Evidence map›Paper›PMID 41177901›Full record

SynthesisJournal of sleep research2026

Effects of Agomelatine on Sleep Across Populations: A Systematic Review and Meta-Analysis.

Anastasios Stefanou, Ioannis Anastasiou, Panagiota Fallon, Eleni Glarou, Nikolaos Christodoulou, Andreas S Lappas, Vasilios-Panteleimon Bozikas, Myrto T Samara

Abstract readSystematic ReviewMeta-Analysis
In one paragraph

Synthesis in Journal of sleep research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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

8 authors.

Anastasios StefanouSecond Department of Psychiatry, Department of Medicine, School of Health Sciences, Aristotle University of Thessaloniki, Thessaloniki, Greece.ORCID 0009-0005-7721-0377
Ioannis AnastasiouMedical School, University of Thessaly, Larisa, Greece.
Panagiota FallonMedical School, University of Thessaly, Larisa, Greece.ORCID 0000-0003-4262-456X
Eleni GlarouCentre for Trials Research, Cardiff University, Cardiff, UK.ORCID 0000-0001-5666-2458
Nikolaos ChristodoulouDepartment of Psychiatry, School of Medicine, University of Thessaly, Larissa, Greece.
Andreas S LappasDepartment of Psychiatry, School of Medicine, University of Thessaly, Larissa, Greece.
Vasilios-Panteleimon BozikasSecond Department of Psychiatry, Department of Medicine, School of Health Sciences, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Myrto T SamaraDepartment of Psychiatry, School of Medicine, University of Thessaly, Larissa, Greece.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Agomelatine, a melatoninergic antidepressant, is often prescribed to improve sleep disturbance, though meta-analytic evidence is currently lacking. This systematic review and meta-analysis assessed its efficacy and tolerability in sleep outcomes compared to placebo. We systematically searched clinical trial registries (Cochrane Central, WHO ICTRP, ClinicalTrials.gov) and databases (MEDLINE, Embase, APA PsycINFO) up to February 16, 2025, for Randomised Controlled Trials (RCTs) comparing agomelatine with placebo that reported sleep-related outcomes. Analyses were conducted using a random-effects model on an intention-to-treat basis. Risk ratios (RR) were used for dichotomous outcomes, weighted mean differences (WMD) for continuous outcomes, and Hedge's adjusted g (SMD) when different scales were used. Primary outcomes included subjective and objective total sleep time, subjective sleep quality, and treatment-emergent somnolence and insomnia. Subgroup and sensitivity analyses explored heterogeneity and assessed robustness. Twenty-five RCTs with 6812 participants were included. No significant effect was found for objective total sleep time (MD = -15.73 min, 95% CI: -49.68; 18.22), while subjective sleep quality improved more with agomelatine than placebo (SMD = 0.31, 95% CI: 0.21; 0.40). Agomelatine was associated with fewer incidents of insomnia (RR = 0.59, 95% CI: 0.39; 0.90) but more incidents of somnolence (RR = 1.34, 95% CI: 1.02; 1.75). Agomelatine was found to cause marginally more adverse effects than placebo (RR = 1.05, 95% CI: 1.00; 1.11). Overall, agomelatine appears to slightly improve sleep quality and is well-tolerated and safe, although the limited data for many outcomes warrant cautious interpretation.

Indexed as

AcetamidesHypnotics and SedativesSleepSleep Initiation and Maintenance DisordersSleep QualityHumansNaphthalenesRandomized Controlled Trials as TopicAcetamidesagomelatineHypnotics and SedativesNaphthalenesagomelatinemeta‐analysisplacebosleepsleep qualitysystematic review

Identifiers

PMID41177901
PMCPMC13193371

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.