Evidence mapPaperPMID 40360261Full record

Trial reportThorax2025

Effect of viloxazine and trazodone in obstructive sleep apnoea: a randomised, placebo-controlled, cross-over study.

Atqiya Aishah, Molly Kim, Laura Gell, Daniel Vena, Ali Azarbarzin, Huy Pho, Daniel Norman, Joseph Ojile, Neda Esmaeili, Luigi Taranto-Montemurro and 3 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Thorax, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05793684 (Phase 2 Randomized Double-Blind Placebo-Controlled Multiple-Dose 3-Period Crossover Study to Compare a Fixed Dose Combination of AD816 to Viloxazine Alone and to Placebo in Obstructive Sleep Apnea), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

NCT05793684 phase2completednot on this map

Phase 2 Randomized Double-Blind Placebo-Controlled Multiple-Dose 3-Period Crossover Study to Compare a Fixed Dose Combination of AD816 to Viloxazine Alone and to Placebo in Obstructive Sleep Apnea

TypeinterventionalSponsorApnimedRan2023 to 2023Enrolled25ConditionsOSA, Obstructive Sleep ApneaArmsPeriod A, Period B, Period C
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Review
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Atqiya AishahHarvard Medical School & Brigham and Women's Hospital, Boston, Massachusetts, USA aaishah@bwh.harvard.edu.ORCID 0000-0001-9383-1724
Molly KimHarvard Medical School & Brigham and Women's Hospital, Boston, Massachusetts, USA.
Laura GellApnimed Inc, Cambridge, Massachusetts, USA.
Daniel VenaHarvard Medical School & Brigham and Women's Hospital, Boston, Massachusetts, USA.
Ali AzarbarzinHarvard Medical School & Brigham and Women's Hospital, Boston, Massachusetts, USA.
Huy PhoApnimed Inc, Cambridge, Massachusetts, USA.
Daniel NormanSanta Monica Clinical Trial, Santa Monica, California, USA.
Joseph OjileClayton Sleep Institute, St Louis, Missouri, USA.
Neda EsmaeiliHarvard Medical School & Brigham and Women's Hospital, Boston, Massachusetts, USA.ORCID 0009-0008-4956-1497
Luigi Taranto-MontemurroHarvard Medical School & Brigham and Women's Hospital, Boston, Massachusetts, USA.
Andrew WellmanHarvard Medical School & Brigham and Women's Hospital, Boston, Massachusetts, USA.
Scott SandsHarvard Medical School & Brigham and Women's Hospital, Boston, Massachusetts, USA.ORCID 0000-0003-3752-0328
Ludovico MessineoHarvard Medical School & Brigham and Women's Hospital, Boston, Massachusetts, USA.

Funding

Validation of a Phenotype Model to Predict Response to Alternative OSA TreatmentsR01HL102321 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI WELLMAN, DAVID ANDREW · 2011 to 2025
$7.3M
NHLBI NIH HHS R01 HL102321
6 · The paper itself

Abstract

introductionCombination of the noradrenergic atomoxetine with either the antimuscarinic aroxybutynin or trazodone has been shown to improve obstructive sleep apnoea (OSA) severity. However, atomoxetine may contribute to apnoea-cycling and reduced drug tolerability due to wake-promoting, especially in a subgroup (poor cytochrome 2D6 metabolisers leading to higher blood concentration of medication). We investigated the effect of a potentially more manageable noradrenergic, viloxazine, with and without trazodone, on OSA severity.

methodsIn this double-blind, placebo-controlled, cross-over study, 24 patients with OSA (18-75 years) were analysed and randomised to 500 mg viloxazine, 500/75 mg viloxazine-trazodone (vilo-trazo) or placebo; taken before bed for 2 weeks with 1-week washout between treatments. In-laboratory polysomnography was performed at the end of each cross-over period. Mixed-model analyses compared the effect of vilo-trazo versus placebo on AHI

resultsVilo-trazo reduced AHI

conclusionsViloxazine-trazodone reduced OSA severity. Potential deleterious effects of viloxazine on sleep quality appeared partly attenuated by trazodone. TRIAL REGISTRATION NUMBER: NCT05793684.

Indexed as

Sleep Apnea, ObstructiveTrazodoneViloxazineAdolescentAdultAgedCross-Over StudiesDouble-Blind MethodDrug Therapy, CombinationFemaleHumansMaleMiddle AgedPolysomnographyTreatment OutcomeYoung AdultTrazodoneViloxazineRespiratory MeasurementSleepSleep apnoea

Identifiers

PMID40360261
PMCPMC12951733

What Socratic holds

Textmetadata
LicenceTDM
Read underepoch 390

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 Socratic graph.