Abstract:
OBJECTIVES:To evaluate the efficacy and safety profile of gaboxadol, a selective extrasynaptic GABA(A) agonist (SEGA) previously in development for the treatment of insomnia. METHODS:This was a randomised, double-blind, placebo-controlled, parallel-group, 2-week, Phase III study of gaboxadol 5, 10 and 15mg in outpatients meeting the DSM-IV criteria of primary insomnia (N=742). Zolpidem 10mg was used as active reference. RESULTS:At weeks 1 and 2, significant improvement in total sleep time (sTST) compared to placebo was seen for all doses of gaboxadol (all p<0.05). In addition, gaboxadol 10 and 15mg decreased the number of awakenings (sNAW) (p<0.05) while only gaboxadol 15mg improved wakefulness after sleep onset (sWASO) (p<0.05). At week 1, all doses of gaboxadol significantly improved time-to-sleep onset (sTSO) (p<0.05). At week 2, a sustained effect on sTSO was observed for gaboxadol 15mg. Zolpidem also showed effect on all of these variables. Gaboxadol and zolpidem improved sleep quality, freshness after sleep, daytime function and energy at both weeks. Transient rebound insomnia was observed following discontinuation of treatment with zolpidem, but not gaboxadol. CONCLUSIONS:Gaboxadol 15mg treatment for 2 weeks significantly improved sleep onset and maintenance variables as well as sleep quality and daytime function, as did zolpidem. Gaboxadol 5 and 10mg also showed benefits on most efficacy variables. Gaboxadol was generally safe and well tolerated, with no evidence of withdrawal symptoms or rebound insomnia after discontinuation of short-term treatment. For zolpidem, transient rebound insomnia was observed.
journal_name
Sleep Medjournal_title
Sleep medicineauthors
Hajak G,Hedner J,Eglin M,Loft H,Stórustovu SI,Lütolf S,Lundahl J,Gaboxadol Study 99775 Group.doi
10.1016/j.sleep.2008.09.010subject
Has Abstractpub_date
2009-08-01 00:00:00pages
705-12issue
7eissn
1389-9457issn
1878-5506pii
S1389-9457(08)00309-2journal_volume
10pub_type
杂志文章,随机对照试验相关文献
SLEEP MEDICINE文献大全abstract::Angelman syndrome is a neurogenetic condition characterized by developmental delay, absence of speech, motor impairment, epilepsy and a peculiar behavioral phenotype that includes sleep problems. It is caused by lack of expression of the UBE3A gene on the maternal chromosome 15q11-q13. Although part of the diagnostic ...
journal_title:Sleep medicine
pub_type: 杂志文章
doi:10.1016/j.sleep.2007.07.001
更新日期:2008-05-01 00:00:00
abstract:INTRODUCTION:Sleep apnea-hypopnea syndrome (SAHS) is an emerging disease with high prevalence. There is controversy as to whether cardiac abnormalities are due to the disease itself or to the arterial hypertension frequently associated with this disease. OBJECTIVES:To analyze echocardiographic abnormalities in a popul...
journal_title:Sleep medicine
pub_type: 临床试验,杂志文章
doi:10.1016/j.sleep.2008.03.008
更新日期:2009-03-01 00:00:00
abstract:AIM:The aim of this study is to assess the effect of switching to rotigotine transdermal patch on severity of restless legs syndrome (RLS) in patients who experienced acute augmentation with previous oral dopaminergics. METHODS:In this 13-month observational study, adults with moderate-to-severe RLS and augmentation w...
journal_title:Sleep medicine
pub_type: 杂志文章
doi:10.1016/j.sleep.2015.10.006
更新日期:2017-02-01 00:00:00
abstract:BACKGROUND:Type 1 narcolepsy (NT1) is a central hypersomnia linked to the destruction of hypocretin-producing neurons. A great body of genetic and epidemiological data points to likely autoimmune disease aetiology. Recent reports have characterized peripheral blood T-cell subsets in NT1, whereas data regarding the cere...
journal_title:Sleep medicine
pub_type: 杂志文章
doi:10.1016/j.sleep.2017.11.1150
更新日期:2018-04-01 00:00:00
abstract:OBJECTIVE:This study aimed to cast light on the relationships between sleep habits, perceived sleep problems and school performance in Evening-type (E-type) compared with Morning-type (M-type) early adolescents. METHODS:Comparison of questionnaire data of E-type and M-type adolescents random-selected from a large samp...
journal_title:Sleep medicine
pub_type: 杂志文章
doi:10.1016/j.sleep.2016.09.019
更新日期:2017-01-01 00:00:00
abstract:BACKGROUND:The status of night-to-night variability for periodic limb movements in sleep (PLMS) has not been clarified. With this in mind, we investigated the validity of PLMS measurement by actigraphy with the PAM-RL device in Japanese patients with suspected restless legs syndrome (RLS) or periodic limb movement diso...
journal_title:Sleep medicine
pub_type: 临床试验,杂志文章
doi:10.1016/j.sleep.2013.08.790
更新日期:2014-01-01 00:00:00
abstract:OBJECTIVE:The purpose of this study was to explore the effects of a 24-week Tai Ji Quan training program on sleep quality, quality of life, and physical performance among elderly Chinese women with knee osteoarthritis (OA). METHODS:A 24-week randomized, controlled trial of 46 elderly women with knee OA. Participants w...
journal_title:Sleep medicine
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.sleep.2016.12.024
更新日期:2017-05-01 00:00:00
abstract:BACKGROUND AND PURPOSES:To report the neurophysiological features of a patient with alternating leg muscle activation (ALMA) during sleep, a quickly alternating pattern of anterior tibialis activation which might represent transient facilitation of a spinal central pattern generator for locomotion, perhaps due to the s...
journal_title:Sleep medicine
pub_type: 杂志文章
doi:10.1016/j.sleep.2005.06.007
更新日期:2006-01-01 00:00:00
abstract:BACKGROUND:We examined the relationship between baseline substantia nigra (SN) echogenicity on transcranial sonography (TCS) images and medium-to long-term developments of Parkinson's disease (PD) and dementia with Lewy bodies (DLB) in idiopathic RBD (IRBD) patients. METHODS:From 2007-2009, TCS and odor identification...
journal_title:Sleep medicine
pub_type: 杂志文章
doi:10.1016/j.sleep.2019.09.008
更新日期:2020-04-01 00:00:00
abstract:OBJECTIVE:An association between migraine and sleep disturbances in children was reported, yet limited clinical data exist. The current study addresses the clinical presentation, polysomnographic (PSG) characteristics, and comorbid sleep diagnoses of children with migraine referred to the sleep clinic. PATIENTS:A retr...
journal_title:Sleep medicine
pub_type: 杂志文章
doi:10.1016/j.sleep.2019.04.023
更新日期:2019-11-01 00:00:00
abstract:OBJECTIVE:Later school start times for adolescents have been implemented in the US and associated benefits found, although no randomised controlled trials (RCT) have been undertaken. The objective of this study was to evaluate the impact of two school interventions in the UK, a delayed start time and a sleep education ...
journal_title:Sleep medicine
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.sleep.2018.10.021
更新日期:2019-08-01 00:00:00
abstract:BACKGROUND AND PURPOSE:The aim of this study was to investigate the demographic variables and clinical characteristics of behaviorally induced insufficient sleep syndrome (BIISS) and to compare it with the other major hypersomnia disorders. PATIENTS AND METHODS:One-thousand two-hundred forty-three consecutive patients...
journal_title:Sleep medicine
pub_type: 杂志文章
doi:10.1016/j.sleep.2007.08.018
更新日期:2008-12-01 00:00:00
abstract:BACKGROUND:Impaired sleep efficiency is independently associated with worse prognosis in patients with chronic heart failure (CHF). Therefore, a test was conducted on whether auto-servo ventilation (ASV, biphasic positive airway pressure [BiPAP]-ASV, Philips Respironics) reduces sleep fragmentation and improves sleep e...
journal_title:Sleep medicine
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.sleep.2015.08.020
更新日期:2016-01-01 00:00:00
abstract:OBJECTIVES:In some patients with obstructive sleep apnea (OSA), Epworth Sleepiness Scale scores (ESS) do not reflect the severity of disease. In many cases, bed partners (BPs) report more severe hypersomnia on the part of the patient than the patient him/herself. The purpose of this study was to assess the agreement be...
journal_title:Sleep medicine
pub_type: 杂志文章
doi:10.1016/s1389-9457(01)00079-x
更新日期:2002-01-01 00:00:00
abstract:INTRODUCTION:Patients with implantable cardioverter defibrillators (ICDs) frequently experience sleep disruption. Prior work shows associations between objective (actigraphic) sleep and cognition in these patients, but whether pain affects associations between measures of sleep fragmentation (eg, sleep efficiency, SE) ...
journal_title:Sleep medicine
pub_type: 杂志文章
doi:10.1016/j.sleep.2020.03.029
更新日期:2020-08-01 00:00:00
abstract:BACKGROUND:Sleep quality affects all aspects of daily functioning, and it is vital for facilitating recovery from illness and injury. Sleep commonly becomes disrupted following moderate to severe brain injury, yet little is known about the prevalence of sleep disruption over time and how it impacts on recovery followin...
journal_title:Sleep medicine
pub_type: 杂志文章
doi:10.1016/j.sleep.2015.04.013
更新日期:2015-08-01 00:00:00
abstract::Objective: (i) Evaluation of the clinical differences and similarities presented by patients diagnosed as OSAS and UARS subjects. (ii) Evaluation of the ability of a sleep disorders specialist to dissociate the two syndromes based upon clinical evaluation.Population: 314 subjects were included. They were referred to a...
journal_title:Sleep medicine
pub_type: 杂志文章
doi:10.1016/s1389-9457(99)00011-8
更新日期:2000-02-01 00:00:00
abstract:OBJECTIVES:The effects of antiepileptic drugs (AEDs) on sleep architecture are not well understood, especially in patients with localization-related epilepsy, in whom seizures themselves can disrupt sleep. To clarify the effects of AEDs on sleep architecture, we performed a prospective study, looking at sleep architect...
journal_title:Sleep medicine
pub_type: 杂志文章
doi:10.1016/s1389-9457(02)00217-4
更新日期:2003-01-01 00:00:00
abstract:OBJECTIVES:To test agreement and define differences in periodic limb movements in sleep (PLMS) measured by polysomnography and an ankle activity monitor, and to describe PLMS variability across nights, feasibility of home monitoring, and correlates of PLMS in children with sickle cell disease (SCD). METHODS:Twenty chi...
journal_title:Sleep medicine
pub_type: 临床试验,杂志文章
doi:10.1016/j.sleep.2012.06.016
更新日期:2012-09-01 00:00:00
abstract:OBJECTIVES:Pediatric obesity and sleep-disordered breathing (SDB) are strongly associated, and both promote metabolic impairments. However, the effects of a lifestyle intervention on the overall metabolic syndrome (MetS) are unknown. The objectives were i) to evaluate the effects of a lifestyle intervention on cardiome...
journal_title:Sleep medicine
pub_type: 杂志文章
doi:10.1016/j.sleep.2020.06.030
更新日期:2020-11-01 00:00:00
abstract:BACKGROUND:Repetitive transcranial magnetic stimulation (rTMS) has been considered a promising technique for the treatment of primary insomnia. However, its efficacy and placebo response remains unclear due to limited clinical data. Therefore, we conducted a systematic review to examine the efficacy and placebo respons...
journal_title:Sleep medicine
pub_type: 杂志文章,meta分析
doi:10.1016/j.sleep.2019.05.008
更新日期:2019-11-01 00:00:00
abstract:BACKGROUND:While continuous positive airway pressure (CPAP) effectively treats obstructive sleep apnea (OSA), adherence to CPAP is suboptimal. The short-term efficacy of and adherence with a convenient expiratory positive airway pressure (EPAP) nasal device was evaluated in OSA patients non-adherent with CPAP. METHODS...
journal_title:Sleep medicine
pub_type: 临床试验,杂志文章
doi:10.1016/j.sleep.2010.06.011
更新日期:2011-02-01 00:00:00
abstract:OBJECTIVE:To examine the effect of nasal bilevel positive airway pressure (BiPAP) treatment for concurrent sleep-related breathing disorders (SRBDs) and attention-deficit hyperactivity disorder (ADHD) on electrophysiological measures of spontaneous brain activity and auditory stimulus processing. METHODS:Nineteen chil...
journal_title:Sleep medicine
pub_type: 杂志文章
doi:10.1016/s1389-9457(01)00121-6
更新日期:2001-09-01 00:00:00
abstract:OBJECTIVES:The present study investigated the effectiveness of a school-based sleep education programme in improving key sleep behaviours, sleep knowledge, and sleep hygiene. DESIGN AND METHODS:A cross-sectional cluster-randomised controlled trial with two groups (Intervention and Control) and three assessment time po...
journal_title:Sleep medicine
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.sleep.2015.02.534
更新日期:2015-06-01 00:00:00
abstract:BACKGROUND:Childhood sleep habits are associated with mental health development; however, little is known about the impact of irregular bedtimes on the mental health of early school-aged children. The aims of this study were to examine the effect of weekday sleep habits (varying bedtimes depending on the night of the w...
journal_title:Sleep medicine
pub_type: 杂志文章
doi:10.1016/j.sleep.2017.12.015
更新日期:2018-05-01 00:00:00
abstract:OBJECTIVE:The aim of this study was to analyze statistically the number of single leg movements (LMs) forming bilateral LMs during sleep, along with their combined duration, to eventually provide evidence-based data for the adjustment of the current scoring rules defining bilateral LMs. METHODS:Polysomnographic record...
journal_title:Sleep medicine
pub_type: 杂志文章
doi:10.1016/j.sleep.2016.03.018
更新日期:2017-04-01 00:00:00
abstract:BACKGROUND:Narcolepsy is often not recognized or accurately diagnosed. This may be due to the fact that cataplexy, a core symptom which is virtually 100% specific, can-in practice-only be diagnosed based on the patient's history. However, the current definition of cataplexy is not very precise and the common distinctio...
journal_title:Sleep medicine
pub_type: 杂志文章
doi:10.1016/j.sleep.2010.05.010
更新日期:2011-01-01 00:00:00
abstract:BACKGROUND:Restless legs syndrome (RLS) is a frequent neurological disorder which is presented in idiopathic and secondary form. Idiopathic RLS is associated with common genetic variants in four chromosomal regions. Recently, multiple sclerosis (MS) was identified as a common cause for secondary RLS. The aim of our stu...
journal_title:Sleep medicine
pub_type: 杂志文章
doi:10.1016/j.sleep.2012.03.012
更新日期:2012-08-01 00:00:00
abstract::Most secondary forms of REM sleep behavior disorder are associated with neurodegenerative diseases belonging to the α-synucleinopathies or with narcolepsy. However, RBD may also occur in subacute- or acute-onset conditions involving the central nervous system, irrespective of subjects' age and sex, and with or without...
journal_title:Sleep medicine
pub_type: 杂志文章,评审
doi:10.1016/j.sleep.2011.10.011
更新日期:2011-12-01 00:00:00
abstract:BACKGROUND AND PURPOSE:The pressures generated within the upper esophageal sphincter (P(UES)) and lower esophageal sphincter (P(LES)) reflect the integrity of these barriers to gastroesophageal and pharyngoesophageal reflux, respectively. This study sought to describe the effects of sleep, respiration and posture on th...
journal_title:Sleep medicine
pub_type: 杂志文章
doi:10.1016/j.sleep.2006.08.016
更新日期:2007-03-01 00:00:00