar a eficácia do uso de uma terapia cognitivo comportamental (TCC) e da amitriptilina, um antidepressivo tricíclico, no tratamento de pacientes portadores de disfunções temporomandibulares (DTM) crônicas. Quarenta e sete mulheres (com 35,4 anos em média) diagnosticadas com DTM crônica foram selecionadas e divididas em 4 grupos: amitriptilina; amitriptilina + TCC; placebo + TCC; e placebo (controle) e controle. As pacientes foram submetidas às terapias por 7 semanas consecutivas. As reavaliações aconteceram 1, 7 e 11 semanas após o início da terapia (11 semanas de avaliações). Foram avaliados a presença e severidade de dor, o nível de depressão, a qualidade de vida e do sono. Os dados foram avaliados através de ANOVA, Qui-quadrado e teste de Cochran, considerando um nível de significância de 5 por cento. Foram observadas melhoras significantes em todos os fatores avaliados para todos os grupos, porém não foram observadas diferenças entre os grupos. Após o final da terapia, os resultados positivos persistiram apenas para o grupo amitriptilina + TCC. Os resultados sugerem que o uso associado de amitriptilina e TCC no tratamento de pacientes portadores de DTM crônicas pode ser efetivo na melhora da dor, nível de depressão, qualidade de vida e do sono.

Adolescent , Adult , Female , Humans , Middle Aged , Young Adult , Amitriptyline/therapeutic use , Antidepressive Agents, Tricyclic/therapeutic use , Cognitive Behavioral Therapy , Temporomandibular Joint Disorders/therapy , Chronic Pain/classification , Chronic Pain/drug therapy , Chronic Pain/therapy , Depression/classification , Depression/drug therapy , Depression/therapy , Follow-Up Studies , Pain Measurement , Pilot Projects , Placebos , Quality of Life , Sleep Initiation and Maintenance Disorders/drug therapy , Sleep Initiation and Maintenance Disorders/therapy , Sleep/drug effects , Sleep/physiology , Treatment Outcome , Temporomandibular Joint Disorders/classification , Temporomandibular Joint Disorders/drug therapy
Rev. bras. psiquiatr ; 32(3): 288-293, Sept. 2010. tab
Article in Portuguese | LILACS | ID: lil-560784


Nas últimas décadas houve um esforço para o desenvolvimento de hipnóticos mais seguros e eficazes. Zolpidem, zaleplona, zopiclona, eszopiclona (drogas-z) e indiplona são moduladores do receptor GABA-A, os quais agem de forma seletiva na subunidade α1, exibindo, desta forma, mecanismos similares de ação, embora evidências recentes sugiram que a eszopiclona não seja tão seletiva para a subunidade α1 quanto o zolpidem. Ramelteon e tasimelteon são novos agentes crono-hipnóticos seletivos para os receptores de melatonina MT1 e MT2. Por outro lado, nos últimos anos, o consumo de drogas antidepressivas sedativas tem aumentado significativamente no tratamento da insônia. Como droga experimental, a eplivanserina tem sido testada como um potente agonista inverso do subtipo 5-HT2A da serotonina, com um uso potencial na dificuldade da manutenção do sono. Outro agente farmacológico para o tratamento da insônia é o almorexant, o qual apresenta um novo mecanismo de ação envolvendo antagonismo do sistema hipocretinérgico, desta forma levando à indução do sono. Finalmente, também discutiremos o potencial papel de outras drogas gabaérgicas no tratamento da insônia.

There has been a search for more effective and safe hypnotic drugs in the last decades. Zolpidem, zaleplon, zopiclone, eszopiclone (the z-drugs) and indiplon are GABA-A modulators which bind selectively α1 subunits, thus, exhibiting similar mechanisms of action, although recent evidence suggests that eszopiclone is not as selective for α1 subunit as zolpidem is. Ramelteon and tasimelteon are new chrono-hypnotic agents, selective for melatonin MT1 and MT2 receptors. On the other hand, the consumption of sedative antidepressant drugs is significantly increasing for the treatment of insomnia, in the last years. As an experimental drug, eplivanserin is being tested as a potent antagonist of serotonin 2-A receptors (ASTAR) with a potential use in sleep maintenance difficulty. Another recent pharmacological agent for insomnia is almorexant, which new mechanism of action involves antagonism of hypocretinergic system, thus inducing sleep. Finally we also discuss the potential role of other gabaergic drugs for insomnia.

Humans , Antidepressive Agents/therapeutic use , GABA Agonists/therapeutic use , Hypnotics and Sedatives/therapeutic use , Receptor, Melatonin, MT1/agonists , /agonists , Sleep Initiation and Maintenance Disorders/drug therapy