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1.
Cochrane Database Syst Rev ; (7): CD006239, 2014 Jul 08.
Artículo en Inglés | MEDLINE | ID: mdl-25001071

RESUMEN

BACKGROUND: Post-traumatic stress disorder (PTSD) is a debilitating disorder which, after a sufficient delay, may be diagnosed amongst individuals who respond with intense fear, helplessness or horror to traumatic events. There is some evidence that the use of pharmacological interventions immediately after exposure to trauma may reduce the risk of developing of PTSD. OBJECTIVES: To assess the effects of pharmacological interventions for the prevention of PTSD in adults following exposure to a traumatic event. SEARCH METHODS: We searched the Cochrane Depression, Anxiety and Neurosis Controlled Trials Register (CCDANCTR-Studies and CCDANCTR-References) (to 14 February 2014). This register contains relevant reports of randomised controlled trials from the following bibliographic databases: CENTRAL (all years); EMBASE (1974 to date); MEDLINE (1950 to date) and PsycINFO (1967 to date). We identified unpublished trials by searching the National Institute of Health (NIH) Reporter, the metaRegister of Controlled Trials database (mRCT) and the WHO International Clinical Trials Registry Platform (to December 2013). We scanned the reference lists of articles for additional studies. We placed no constraints on language and setting. SELECTION CRITERIA: We restricted studies to randomised controlled trials (RCTs) of pharmacological interventions compared with placebo for the prevention of PTSD in adults. DATA COLLECTION AND ANALYSIS: Two authors (TA and JI) independently assessed trials for eligibility and inclusion based on the review selection criteria. We independently extracted sample, methodological, outcome and 'Risk of bias' data, as well as the number of side effects, from each trial and entered these into a customised data extraction form. We contacted investigators for missing information. We calculated summary statistics for continuous and dichotomous variables (if provided). We did not undertake subgroup analyses due to the small number of included studies. MAIN RESULTS: We included nine short-term RCTs (duration 12 weeks or less) in the analysis (345 participants; age range 18 to 76 years). Participants were exposed to a variety of traumas, ranging from assault, traffic accidents and work accidents to cardiac surgery and septic shock. Seven studies were conducted at single centres. The seven RCTs included four hydrocortisone studies, three propranolol studies (of which one study had a third arm investigating gabapentin), and single trials of escitalopram and temazepam. Outcome assessment measures included the Clinician-Administered PTSD Scale (CAPS), the 36-Item Short-Form Health Survey (SF-36) and the Center for Epidemiological Studies - Depression Scale (CES-D).In four trials with 165 participants there was moderate quality evidence for the efficacy of hydrocortisone in preventing the onset of PTSD (risk ratio (RR) 0.17; 95% confidence interval (CI) 0.05 to 0.56; P value = 0.004), indicating that between seven and 13 patients would need to be treated with this agent in order to prevent the onset of PTSD in one patient. There was low quality evidence for preventing the onset of PTSD in three trials with 118 participants treated with propranolol (RR 0.62; 95% CI 0.24 to 1.59; P value = 0.32). Drop-outs due to treatment-emergent side effects, where reported, were low for all of the agents tested. Three of the four RCTs of hydrocortisone reported that medication was more effective than placebo in reducing PTSD symptoms after a median of 4.5 months after the event. None of the single trials of escitalopram, temazepam and gabapentin demonstrated evidence that medication was superior to placebo in preventing the onset of PTSD.Seven of the included RCTs were at a high risk of bias. Differential drop-outs between groups undermined the results of three studies, while one study failed to describe how the allocation of medication was concealed. Other forms of bias that might have influenced study results included possible confounding through group differences in concurrent medication and termination of the study based on treatment response. AUTHORS' CONCLUSIONS: There is moderate quality evidence for the efficacy of hydrocortisone for the prevention of PTSD development in adults. We found no evidence to support the efficacy of propranolol, escitalopram, temazepam and gabapentin in preventing PTSD onset. The findings, however, are based on a few small studies with multiple limitations. Further research is necessary in order to determine the efficacy of pharmacotherapy in preventing PTSD and to identify potential moderators of treatment effect.


Asunto(s)
Trastornos por Estrés Postraumático/prevención & control , Antagonistas de Receptores Adrenérgicos beta 1/uso terapéutico , Adulto , Anciano , Aminas/uso terapéutico , Ansiolíticos/uso terapéutico , Antiinflamatorios/uso terapéutico , Antidepresivos de Segunda Generación/uso terapéutico , Citalopram/uso terapéutico , Ácidos Ciclohexanocarboxílicos/uso terapéutico , Gabapentina , Humanos , Hidrocortisona/uso terapéutico , Persona de Mediana Edad , Propranolol/uso terapéutico , Ensayos Clínicos Controlados Aleatorios como Asunto , Temazepam/uso terapéutico , Adulto Joven , Ácido gamma-Aminobutírico/uso terapéutico
2.
Australas Psychiatry ; 20(4): 301-4, 2012 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-22773413

RESUMEN

OBJECTIVE: The objective of this article is to examine patterns of temazepam prescribing amongst inpatients at a Sydney teaching hospital. METHOD: The study involved a retrospective file audit of 98.8% (n=410) of patients discharged from psychiatry, medical, surgical and obstetric and gynaecology wards of Nepean Hospital during a one-week period. Data was collected on patient demographics, temazepam and other sedative-hypnotic use, falls risk and analgesia use. RESULTS: Sixteen per cent (n=64) of patients were prescribed temazepam during their stay. All patients from the psychiatry wards had been prescribed temazepam. Fifteen per cent (n=6) of falls risk patients had been prescribed temazepam. Temazepam prescription was associated with an increased length of stay, psychiatry and surgical wards, and higher use of analgesia. CONCLUSIONS: Temazepam continues to be a frequently prescribed medication in the acute psychiatry setting. Its frequent prescription to patients in surgical wards and to those prescribed analgesic agents indicates that it still has a role in settling patients to sleep in the hospital setting.


Asunto(s)
Accidentes por Caídas , Hipnóticos y Sedantes/uso terapéutico , Pautas de la Práctica en Medicina/estadística & datos numéricos , Trastornos del Sueño-Vigilia/tratamiento farmacológico , Temazepam/uso terapéutico , Adulto , Anciano , Analgésicos/uso terapéutico , Femenino , Hospitales de Enseñanza , Humanos , Pacientes Internos/estadística & datos numéricos , Tiempo de Internación , Masculino , Persona de Mediana Edad , Nueva Gales del Sur , Estudios Retrospectivos
3.
J Sleep Res ; 20(4): 526-32, 2011 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-21668806

RESUMEN

Centrally active agents have a variable impact in patients with obstructive sleep apnoea (OSA) that is unexplained. How to phenotype the individual OSA response is clinically important, as it may help to identify who will be at risk of respiratory depression and who will benefit from a centrally active agent. Based on loop gain theory, we hypothesized that OSA patients with higher central chemosensitivity have higher breathing instability following the use of a hypnosedative, temazepam. In 20 men with OSA in a double-blind, placebo-controlled cross-over trial we tested the polysomnographically (PSG) measured effects of temazepam 10 mg versus placebo on sleep apnoea. Treatment nights were at least 1 week apart. Ventilatory chemoreflexes were also measured during wakefulness in each subject. The patients (mean ± standard deviation; 44 ± 12 years) had predominantly mild-to-moderate OSA [baseline apnoea-hypopnoea index (AHI) = 16.8 ± 14.1]. Patients' baseline awake central chemosensitivity correlated significantly with both the change of SpO2 nadir between temazepam and placebo (r = -0.468, P = 0.038) and oxygen desaturation index (ODI; r = 0.485, P = 0.03), but not with the change of AHI (r = 0.18, P = 0.44). Peripheral chemosensitivity and ventilatory recruitment threshold were not correlated with the change of SpO2 nadir, ODI or AHI (all P > 0.05). Mild-moderate OSA patients with higher awake central chemosensitivity had greater respiratory impairment during sleep with temazepam. Relatively simple daytime tests of respiratory control may provide a method of determining the effect of sedative-hypnotic medication on breathing during sleep in OSA patients.


Asunto(s)
Hipnóticos y Sedantes/uso terapéutico , Respiración/efectos de los fármacos , Apnea Obstructiva del Sueño/tratamiento farmacológico , Temazepam/uso terapéutico , Vigilia/fisiología , Adulto , Estudios Cruzados , Método Doble Ciego , Humanos , Masculino , Fenotipo , Polisomnografía , Sueño/efectos de los fármacos , Sueño/fisiología , Apnea Obstructiva del Sueño/fisiopatología
4.
BMJ Open ; 9(5): e025514, 2019 05 22.
Artículo en Inglés | MEDLINE | ID: mdl-31122969

RESUMEN

INTRODUCTION: Hospitalised older patients frequently suffer from inadequate sleep, which can lead to patient distress and delayed recovery from acute illness or surgical procedure. Currently, no evidence-based treatments exist for sleeping problems in hospitalised older patients. Benzodiazepines, such as temazepam, are regularly prescribed by physicians, although they have serious side effects; for older patients in particular. Melatonin is proposed as a safe alternative for sleeping problems in hospitalised older patients, but the efficacy of melatonin is unclear in this population. Therefore, the aim of this study is to investigate the effects of melatonin and temazepam compared with placebo on sleep quality among hospitalised older patients with sleeping problems. METHODS AND ANALYSIS: This study is a multicentre, randomised, placebo-controlled trial. A total of 663 patients will be randomised in a 1:1:1 fashion to receive either melatonin (n=221), temazepam (n=221) or placebo (n=221). The study population consists of hospitalised patients aged 60 years and older, with new or aggravated sleeping problems for which an intervention is needed. The primary outcome is sleep quality measured with the Leeds Sleep Evaluation Questionnaire (LSEQ). Secondary outcomes include sleep parameters measured with actigraphy and medication-related adverse effects. ETHICS AND DISSEMINATION: This study was approved by the Medical Ethics Committee of the Academic Medical Centre Amsterdam, (No 2015_302). Study findings will be disseminated through presentations at professional and scientific conferences and publications in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NTR6908; Pre-results.


Asunto(s)
Preparaciones de Acción Retardada/uso terapéutico , Geriatría , Hipnóticos y Sedantes/uso terapéutico , Melatonina/uso terapéutico , Trastornos del Sueño-Vigilia/tratamiento farmacológico , Temazepam/uso terapéutico , Anciano , Nivel de Alerta/efectos de los fármacos , Preparaciones de Acción Retardada/farmacología , Hospitalización , Humanos , Hipnóticos y Sedantes/farmacología , Melatonina/farmacología , Persona de Mediana Edad , Placebos , Ensayos Clínicos Controlados Aleatorios como Asunto , Sueño/efectos de los fármacos , Temazepam/farmacología , Resultado del Tratamiento
6.
High Alt Med Biol ; 9(3): 195-8, 2008.
Artículo en Inglés | MEDLINE | ID: mdl-18800955

RESUMEN

Given the well-established problems with sleep at high altitude, it is not uncommon for people planning trips to the mountains to seek advice from clinicians regarding pharmacologic options for improving sleep during their trip. This review article considers the various medications that have been studied for this purpose at high altitude with an emphasis on both their efficacy and safety. The available data support the use of either acetazolamide, temazepam, zolpidem or zaleplon in this environment. Other agents commonly used at sea-level such as eszopiclone and diphenhydramine have not been studied at high altitude but are likely safe to use given their mechanism of action and known side effects. Limited evidence suggests diazepam may cause hypoventilation at high altitude and its use in this environment should be discouraged. Insufficient data exist to determine which agent is most effective at altitude nor do we know whether combination therapy with acetazolamide and a hypnotic agent offers any benefits over monotherapy.


Asunto(s)
Mal de Altura/fisiopatología , Ansiolíticos/uso terapéutico , Agonistas del GABA/uso terapéutico , Hipnóticos y Sedantes/uso terapéutico , Montañismo , Trastornos del Inicio y del Mantenimiento del Sueño/tratamiento farmacológico , Acetamidas/uso terapéutico , Acetazolamida/uso terapéutico , Compuestos de Azabiciclo/uso terapéutico , Benzodiazepinas/uso terapéutico , Difenhidramina/uso terapéutico , Eszopiclona , Humanos , Piperazinas/uso terapéutico , Piridinas/uso terapéutico , Pirimidinas/uso terapéutico , Fases del Sueño/efectos de los fármacos , Temazepam/uso terapéutico , Vigilia/efectos de los fármacos , Zolpidem
7.
Paediatr Nurs ; 19(2): 14-8, 2007 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-17425124

RESUMEN

AIM: This article describes the current magnetic resonance imaging (MRI) sedation service, the role of the nurse sedationist, results of clinical audits, and future issues within MRI. METHOD: Data from 2004 until 2006 were analysed to describe the percentage of children who were successfully sedated, and any complications. The recovery profile was investigated by a questionnaire of 100 consecutive cases. FINDINGS: Sedation was attempted in 455 cases with chloral hydrate, and 325 with temazepam and droperidol. The success rate was 97.4 and 92.6 per cent respectively. Top-up sedation was used in 10 and 29 per cent respectively. There were seven minor incidents but none required admission. Approximately 20 per cent of children were drowsy the following day. CONCLUSION: We believe that the success of the service depends upon three main factors: the deselection of children in whom sedation is unsafe or likely to be unsuccessful, the use of appropriate drugs in limited doses, and the training of experienced nurses.


Asunto(s)
Sedación Consciente/enfermería , Imagen por Resonancia Magnética/enfermería , Rol de la Enfermera , Enfermería Pediátrica/organización & administración , Adyuvantes Anestésicos/uso terapéutico , Niño , Hidrato de Cloral/uso terapéutico , Protocolos Clínicos , Sedación Consciente/efectos adversos , Sedación Consciente/métodos , Droperidol/uso terapéutico , Monitoreo de Drogas/enfermería , Quimioterapia Combinada , Educación Continua en Enfermería , Humanos , Hipnóticos y Sedantes/uso terapéutico , Capacitación en Servicio , Liderazgo , Londres , Evaluación en Enfermería , Auditoría de Enfermería , Investigación en Evaluación de Enfermería , Alta del Paciente , Enfermería Pediátrica/educación , Autonomía Profesional , Seguridad , Temazepam/uso terapéutico
8.
BMC Fam Pract ; 7: 54, 2006 Sep 19.
Artículo en Inglés | MEDLINE | ID: mdl-16984636

RESUMEN

BACKGROUND: Double-blind randomised N-of-1 trials (N-of-1 trials) may help with decisions concerning treatment when there is doubt regarding the effectiveness and suitability of medication for individual patients. The patient is his or her own control, and receives the experimental and the control treatment during several periods of time in random order. Reports of N-of-1 trials are still relatively scarce, and the research methodology is not as firmly established as that of RCTs. Recently, we have conducted two series of N-of-1 trials in general practice. Before, during, and after data-collection, difficulties regarding outcome assessment, analysis of the results, the withdrawal of patients, and the follow-up had to be dealt with. These difficulties are described and our solutions are discussed. DISCUSSION: To prevent or anticipate difficulties in N-of-1 trials, we argue that that it is important to individualize the outcome measures, and to carefully consider the objective, type of randomisation and the analysis. It is recommended to use the same dosages and dosage forms that the patient used before the trial, to start the trial with a run-in period, to formulate both general and individualized decision rules regarding the efficacy of treatment, to adjust treatment policies immediately after the trial, and to provide adequate instructions and support if treatment is adjusted. SUMMARY: Because of the specific characteristics of N-of-1 trials it is difficult to formulate general 'how to do it' guidelines for designing N-of-1 trials. However, when the design of each N-of-1 trial is tailored to the specific characteristics of each individual patient and the underlying medical problem, most difficulties in N-of-1 trials can be prevented or overcome. In this way, N-of-1 trials may be of help when deciding on drug treatment for individual patients.


Asunto(s)
Medicina Familiar y Comunitaria/métodos , Ensayos Clínicos Controlados Aleatorios como Asunto/métodos , Resultado del Tratamiento , Acetaminofén/uso terapéutico , Analgésicos no Narcóticos/uso terapéutico , Antiinflamatorios no Esteroideos/uso terapéutico , Relación Dosis-Respuesta a Droga , Método Doble Ciego , Humanos , Hipnóticos y Sedantes/uso terapéutico , Osteoartritis/tratamiento farmacológico , Participación del Paciente , Selección de Paciente , Trastornos del Sueño-Vigilia/tratamiento farmacológico , Encuestas y Cuestionarios , Temazepam/uso terapéutico
9.
Curr Med Res Opin ; 21(2): 223-30, 2005 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-15801993

RESUMEN

OBJECTIVE: To compare the effects of temazepam 7.5 mg and temazepam 15 mg on sleep maintenance during the last third of the night (last 160 min) and on sleep architecture throughout the night. RESEARCH DESIGN AND METHODS: This was a retrospective analysis of a previously reported double-blind, randomized, uncontrolled, parallel-group, multicenter study. Healthy subjects with previous but no current complaints of transient insomnia were enrolled. Transient insomnia was induced in the sleep laboratory by means of the 'first night' effect and by implementing a 2-h phase advance. The effects of both doses of temazepam on polysomnographic measures of sleep were evaluated for 1 night. The primary, prospectively-defined analysis of this study showed that 7.5-mg and 15-mg doses of temazepam had equivalent effects on latency to persistent sleep, total sleep time, and the number of sleep interruptions recorded over an 8-h period. Both doses were well tolerated. The post hoc analysis reported here compared these 2 doses for their effects on sleep maintenance and architecture. Sleep efficiency during the last third of the night was designated as the primary endpoint. The methodology for this analysis was fully defined and documented prior to re-analysis of the database for these parameters. RESULTS: Sixty-five subjects received temazepam 7.5 mg and 66 received temazepam 15 mg. No statistically significant differences between doses were detected for sleep efficiency or number of sleep interruptions during the last third of the night. Sleep architecture (measured over 8 h) did not differ significantly between groups. CONCLUSIONS: The 7.5-mg and 15-mg doses of temazepam were equally effective for maintaining sleep during the last third of the night. Continuity of sleep throughout the night, as reflected by sleep architecture, was also similar regardless of dose. In keeping with current practice guidelines, initiation of treatment with temazepam for transient insomnia should begin with the 7.5 mg dose.


Asunto(s)
Ansiolíticos/administración & dosificación , Trastornos del Inicio y del Mantenimiento del Sueño/tratamiento farmacológico , Sueño/efectos de los fármacos , Temazepam/administración & dosificación , Adulto , Anciano , Ansiolíticos/efectos adversos , Ansiolíticos/uso terapéutico , Biomarcadores , Método Doble Ciego , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Multicéntricos como Asunto , Polisomnografía , Estudios Retrospectivos , Sueño/fisiología , Temazepam/efectos adversos , Temazepam/uso terapéutico , Factores de Tiempo , Resultado del Tratamiento
10.
Respir Med ; 99(2): 220-6, 2005 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-15715190

RESUMEN

INTRODUCTION: Older patients are the most prevalent age cohort requiring bronchoscopy. Prior sedation should be offered to improve patient comfort and operator technical ease. Older patients have increased sensitivity to centrally acting drugs increasing the procedural risk. This perceived risk may limit access to bronchoscopy in older patients. There have been no systematic prospective placebo-controlled studies in older patients. We compared a novel premedication regimen-oral temazepam plus nebulised Lignocaine (new treatment) to an established regimen of intravenous alfentanyl (control). METHODS: Consecutive patients 75 years and older referred for bronchoscopy were considered. Twenty-five patients were randomly assigned to each group. The primary outcome measure was the lowest oxygen saturation recorded from the administration of IV drugs and for 30 min post-bronchoscopy. RESULTS: The lowest mean oxygen saturation in the new treatment group was 92.2% (90.3-94.2) and in the control group 91.1% (89.2-93.1). This was not statistically different (P = 0.370). There were no adverse events. CONCLUSION: This is the largest prospective study to date on an older population undergoing bronchoscopy supporting previous retrospective findings regarding the safety of this procedure. Determined by oxygen saturations there is no difference in safety between premedication regimens comprising oral temazepam/nebulised lignocaine or intravenous alfentanyl.


Asunto(s)
Broncoscopía/métodos , Lidocaína/uso terapéutico , Enfermedades Pulmonares/diagnóstico , Dolor/prevención & control , Temazepam/uso terapéutico , Anciano , Anciano de 80 o más Años , Método Doble Ciego , Quimioterapia Combinada , Femenino , Humanos , Masculino , Satisfacción del Paciente , Premedicación/métodos , Estudios Prospectivos , Resultado del Tratamiento
11.
Aviat Space Environ Med ; 76(7 Suppl): C39-51, 2005 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-16018329

RESUMEN

Uncomfortable working and sleeping environments, high operational tempos, sustained operations, and insufficient staffing make fatigue a growing concern. In aviation, where a single mistake can cost millions of dollars, it is essential to optimize operator alertness. Although behavioral and administrative fatigue countermeasures should comprise the "first line" approach for sustaining aircrew performance, pharmacological fatigue countermeasures are often required. Various components of the U.S. military have authorized the use of specific compounds for this purpose. Hypnotics such as temazepam, zolpidem, or zaleplon can mitigate the fatigue associated with insufficient or disturbed sleep. Alertness-enhancing compounds such as caffeine, modafinil, or dextroamphetamine can temporarily bridge the gap between widely spaced sleep periods. Each of these medications has a role in sustaining the safety and effectiveness of military aircrews. The present paper provides a short overview of these compounds as well as factors to be considered before choosing one or more to help manage fatigue.


Asunto(s)
Medicina Aeroespacial , Fatiga/prevención & control , Medicina Militar , Acetamidas/farmacología , Acetamidas/uso terapéutico , Ansiolíticos/farmacología , Ansiolíticos/uso terapéutico , Compuestos de Bencidrilo/farmacología , Compuestos de Bencidrilo/uso terapéutico , Ritmo Circadiano/efectos de los fármacos , Humanos , Hipnóticos y Sedantes/farmacología , Hipnóticos y Sedantes/uso terapéutico , Modafinilo , Piridinas/farmacología , Piridinas/uso terapéutico , Pirimidinas/farmacología , Pirimidinas/uso terapéutico , Sueño/efectos de los fármacos , Temazepam/farmacología , Temazepam/uso terapéutico , Estados Unidos , Zolpidem
12.
Clin Pharmacol Ther ; 39(3): 345-52, 1986 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-2868823

RESUMEN

Two benzodiazepine hypnotics, one with an intermediate elimination t1/2 (temazepam, 15 mg) and the other with a long t1/2 (quazepam, 15 mg), were evaluated in 22- night sleep laboratory studies. The effectiveness and side effects of these benzodiazepines were assessed during short- and intermediate term use. Subjects were also assessed for the presence of rebound insomnia after abrupt withdrawal. Quazepam, 15 mg, was significantly effective in improving sleep both with short- and intermediate-term use, but the effectiveness of temazepam was considerably less. Although temazepam was effective for maintaining sleep with short-term use, there was rapid development of tolerance for this effect with intermediate-term use. Temazepam did not produce any behavioral side effects during either drug condition. The only side effect associated with quazepam was a significant degree of daytime sleepiness. After its withdrawal, temazepam was associated with some sleep and mood disturbance on the first withdrawal night, whereas quazepam had carryover effectiveness.


Asunto(s)
Ansiolíticos/uso terapéutico , Benzodiazepinas/uso terapéutico , Trastornos del Inicio y del Mantenimiento del Sueño/tratamiento farmacológico , Síndrome de Abstinencia a Sustancias , Temazepam/uso terapéutico , Adulto , Anciano , Benzodiazepinas/efectos adversos , Benzodiazepinas/metabolismo , Ensayos Clínicos como Asunto , Evaluación de Medicamentos , Semivida , Humanos , Cinética , Persona de Mediana Edad , Distribución Aleatoria , Sueño/efectos de los fármacos , Temazepam/efectos adversos , Temazepam/metabolismo
13.
Clin Pharmacol Ther ; 62(4): 444-52, 1997 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-9357396

RESUMEN

BACKGROUND AND OBJECTIVE: Quantitative electroencephalographic parameters and saccadic eye movements are frequently used as pharmacodynamic measures of benzodiazepine effect. We investigated the relationship between these measures and the hypnotic effect. METHODS: The correlation between the pharmacodynamic measures and sleep quality was determined in 21 patients with primary insomnia. The pharmacokinetic-pharmacodynamic relationships were characterized after administration of 20 mg oral temazepam. The hypnotic effect was determined on the basis of polysomnographic sleep recordings and a subjective sleep evaluation questionnaire. Correlations between pharmacodynamic measures and the improvement of sleep were investigated. RESULTS: The pharmacokinetic-pharmacodynamic relationships for the parameters derived from electroencephalography and saccadic eye movements showed considerable interindividual variability. Administration of temazepam led to a significant improvement in the objective parameters sleep period efficiency, wake time after sleep onset, and sleep efficiency and in the subjective assessment of sleep quality. No significant correlations were observed between the pharmacokinetic-pharmacodynamic-derived parameters and the improvement in objective or subjective sleep parameters. CONCLUSION: In subjects with primary insomnia the administration of 20 mg oral temazepam results in changes in both the pharmacodynamic measures and in quality of sleep. No individual correlations between the pharmacodynamic measures and quality of sleep were observed. We concluded that the investigated pharmacodynamic measures are of value in the first assessment of clinical efficacy and for the selection of the dose(s) to be investigated in subsequent trials that aim at showing clinical efficacy. However, the conclusive quantification of clinical efficacy should be performed only on the basis of the clinical end point itself.


Asunto(s)
Ansiolíticos/farmacología , Electroencefalografía/efectos de los fármacos , Movimientos Sacádicos/efectos de los fármacos , Trastornos del Inicio y del Mantenimiento del Sueño/tratamiento farmacológico , Trastornos del Inicio y del Mantenimiento del Sueño/fisiopatología , Sueño/efectos de los fármacos , Temazepam/farmacología , Adulto , Anciano , Ansiolíticos/uso terapéutico , Femenino , Humanos , Masculino , Persona de Mediana Edad , Polisomnografía , Valor Predictivo de las Pruebas , Trastornos del Inicio y del Mantenimiento del Sueño/sangre , Encuestas y Cuestionarios , Temazepam/uso terapéutico , Resultado del Tratamiento
14.
Clin Pharmacol Ther ; 68(2): 175-88, 2000 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-10976549

RESUMEN

BACKGROUND: A hypnogram shows how sleep travels through its various stages in the course of a night. The sleep stage changes can be quantified to study sedative drug effects. METHODS: Hypnograms from 21 patients with primary insomnia were collected during a randomized, placebo-controlled crossover study of 20 mg temazepam. A separate daytime session was performed to determine the pharmacokinetics of 20 mg temazepam and its effect on saccadic eye movement and electroencephalogram. A first-order Markov model was developed to describe the probability of sleep stage changes as a function of time after drug intake and time after last sleep stage change. The influence of temazepam concentration on the probability to change sleep stage was incorporated into the model. RESULTS: Transitions between sleep stages were profoundly influenced by the time of the night and by the time since the last change of sleep stage. Temazepam reduced the time spent awake. This effect could be attributed to four mechanisms: (1) transition to "deeper" sleep was facilitated, (2) transition to "lighter" sleep was inhibited, (3) regardless of sleep stage, the transition to wake state was inhibited, and (4) return to sleep was facilitated. Daytime sensitivities to temazepam, measured with the surrogate markers saccadic peak velocity and electroencephalogram beta activity, each correlated with one of the transition probabilities influenced by temazepam. CONCLUSIONS: By the development of a Markov model for these non-ordered six categorical data, the effect of temazepam on the sleep-wake status could be interpreted in terms of known mechanisms for sleep generation and benzodiazepine pharmacology.


Asunto(s)
Sueño/efectos de los fármacos , Temazepam/farmacología , Adolescente , Adulto , Anciano , Ansiolíticos/farmacología , Ansiolíticos/uso terapéutico , Estudios Cruzados , Femenino , Humanos , Masculino , Cadenas de Markov , Persona de Mediana Edad , Modelos Biológicos , Polisomnografía , Trastornos del Inicio y del Mantenimiento del Sueño/tratamiento farmacológico , Fases del Sueño/efectos de los fármacos , Estadística como Asunto , Temazepam/uso terapéutico , Factores de Tiempo
15.
Drugs ; 21(5): 321-40, 1981 May.
Artículo en Inglés | MEDLINE | ID: mdl-6112127

RESUMEN

Temazepam is a benzodiazepine drug which is a minor metabolite of diazepam. In clinical studies using subjective evaluation methods it was effective for maintaining sleep and increasing total sleep time. However, sleep laboratory studies did not show a significant effect on some sleep parameters, especially sleep induction. Temazepam has a relatively short half-life (about 5 to 11 hours, longer in some subjects and in the elderly), and no active metabolites of clinical importance, and thus may be considered more suitable for use as an hypnotic than longer acting drugs such as diazepam, nitrazepam or flurazepam when residual sedative effects the next day are not desirable. Indeed, few residual effects on morning performance appear to occur with usual single doses of temazepam, although at the upper end of the recommended dosage range (30 mg or more) some evidence of impaired psychomoter and cognitive function in the morning has been reported. Whether or not temazepam is likely to produce "hangover" with repeated night-time administration needs further clarification. While a call for a large number of controlled trials may not be justifiable in evaluating a new hypnotic, a few well designed additional comparative studies in insomniac subjects are needed to assess adequately the relative merits of temazepam (particularly with regard to sleep onset) compared with other benzodiazepine hypnotics, especially those which are short- or intermediate-acting.


Asunto(s)
Ansiolíticos/farmacología , Hipnóticos y Sedantes , Temazepam/farmacología , Animales , Humanos , Cinética , Temazepam/metabolismo , Temazepam/uso terapéutico
16.
Sleep ; 18(8): 644-5, 1995 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-8560129

RESUMEN

This study evaluated the respiratory effect of temazepam in elderly subjects (mean age 65 +/- 3.8 years), with mild sleep apnea. The 15 subjects of this report were enrolled in a larger randomized trial comparing pharmacological and behavioral treatments for insomnia. Seven subjects received temazepam 15-30 mg/day either alone or in combination with behavior therapy, and eight subjects received placebo or behavior therapy. The mean baseline respiratory disturbance index (RDI) was 9.2 +/- 2.8 for the nondrug and 8.8 +/- 5.3 for the temazepam group. There were no significant time, group or interaction effects. There was no increase in the RDI in elderly subjects with mild respiratory apnea receiving 15-30 mg of temazepam.


Asunto(s)
Anciano , Hipnóticos y Sedantes/farmacología , Hipnóticos y Sedantes/uso terapéutico , Respiración/efectos de los fármacos , Síndromes de la Apnea del Sueño/tratamiento farmacológico , Temazepam/farmacología , Humanos , Persona de Mediana Edad , Temazepam/administración & dosificación , Temazepam/uso terapéutico
17.
Sleep ; 9(3): 385-92, 1986.
Artículo en Inglés | MEDLINE | ID: mdl-2876485

RESUMEN

Clonazepam (1 mg h.s.) and temazepam (30 mg h.s.) were studied in 10 patients diagnosed as having insomnia with nocturnal myoclonus. Each subject underwent two nocturnal polysomnographic recordings while drug-free, two during treatment with clonazepam, and two during treatment with temazepam. Treatment sessions were 7 days long, and recordings were done on nights 6 and 7 of the treatment sessions. A 14-day washout period separated the treatment sessions. The order of drugs used in the first and second treatment sessions was randomized. Objective and subjective sleep laboratory data showed that both drugs improved the sleep of patients with insomnia in association with nocturnal myoclonus. Neither drug significantly reduced the number of nocturnal myoclonic events. Sleep changes were consistent with those produced by sedative benzodiazepines in general. Thus, the data support clinical reports that clonazepam, a benzodiazepine marketed for the indication of seizure, is useful in improving sleep disturbances associated with nocturnal myoclonus. Temazepam, a benzodiazepine marketed for the indication of insomnia, was found to be a suitable alternative to clonazepam in the treatment of insomnia associated with nocturnal myoclonus. The present data and other studies suggest the need for a model that explains why leg movements and sleep disturbances may wax and wane independently.


Asunto(s)
Ansiolíticos/uso terapéutico , Clonazepam/uso terapéutico , Mioclonía/tratamiento farmacológico , Síndrome de las Piernas Inquietas/tratamiento farmacológico , Trastornos del Inicio y del Mantenimiento del Sueño/tratamiento farmacológico , Temazepam/uso terapéutico , Adulto , Ensayos Clínicos como Asunto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Mioclonía/complicaciones , Distribución Aleatoria , Síndrome de las Piernas Inquietas/complicaciones , Trastornos del Inicio y del Mantenimiento del Sueño/etiología
18.
Sleep ; 16(6): 529-38, 1993 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-8235237

RESUMEN

We studied seven male patients with moderate to severe congestive heart failure (CHF) [left ventricular ejection fraction (LVEF) = 22.4 +/- 6.7; mean +/- SD] in a double-blind crossover trial to determine the effects of temazepam 15 mg on arousability, sleep architecture, Cheyne-Stokes respiration (CSR) and nighttime oxygen saturation. Sleep architecture was not markedly improved with temazepam. There was no significant change in total sleep time (TST) (383.1 +/- 14.1 minutes to 396.6 +/- 15.4 minutes, p = ns) (mean +/- SE, placebo vs. temazepam) or total wake time (TWT) (96.9 +/- 14.0 vs. 81.4 +/- 14.0 minutes, p = ns). Sleep stage proportions did not change appreciably except for a reduction in stage 1 sleep (6.7 +/- 1.2% vs. 4.0 +/- 1.0%, p < 0.05). Microarousals per hour of sleep decreased with temazepam (21.1 +/- 2.7/hour vs. 13.9 +/- 2.1/hour placebo, p < 0.05), with the largest change occurring in stage 2 (24.9 +/- 5.4/hour vs. 15.0 +/- 3.1/hour, p < 0.05). Wake time during sleep (WDS) was reduced from 82.5 +/- 11.7 minutes to 54.5 +/- 9.4 minutes, p < 0.03. Daytime alertness was improved with temazepam as was indicated by an increase in mean latency to sleep [multiple sleep latency test (MSLT) = 7.1 +/- 2.4 vs. 5.7 +/- 2.0 minutes, p < 0.04) on days following treatment with temazepam. There was no significant change in CSR as a percentage of TST (38.7 +/- 13.6% vs. 32.5 +/- 11.8%, p = ns). However, the apnea/hypopnea index (AHI) (10% filter) was decreased in stage 1 (28.1 +/- 9.7/hour vs. 15.6 +/- 8.2/hour). Overnight oxygen saturation did not change with temazepam (95.1 +/- 0.6% both nights) and the percentage of TST spent below 90% oxygen saturation was minimal for both conditions (1.5 +/- 1.1% vs. 2.2 +/- 1.7%, p = ns). We conclude that CHF patients with CSR experience frequent arousals and that these arousals can be reduced with temazepam. There was an improvement in daytime somnolence. There was no worsening of nighttime oxygen saturation.


Asunto(s)
Nivel de Alerta/efectos de los fármacos , Benzodiazepinas/farmacología , Respiración de Cheyne-Stokes/tratamiento farmacológico , Insuficiencia Cardíaca/tratamiento farmacológico , Temazepam/farmacología , Anciano , Benzodiazepinas/uso terapéutico , Encéfalo/efectos de los fármacos , Respiración de Cheyne-Stokes/etiología , Respiración de Cheyne-Stokes/fisiopatología , Electroencefalografía , Insuficiencia Cardíaca/complicaciones , Insuficiencia Cardíaca/fisiopatología , Humanos , Masculino , Persona de Mediana Edad , Polisomnografía , Pruebas de Función Respiratoria , Fases del Sueño , Trastornos del Sueño-Vigilia/diagnóstico , Sueño REM , Temazepam/uso terapéutico
19.
J Clin Psychiatry ; 44(2): 47-53, 1983 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-6826530

RESUMEN

Insomnia--the chronic inability to obtain the amount and quality of sleep needed for effective daytime function--is a common subjective complaint. Several major causes exist, and many strategems can be used in management. When drugs are indicated, the benzodiazepines are the first choice. Flurazepam, a long-acting compound, has recently been complemented by temazepam, a shorter-acting hypnotic. The pharmacokinetics, actions, and clinical uses of temazepam are reviewed. It is concluded that temazepam is preferable where daytime alertness must be unimpaired, with flurazepam reserved for patients who need daytime sedation.


Asunto(s)
Benzodiazepinas/uso terapéutico , Hipnóticos y Sedantes/uso terapéutico , Trastornos del Inicio y del Mantenimiento del Sueño/tratamiento farmacológico , Benzodiazepinas/metabolismo , Fenómenos Químicos , Química , Humanos , Cinética , Sueño/efectos de los fármacos , Trastornos del Inicio y del Mantenimiento del Sueño/etiología , Temazepam/farmacología , Temazepam/uso terapéutico
20.
J Clin Psychiatry ; 52 Suppl: 16-23, 1991 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-2071567

RESUMEN

Findings from a four-city study of the beneficial and adverse effects of hypnotics are reported. The study employed a new volunteer call-in method for monitoring drug effects outside of the clinical setting. Respondents were recruited through newspaper advertisements. They were invited to complete a short telephone interview if, during the past 12 months, they (1) had significant trouble with insomnia or (2) had taken a medication to induce sleep. Comparison groups were flurazepam, temazepam, triazolam, and over-the-counter (OTC) sleep medications. An untreated insomnia group also was included. Results indicate that most users of prescription hypnotics attributed positive effects to their sleep medications and that adverse effects were infrequent. OTC hypnotics were less effective and more likely to produce negative effects. The untreated insomnia group was more symptomatic than any of the medication groups.


Asunto(s)
Benzodiazepinas/uso terapéutico , Hipnóticos y Sedantes/uso terapéutico , Trastornos del Inicio y del Mantenimiento del Sueño/tratamiento farmacológico , Adolescente , Adulto , Anciano , Actitud Frente a la Salud , Benzodiazepinas/efectos adversos , Recolección de Datos , Prescripciones de Medicamentos/normas , Estudios de Evaluación como Asunto , Femenino , Flurazepam/efectos adversos , Flurazepam/uso terapéutico , Humanos , Hipnóticos y Sedantes/efectos adversos , Masculino , Persona de Mediana Edad , Medicamentos sin Prescripción/efectos adversos , Medicamentos sin Prescripción/normas , Trastornos del Inicio y del Mantenimiento del Sueño/psicología , Teléfono , Temazepam/efectos adversos , Temazepam/uso terapéutico , Triazolam/efectos adversos , Triazolam/uso terapéutico
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