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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
Assuntos
Humanos , Masculino , Feminino , Adulto , Medicamentos Indutores do Sono/administração & dosagem , Distúrbios do Início e da Manutenção do Sono/tratamento farmacológico , Administração Sublingual , Método Duplo-Cego , Administração Oral , Estudos Prospectivos , Resultado do Tratamento , Polissonografia , Zolpidem/administração & dosagem , Pessoa de Meia-IdadeRESUMO
PURPOSE: The aim of this study was to clinically characterize sleep disorders in a cohort of Niemann-Pick type C (NPC) patients, correlating these findings with disease features and polysomnographic (PSG) results. METHODS: We evaluated eight consecutive patients with molecular confirmation of NPC followed at the Hospital Geral de Fortaleza. Patients underwent a comprehensive neurological and sleep evaluation. Four participants underwent polysomnography and then performed the multiple sleep latency test. RESULTS: All eight patients evaluated had sleep disorders. Four participants performed polysomnography followed by multiple sleep latency test. Chronic insomnia and Obstructive Sleep Apnea (OSA) were the most frequent sleep disorders (62,5%). Two patients were diagnosed with Restless Legs Syndrome (RLS) (25%) and two with probable REM sleep behavior disorder (RBD) (25%). All the patients who did polysomnography had reduced and/or disorganized sleep, with reduction on sleep efficiency, total sleep time and REM sleep time. CONCLUSION: Our results suggest that sleep abnormalities in Niemann-Pick type C patients may be more prevalent than previously thought.
Assuntos
Doença de Niemann-Pick Tipo C , Transtorno do Comportamento do Sono REM/diagnóstico , Síndrome das Pernas Inquietas/diagnóstico , Apneia Obstrutiva do Sono/diagnóstico , Distúrbios do Início e da Manutenção do Sono/diagnóstico , Adulto , Cataplexia , Estudos de Coortes , Feminino , Humanos , Masculino , Doença de Niemann-Pick Tipo C/complicações , Doença de Niemann-Pick Tipo C/fisiopatologia , Polissonografia , Latência do SonoRESUMO
Daytime and nighttime symptoms of posttraumatic stress disorder (PTSD) are common among combat veterans and military service members. However, there is a great deal of heterogeneity in how symptoms are expressed. Clarifying the heterogeneity of daytime and nighttime PTSD symptoms through exploratory clustering may generate hypotheses regarding ways to optimally match evidence-based treatments to PTSD symptom profiles. We used mixture modeling to reveal clusters based on six daytime and nighttime symptoms of 154 combat veterans with insomnia and varying levels of PTSD symptoms. Three clusters with increasing symptom severity were identified (N1=50, N2=70, N3=34). These results suggest that, among veterans with insomnia, PTSD symptoms tend to exist on a continuum of severity, rather than as a categorical PTSD diagnosis. Hypotheses regarding possible targeted treatment strategies for veterans within each identified cluster, as well as ways to generalize these methods to other groups within the military, are discussed.
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OBJECTIVE: To evaluate the impact of nocturia on the therapeutic response of chronic insomnia to behavioral treatment in older adults. METHODS: Secondary analysis of a randomized clinical trial designed to assess the efficacy of brief behavioral treatment of insomnia (BBTI) vs. an information-only control (IC) in 79 community-dwelling older adults with chronic insomnia. For the current analysis, participants were stratified into 2 groups: those with self-reported nocturia at baseline i.e., ≥ 1 void/night (N = 30; 16 IC, 14 BBTI) and those without nocturia (N = 49; 24 IC, 25 BBTI). We then determined the impact of BBTI on sleep, sleep quality, and nocturia as assessed by self-report, actigraphy, and polysomnography. RESULTS: Individuals without baseline nocturia responded well to BBTI with significant decrease in sleep latency, wake after sleep onset, and total sleep time assessed by sleep diary and actigraphy; these changes were significantly greater than those in the IC group. In comparison, changes in the same sleep parameters among participants with nocturia were not significantly different from the IC control. Although BBTI showed significant improvement in sleep quality in groups with and without nocturia (as assessed by PSQI and sleep diary), the effect size of these improvements was larger in those without nocturia than in those with nocturia (PSQI d = 0.82 vs. 0.53, diary sleep quality d = 0.83 vs. 0.51). CONCLUSIONS: These secondary analyses suggest that brief behavioral treatment of insomnia may be more efficacious in improving insomnia in participants without nocturia. Addressing nocturia may improve the efficacy of behavioral insomnia treatment.
Assuntos
Terapia Comportamental , Noctúria/complicações , Distúrbios do Início e da Manutenção do Sono/complicações , Distúrbios do Início e da Manutenção do Sono/terapia , Actigrafia , Idoso , Doença Crônica/psicologia , Doença Crônica/terapia , Feminino , Humanos , Masculino , Polissonografia , Psicoterapia Breve , Autorrelato , Sono/fisiologia , Distúrbios do Início e da Manutenção do Sono/etiologia , Distúrbios do Início e da Manutenção do Sono/psicologiaRESUMO
Introducción: el insomnio, especialmente cuando se cronifica, se convierte en una patología con marcadas implicaciones en la salud física y mental. No obstante su importancia, en nuestro país existen pocos estudios poblacionales sobre su comportamiento epidemiológico. Estudios previos realizados en el departamento de Caldas mostraron una elevada prevalencia de insomnio global con cifras alrededor de 47%. Objetivo: establecer la frecuencia, características sociodemográficas y persistencia a dos años del insomnio crónico, en una muestra poblacional representativa de la ciudad de Manizales. Sujetos y métodos: estudio transversal mediante entrevista domiciliaria en diferentes estratos socioeconómicos en mayores de 18 años, con queja de insomnio en el estudio previo de trastornos de sueño en Caldas (2008), que incluyó 530 personas de las cuales 228 tenían insomnio (agudo o crónico), lo cual arrojó una prevalencia global de 43.9%. Para el análisis de la información se empleó el paquete estadístico Epiinfo 6.04d/. Resultados: el seguimiento a dos años se pudo realizar a 218 personas, y de éstas el insomnio continuaba en 175, lo cual indicó una prevalencia de insomnio crónico de 33% y una persistencia del mismo de 80.2%. Cuando sólo se estimó el insomnio con repercusión diurna la prevalencia fue de 10.9%. En más de la mitad de los individuos el insomnio había estado presente entre cinco y diez años. El aumento en edad fue el único factor asociado para una mayor frecuencia. A pesar de la persistencia y severidad del insomnio, sólo 18.3% lo habían informado al médico. Conclusiones: las prevalencias halladas de insomnio global, crónico y con repercusión diurna se encuentran entre los rangos mencionados en la literatura y se detectó una elevada persistencia y duración del insomnio crónico. Lo anterior, y dadas sus consecuencias negativas sobre individuos y comunidades, amerita una búsqueda activa de esta condición en la práctica clínica y medidas gubernamentales apropiadas para su prevención y manejo (Acta Med Colomb 2011; 36: 119-124).
Introduction: insomnia, especially when it becomes chronic, it becomes a disease with marked implications for physical and mental health. Despite its importance, in our country there are few population studies on the epidemiological pattern. Previous studies in the Department of Caldas showed a high overall prevalence of insomnia with figures around 47%. Objective: To establish the frequency, demographic characteristics and persistence to two years of chronic insomnia in a population sample representative of the city of Manizales. Subjects and Methods: A cross-sectional household interviews in different socioeconomic levels in subjects over 18 years, complaining of insomnia in the previous study of sleep disorders in Caldas (2008) that included 530 people of which 228 were insomnia (acute or chronic), yielding an overall prevalence of 43.9%. For data analysis we used the statistical package EpiInfo 6.04 /. Results: The 2-year follow-up could be performed and of these 218 people remained in 175 insomnia, which indicated a prevalence of chronic insomnia of 33% and a persistence of the same of 80.2%. When only considered daytime consequences of the insomnia, the prevalence was 10.9%. In more than half of those insomnia had been present between five and ten years. Increasing age was the only factor associated to a higher frequency. Despite the persistence and severity of insomnia, only 18.3% had reported to the doctor. Conclusions: The overall prevalence of insomnia, chronic and daytime impact are found within the ranges reported in the literature and found a high persistence and duration of chronic insomnia. Above, and given its negative consequences on individuals and communities, warrants an active search for this condition in clinical practice and appropriate government measures for its prevention and management (Acta Med Colomb 2011; 36: 119-124).