Trial reportSleep2008
Effect of gaboxadol on sleep in adult and elderly patients with primary insomnia: results from two randomized, placebo-controlled, 30-night polysomnography studies.
Trial report in Sleep, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 15 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Double-Blind, Randomized, Placebo-Controlled, Multicenter, 30-Night Polysomnographic Study of MK0928 in Adult Patients With Primary Insomnia
A Double-Blind, Randomized, Placebo-Controlled, Multicenter, 30-Night Polysomnographic Study of MK0928 in Elderly Patients With Primary Insomnia
Who cites it
15 citing papers in PubMed, 1 synthesis or guideline pooled it, 43 citations in OpenAlex.
- Pooled it
- Trial
- EEG power spectra response to a 4-h phase advance and gaboxadol treatment in 822 men and women.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2011Trial
- The effect of vestibular stimulation in a four-hour sleep phase advance model of transient insomnia.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2010Trial
- Effect of gaboxadol on patient-reported measures of sleep and waking function in patients with Primary Insomnia: results from two randomized, controlled, 3-month studies.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2010Trial
- Hyperactivation of distinct thalamic nuclei differentially impairs sleep physiology in rats.Molecular psychiatry · 2026Article
- Reducing brain kynurenic acid synthesis precludes kynurenine-induced sleep disturbances.Journal of sleep research · 2024Article
- Altered Sleep Oscillations as Neurophysiological Biomarkers of Schizophrenia.Advances in neurobiology · 2024Review
- The Case for Clinical Trials with Novel GABAergic Drugs in Diabetes Mellitus and Obesity.Life (Basel, Switzerland) · 2022Article
- Evaluating the evidence for sex differences: a scoping review of human neuroimaging in psychopharmacology research.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2022Article
- Sleep as a Therapeutic Target in the Aging Brain.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2019Review
- Comparing the discriminative stimulus effects of modulators of GABAA receptors containing α4-δ subunits with those of gaboxadol in rats.Psychopharmacology · 2016Article
- Sensitivity and specificity of polysomnographic criteria for defining insomnia.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2013Article
- Reduced GABA(A) receptor-mediated tonic inhibition in aged rat auditory thalamus.The Journal of neuroscience : the official journal of the Society for Neuroscience · 2013Article
- Drug-related Sleep Stage Changes: Functional Significance and Clinical Relevance.Sleep medicine clinics · 2010Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
STUDY
objectivesTo evaluate the efficacy and tolerability of gaboxadol in the treatment of adult and elderly patients with primary insomnia.
designRandomized, double-blind, placebo-controlled, multicenter, 30-night, polysomnography studies.
settingSleep laboratory. PATIENTS: Primary insomnia, 18-64 y (adult study), or > or =65 y (elderly study).
interventionsAdult study: gaboxadol 15 mg (GBX15; N = 148), 10 mg (GBX10; N = 154), or placebo (N = 156); elderly study: GBX10 (N = 157), gaboxadol 5 mg (GBX5; N = 153), or placebo (N=176). MEASUREMENTS AND
resultsPrimary endpoints were wake after sleep onset (WASO) and latency to persistent sleep (LPS). Slow wave sleep (SWS) was a secondary endpoint. Analyses were based on the change from baseline for the average of nights 1/2, and nights 29/30, and compared gaboxadol versus placebo. Exploratory endpoints included patient's subjective assessment of total sleep time (sTST), WASO (sWASO), time to sleep onset (sTSO), and number of awakenings (sNAW); these analyses were based on weekly means. 1) Adult study. GBX15 significantly (P < or = 0.05) improved WASO through nights 29/30 but had no significant effects on LPS. No significant differences were seen for GBX10 versus placebo on WASO or LPS. GBX15 and GBX10 enhanced SWS. GBX15 significantly improved sTST, sWASO, sTSO, and sNAW at weeks 1 and 4. 2) Elderly study. GBX10 significantly improved WASO through nights 29/30; a significant improvement was also seen for GBX5 at nights 1/2 but this was not maintained through nights 29/30. GBX10 significantly improved LPS at nights 1/2 but the improvement was not maintained through nights 29/30; no significant differences were seen for GBX5 versus placebo on LPS. GBX10 and GBX5 enhanced SWS. GBX10 significantly improved sTST at week 1, and sTST, sWASO, and sNAW at week 4. Gaboxadol was generally well tolerated in both studies.
conclusionsThe maximum studied doses of gaboxadol (GBX15 in adult patients and GBX10 in elderly patients) were effective at enhancing objective polysomnography measures of sleep maintenance and SWS, and also some subjective sleep measures, over 30 nights but had little or no effects on sleep onset. The clinical relevance of the enhancement of SWS by gaboxadol is unclear.
Indexed as
Identifiers
18853933PMC2572741W120037961What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.