Evidence map›Paper›PMID 40083090›Full record

Trial reportJournal of sleep research2025

A randomised crossover trial of daridorexant for the treatment of chronic insomnia and nocturia.

Katharina Lederer, Heike Benes, Alan Fine, Sylvia Shoffner, Sandro Bacchelli, David Castro Diaz, Jose Emilio Batista, Racheal Rowles, Tobias Di Marco, Michael Meinel

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of sleep research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the 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.

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

3 citing papers in PubMed.

  1. Trial
  2. Effects of Vornorexant, a Dual Orexin Receptor Antagonist, on Bladder Function in Rats and Nocturnal Voiding Frequency in Patients With Insomnia.International journal of urology : official journal of the Japanese Urological Association · 2026
    Article
  3. Article
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

10 authors.

Katharina LedererAdvanced Sleep Research GmbH, Berlin, Germany.
Heike BenesSomni Bene, Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH, Schwerin, Germany.
Alan FineClinical Research Center of Florida, Pompano Beach, Florida, USA.
Sylvia ShoffnerAccellacare Research of Cary, Cary, North Carolina, USA.
Sandro BacchelliEncore Medical Research of Weston LLC, Weston, Florida, USA.
David Castro DiazComplejo Hospitalario Universitario de Canarias, Tenerife, Spain.
Jose Emilio BatistaUroclinica Barcelona, Centro Médico Teknon, Barcelona, Spain.
Racheal RowlesIdorsia Pharmaceuticals Ltd, Allschwil, Switzerland.
Tobias Di MarcoIdorsia Pharmaceuticals Ltd, Allschwil, Switzerland.
Michael MeinelIdorsia Pharmaceuticals Ltd, Allschwil, Switzerland.

Funding

Idorsia Pharmaceuticals
6 · The paper itself

Abstract

This double-blind, placebo-controlled, two-way crossover trial evaluated the efficacy and safety of daridorexant in patients with chronic insomnia and comorbid nocturia. In total, 60 patients aged ≥55 years with insomnia complaints for ≥3 months, Insomnia Severity Index (ISI) ≥13 and ≥3 voids/night for ≥1 month were randomised (1:1) to daridorexant 50 mg/placebo for 4 weeks followed by crossover after a 14-21-day washout period. The primary endpoint was change from baseline to Week (W) 4 in self-reported total sleep time (sTST). Other endpoints included change in ISI score, sleep depth and quality (visual analogue scale scores), nocturnal voids (mean number, time to first) and daytime functioning (Insomnia Daytime Symptoms and Impacts Questionnaire score [IDSIQ]). At W4, daridorexant significantly increased sTST versus placebo (least-squares mean difference [LSMD] 20.9 min, 95% confidence interval [CI] 8.0-33.7; p = 0.002); significant improvements were also seen at W1-3. Compared with placebo, daridorexant significantly decreased (p < 0.001) ISI at both timepoints, W2 (LSMD -3.7, 95% CI -5.1 to -2.3) and W4 (LSMD -3.3, 95% CI -4.7 to -1.8) and significantly improved (p < 0.05) sleep depth (W1, 2, 3, 4), sleep quality (W1, 2, 3) and IDSIQ total score (W1, 3). Daridorexant versus placebo reduced the number of voids (LSMD [95% CI]: W1-0.6 [-0.9 to -0.3], p < 0.001; W4-0.3 [-0.7 to +0.1], p = 0.090) and increased median time to first void (difference to placebo, W1: +31 min, p = 0.0027; W4: +23 min, p = 0.2026). No adverse events of special interest (falls/urinary incontinence) were reported during daridorexant treatment. In conclusion, in patients with chronic insomnia and nocturia, daridorexant improves both conditions with a favourable safety profile.

Indexed as

NocturiaPyrrolidinesSleep Initiation and Maintenance DisordersAgedCross-Over StudiesDouble-Blind MethodFemaleHumansImidazolesMaleMiddle AgedOrexin Receptor AntagonistsSleep QualityTreatment OutcomedaridorexantImidazolesOrexin Receptor AntagonistsPyrrolidinesdaridorexantdual orexin receptor antagonistinsomnianocturiatotal sleep timevoids

Identifiers

PMID40083090
PMCPMC12592811

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.