Trial reportClinical pharmacology and therapeutics2022
Driving Performance after Bedtime Administration of Daridorexant, Assessed in a Sensitive Simulator.
Trial report in Clinical pharmacology and therapeutics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 2 of them syntheses that pooled it.
What it found
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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
17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 33 citations in OpenAlex.
- The "efficacy window" phenomenon of daridorexant in insomnia treatment: a dose-dependent time-course meta-analysis.Frontiers in pharmacology · 2026Pooled it
- Guideline for evaluating the effects of psychotropic drugs on motor vehicle driving performance in Japan: A tiered approach for the assessment of clinically meaningful driving impairment.Neuropsychopharmacology reports · 2024Guideline
- Driving performance in the morning after bedtime vornorexant administration: A randomized clinical trial using a driving simulator.Psychiatry and clinical neurosciences · 2025Trial
- The Effects of Elinzanetant on Simulated Driving Performance in Healthy Women: A Randomized Phase I Study.Clinical and translational science · 2025Trial
- Trial
- Long-Term Safety and Tolerability of Daridorexant in Patients with Insomnia Disorder.CNS drugs · 2023Trial
- The sleep-wake cycle: molecular mechanisms, disorders, and therapeutic targets in the context of energy metabolism.Signal transduction and targeted therapy · 2026Review
- Evaluating and Determining the Effects of Psychotropic Drugs on Motor Vehicle Driving Performance: Key Considerations of the Japanese Guideline and Criteria for Clinical Implementation of Evidence.Neuropsychopharmacology reports · 2026Review
- Targeting the Orexin System in the Pharmacological Management of Insomnia and Other Diseases: Suvorexant, Lemborexant, Daridorexant, and Novel Experimental Agents.International journal of molecular sciences · 2025Review
- A scoping review of motor vehicle operator performance assessments for benzodiazepine receptor agonists.Exploratory research in clinical and social pharmacy · 2024Article
- Preclinical metabolism and the disposition of vornorexant/TS-142, a novel dual orexin 1/2 receptor antagonist for the treatment of insomnia.Pharmacology research & perspectives · 2024Article
- Emerging and upcoming therapies in insomnia.Translational and clinical pharmacology · 2024Article
- Utilizing Technology to Enhance the Ecological Validity of Cognitive and Functional Assessments in Schizophrenia: An Overview of the State-of-the-Art.Schizophrenia bulletin open · 2024Article
- The abuse potential of lemborexant, a dual orexin receptor antagonist, according to the 8 factors of the Controlled Substances Act.Psychopharmacology · 2023Review
- Daridorexant in Insomnia Disorder: A Profile of Its Use.CNS drugs · 2023Article
- Daridorexant: A New Dual Orexin Receptor Antagonist for Insomnia.The Journal of pharmacy technology : jPT : official publication of the Association of Pharmacy Technicians · 2022Review
- A Comprehensive Review of Daridorexant, a Dual-Orexin Receptor Antagonist as New Approach for the Treatment of Insomnia.Molecules (Basel, Switzerland) · 2022Review
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 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Use of hypnotics is often associated with next-morning residual effects and a higher risk of motor vehicle accidents. Measuring next-morning effects on driving performance is therefore advised by regulatory agencies. Here, we examined driving performance following administration of daridorexant, a new dual orexin receptor antagonist developed to treat insomnia. Sixty healthy male and female subjects (50-79 years of age) were randomized in a placebo- and active-controlled, four-way cross-over study. Each subject received evening administration of daridorexant 50 and 100 mg, zopiclone 7.5 mg, and placebo, in separate treatment phases of 4 days. Simulated driving performance was assessed after initial (day 2) and repeated dosing (day 5), 9 hours postdose. Standard deviation of the lateral position (SDLP) was the main outcome. On both days, with zopiclone, SDLP increased significantly compared with placebo, which confirmed sensitivity of the simulator. With daridorexant, on day 2, the placebo-corrected mean (97.5% confidence interval) SDLP increased by 2.19 cm (0.46-3.93) and 4.43 cm (2.72-6.15) for 50 and 100 mg, respectively. On day 5, SDLP values for both daridorexant doses were significantly below the prespecified threshold of impairment (2.6 cm) and statistically not different from placebo. Daridorexant showed a lower self-rated driving quality and higher effort compared to placebo on day 2 but not on day 5. In non-insomnia subjects, daridorexant impaired simulated driving after initial but not after repeated dosing. Subjects should be cautioned about driving until they know how daridorexant affects them.
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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.