SynthesisActa psychiatrica Scandinavica2025
Efficacy and Acceptability of Licensed and Off-Label Pharmacological Interventions for Insomnia in Patients With Severe Mental Illness: A Systematic Review and Meta-Analysis of Randomised Trials.
Synthesis in Acta psychiatrica Scandinavica, 2025. 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.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed, 1 synthesis or guideline pooled it.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
Abstract
backgroundA wide range of drugs is used to alleviate insomnia symptoms in individuals with severe mental illness (SMI), including licensed drugs and sedating drugs prescribed off-label. Yet, no review has gathered the evidence on illness-specific or transdiagnostic outcomes of pharmacological interventions for insomnia. We aimed to perform a systematic review and meta-analysis of randomised controlled trials (RCTs) studying the efficacy and acceptability of pharmacological interventions for insomnia among individuals with SMI, defined as schizophrenia, bipolar disorder (BD) or major depressive disorder (MDD).
methodsWe searched for RCTs of pharmacological interventions for insomnia that used either placebo or another medication as inactive control or active comparator. Two independent reviewers performed the literature screening, data extraction and risk of bias assessment (RoB2). We performed random effects meta-analyses on the co-primary outcomes total sleep time (TST), sleep quality and acceptability (all-cause discontinuation) and the secondary outcomes safety and tolerability.
resultsThe search identified 3331 hits, of which 25 RCTs (n = 2476 individuals) were included, with 18 RCTs (n = 2199) in MDD, 4 RCTs (n = 162) in BD and 3 RCTs (n = 115) in schizophrenia. Of 25 RCTs, 22 had a high risk of bias. The most frequently studied drugs were agomelatine (RCTs = 3, n = 686), eszopiclone (RCTs = 3, n = 599) and zolpidem (RCTs = 3, n = 601). Compared to placebo, pharmacological interventions for insomnia were associated with improved sleep quality by a small effect size (RCTs = 8, g = 0.24, 95% CI = 0.05-0.43) and improved TST (RCTs = 10, MD = 30.82 min, 95% CI = 19.13-42.50), with similar acceptability (RCTs = 10, RR = 1.06, 95% CI = 0.90-1.25). DISCUSSION: Despite their frequent use, many licensed and off-label pharmacological interventions for insomnia have never been investigated in patients with SMI. The studies that provided sufficient data for meta-analysis showed better efficacy with similar acceptability compared to placebo, but the generalizability of these results is limited by the high heterogeneity and low quality of the included studies. This underscores the need for high-quality RCTs to provide a better scientific basis for the pharmacological treatment of insomnia in SMI.
trial registrationCRD42023413787.
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Registered trials
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