Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health, Nxera Pharma, Simcere, Shionogi, Holling Bio-Pharma - LARVOL DELTA

Unveiling the binding mechanism of orexin 2 receptor antagonists with computational chemistry. (PubMed, Phys Chem Chem Phys) - "In this study, we investigated the molecular interactions of three dual orexin receptor antagonists (daridorexant, lemborexant, suvorexant) and the selective OXR2 antagonist seltorexant using an integrated computational approach that combined classical molecular docking, explicit-membrane molecular dynamics (MD) simulations of 700 ns, and quantum-based molecular fractionation with conjugate caps (MFCC) calculations coupled with density functional theory (DFT) at the B97D/6-311+G(d,p) level. These findings shed light on the structural and energetic factors that determine OXR2-ligand recognition. The results provide a solid molecular framework for the rational optimization of orexin receptor antagonists with enhanced selectivity and improved pharmacological profiles."

Journal • CNS Disorders • Mental Retardation • Psychiatry

Daridorexant treatment in adolescents with enuresis. (clinicaltrialsregister.eu) - P2/3 | N=20 | Recruiting | Sponsor: Region Midtjylland | Not yet recruiting ➔ Recruiting

Enrollment open • Urinary Incontinence

CELESTE: Comparing Digital Therapy, Trazodone, and Daridorexant for Menopause-Related Insomnia Symptoms (clinicaltrials.gov) - P4 | N=1000 | Recruiting | Sponsor: Brigham and Women's Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • HEOR • CNS Disorders • Insomnia • Sleep Disorder

What place does daridorexant have in the treatment of binge-eating disorder? (PubMed, Expert Rev Neurother) - No abstract available

Journal • Binge Eating Disorder • CNS Disorders • Sleep Disorder

Daridorexant: exploring its role in the treatment of insomnia disorder. (PubMed, Expert Rev Neurother) - "Head-to-head comparisons with standard insomnia hypnotics are limited to a Phase 2 dose-finding study. Its favorable safety profile makes daridorexant appropriate for many patients, including older adults."

Journal • Review • CNS Disorders • Insomnia • Sleep Disorder

Targeted solutions: daridorexant insights in insomnia disorder during menopausal transition (ISGE 2026) - "Sponsored by Idorsia"

CNS Disorders • Insomnia • Sleep Disorder

Nxera Pharma Co., Ltd…announces that it has submitted a marketing authorisation application (MAA) to the Ministry of Food and Drug Safety (MFDS) in South Korea for daridorexant, a dual orexin receptor antagonist, for the treatment of adult patients with insomnia. (GlobeNewswire) - "This submission follows positive data from the Phase 3 trial of daridorexant in South Korea which met both primary and secondary efficacy endpoints."

Korea filing • Insomnia

Efficacy and safety of daridorexant in women with insomnia disorder during menopausal transition: a subgroup analysis (ISGE 2026) - P3 | "These post-hoc exploratory analyses suggest that daridorexant 50 mg improves sleep outcomes and daytime functioning and is well tolerated in women aged 47-55 years with insomnia disorder. Disclosures: Funded by Idorsia Pharmaceuticals Ltd."

Clinical • CNS Disorders • Insomnia • Sleep Disorder

Dose-finding Study Assessing the Efficacy, Safety, and Pharmacokinetics of Daridorexant in Subjects Aged 10 to < 18 Years With Insomnia Disorder (clinicaltrials.gov) - P2 | N=166 | Completed | Sponsor: Idorsia Pharmaceuticals Ltd. | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Insomnia • Pediatrics • Sleep Disorder

Efficacy and Safety of Daridorexant in Women with Hypothyroidism and Insomnia Disorder: A Subgroup Analysis (ISGE 2026) - P3 | "This post-hoc analysis suggests that daridorexant 50 mg improves objective and subjective sleep outcomes and daytime functioning, with a favorable tolerability profile, in women with hypothyroidism and insomnia disorder. Disclosures: Funded by Idorsia Pharmaceuticals Ltd."

Clinical • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Endocrine Disorders • Insomnia • Sleep Disorder

Real-world findings of daridorexant in chronic insomnia: A pilot study on subjective and actigraphic sleep parameters. (PubMed, Sleep Med) - "Overall, these findings provide preliminary real-world evidence of associations between daridorexant use and subjective and objective sleep parameters. The observed signals, particularly regarding sleep misperception, should be considered hypothesis-generating and require confirmation in larger, controlled studies."

Journal • Real-world evidence • CNS Disorders • Insomnia • Sleep Disorder

Clinical toxicity of daridorexant: a retrospective analysis of poison centre data. (PubMed, Clin Toxicol (Phila)) - "While daridorexant appears safe when taken alone, clinicians should remain vigilant in polypharmacy scenarios involving central nervous system depressants. Further studies are needed to confirm sex-related differences and refine risk stratification in overdose management."

Journal • Retrospective data • Addiction (Opioid and Alcohol) • Cardiovascular • CNS Disorders • Depression • Hypoglycemia • Insomnia • Otorhinolaryngology • Pain • Pediatrics • Psychiatry • Sleep Disorder • Vertigo

Investigation of a simple suspension method for orexin receptor antagonist tablets. (PubMed, J Pharm Health Care Sci) - No abstract available

Journal

Comparative effects of hypnotic agents on sleep architecture and respiratory outcomes in obstructive sleep apnea: A systematic review and network meta-analysis. (PubMed, Psychiatry Clin Neurosci) - "Our network meta-analysis identified different effects of various hypnotics on sleep architecture and respiratory parameters; however, the lack of data prevented a formal synthesis of subjective outcomes. Therefore, these results should be interpreted with caution in clinical practice."

Journal • Retrospective data • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Sleep, wake, and signaling: Functional profiling of orexin agonists and antagonists using newly developed orexin β-arrestin 2 and miniGαq recruitment assays. (PubMed, Eur J Pharmacol) - "These assays were successfully applied to evaluate the pharmacological profiles of both agonists and antagonists, including the endogenous ligands orexin-A and -B, the clinically approved small molecule antagonists suvorexant and daridorexant, as well as EMPA (N-ethyl-2-[(6-methoxy-pyridin-3-yl)-(toluene-2-sulphonyl)-amino]-N-pyridin-3-ylmethyl-acetamide) and four other compounds described in literature to act at orexin receptors. The obtained receptor activation patterns and selectivity profiles were consistent with literature data, indicating the reliability and robustness of the assay systems. Overall, the newly developed assays expand the toolkit for orexin receptor research by allowing the characterization of both agonists and antagonists, thereby contributing to the functional characterization of potential new drug candidates for various pathological conditions."

Journal • CNS Disorders • Insomnia • Narcolepsy • Sleep Disorder • ARRB1

DORMI Study: Daridorexant treatment in adults with migraine and insomnia: an exploratory study of sleep and headache outcomes (ANZCTR) - P4 | N=25 | Not yet recruiting | Sponsor: Vivek Milan Keshani at Sunnybrook Hopsital, Toronto, Ontario

New P4 trial • CNS Disorders • Insomnia • Migraine • Pain • Sleep Disorder

A Study to Evaluate the Efficacy and Safety of Daridorexant in Participants With Insomnia Disorder (clinicaltrials.gov) - P3 | N=164 | Completed | Sponsor: Nxera Pharma Korea Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Insomnia • Sleep Disorder

Dose-finding Study Assessing the Efficacy, Safety, and Pharmacokinetics of Daridorexant in Subjects Aged 10 to < 18 Years With Insomnia Disorder (clinicaltrials.gov) - P2 | N=150 | Active, not recruiting | Sponsor: Idorsia Pharmaceuticals Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Insomnia • Pediatrics • Sleep Disorder

Impact of Daridorexant on Sleep, Daytime Alertness, and Smoking (clinicaltrials.gov) - P4 | N=44 | Not yet recruiting | Sponsor: Legacy Health System

New P4 trial • CNS Disorders • Insomnia • Psychiatry • Sleep Disorder • Tobacco Addiction

Orexin Receptor Antagonism Improves Sleep Quality and Mitigates Lipopolysaccharide-Induced Inflammatory Responses in a Mouse Model. (PubMed, FASEB J) - "In this study, our aim was to elucidate the role of orexin in sleep and inflammatory states through the examination of a lipopolysaccharide (LPS)-induced systemic inflammatory model and the effects of daridorexant, a dual orexin receptor antagonist...These findings suggest that by reducing pro-inflammatory cytokine expression, the inhibition of orexin activity mitigates the lethargy associated with systemic inflammation, while also improving sleep quality. This study explores the potential of orexin receptor antagonists as strategic options for inflammatory pathologies and their associated sleep disorders."

Journal • Preclinical • CNS Disorders • Inflammation • Pneumonia • Sleep Disorder • CCL2 • CXCL1

Efficacy and safety of daridorexant for the treatment of insomnia disorder in women of menopausal transition age: Insights from a randomized controlled trial. (PubMed, Maturitas) - P3 | "These analyses suggest that daridorexant 50 mg provides benefit in sleep outcomes and daytime functioning in women aged 47-55 with insomnia disorder. Daridorexant 50 mg is well tolerated in this population, with no increased risk of next-morning sleepiness or somnolence."

Clinical • Journal • CNS Disorders • Fatigue • Insomnia • Sleep Disorder

Evaluating the Safety of Prescription Sleep Medications in Patients Undergoing Total Knee Arthroplasty: A Propensity Matched Analysis. (PubMed, J Am Acad Orthop Surg) - "Use of any prescription sleep medication or only standard sleep medications is associated with increased surgical complications. Additional research is needed to find medications that may be safer for routine postoperative use."

Journal • CNS Disorders • Musculoskeletal Diseases • Orthopedics • Pain • Psychiatry • Sleep Disorder

Exploratory study evaluating nightly daridorexant in patients with chronic migraine and comorbid insomnia (DORMI Study) (EHF-EHC 2025) - "Should this pilot reveal clinically meaningful improvements in sleep and headache frequency, it would warrant further investigation through a larger, randomized controlled trial."

Clinical • CNS Disorders • Insomnia • Migraine • Pain • Sleep Disorder

CELESTE: Comparing Digital Therapy, Trazodone, and Daridorexant for Menopause-Related Insomnia Symptoms (clinicaltrials.gov) - P4 | N=1000 | Not yet recruiting | Sponsor: Brigham and Women's Hospital | Trial completion date: Jan 2030 ➔ Feb 2031 | Trial primary completion date: Jan 2030 ➔ Feb 2031

HEOR • Trial completion date • Trial primary completion date • CNS Disorders • Insomnia • Sleep Disorder

PAD-DORA: Daridorexant for Alzheimer Disease Prevention (clinicaltrials.gov) - P2 | N=240 | Recruiting | Sponsor: Douglas Mental Health University Institute | Not yet recruiting ➔ Recruiting

Enrollment open • Alzheimer's Disease • CNS Disorders • Plasma Aβ40