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

Daridorexant for Sleep Disturbance in Adults With Liver Cirrhosis (clinicaltrials.gov) - P4 | N=180 | Not yet recruiting | Sponsor: Wang Fengmei

New P4 trial • CNS Disorders • Fibrosis • Gastroenterology • Hepatic Encephalopathy • Hepatology • Immunology • Liver Cirrhosis • Sleep Disorder

Daridorexant as a novel therapy for chronic insomnia: a systematic review and meta-analysis (ERS 2026) - "Findings provide high-level evidence that daridorexant 50 mg significantly improves key nocturnal sleep parameters and daytime functioning in adults with chronic insomnia, with a favorable safety profile. The consistency of improvements across clinically meaningful outcomes supports daridorexant as an effective and well-tolerated therapeutic option, underscoring its value in the clinical management of chronic insomnia."

Retrospective data • Review • CNS Disorders • Insomnia • Sleep Disorder

Dose-response meta-analysis of dual orexin receptor antagonists on sleep parameters and implications for orexin-mediated arousal. (PubMed, Sleep Med) - "DORAs produce dose-related improvements in insomnia sleep-related outcomes, with most effects plateauing within therapeutic ranges. This pattern is consistent with a pharmacodynamic ceiling whereby sufficient attenuation of orexin-mediated arousal is achieved within approved dose ranges, limiting the value of further dose escalation. These findings do not support supratherapeutic dosing and suggest that clinical response may be better judged after repeated administration."

Journal • Retrospective data • Review • CNS Disorders • Insomnia • Sleep Disorder

Daridorexant- Case Report of Possible Side-Effect in Rare Mitochondrial Disorder. (PubMed, J Sleep Res) - "She developed progression of her MIDD symptoms during treatment. Caution is warranted when initiating daridorexant treatment in patients with mitochondrial disorders."

Adverse events • Journal • CNS Disorders • Diabetes • Insomnia • Metabolic Disorders • Otorhinolaryngology • Sleep Disorder

Long-term use of dual orexin receptor antagonists for the treatment of insomnia: a systematic review and meta-analysis. (PubMed, Arq Neuropsiquiatr) - "Adults with primary insomnia treated with DORAs (suvorexant, lemborexant, or daridorexant) approved by the United States Food and Drug Administration (FDA) for ≥ 6 months were included. Higher doses may be less well tolerated. Additional long-term randomized trials are needed to better define the efficacy and safety of DORAs in clinical practice."

Clinical • Journal • Retrospective data • Review • CNS Disorders • Insomnia • Sleep Disorder

COMISA-PEC: Study on the Management of COMISA (clinicaltrials.gov) - P=N/A | N=150 | Not yet recruiting | Sponsor: University Hospital, Grenoble

New trial • CNS Disorders • Insomnia • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Recommendations on Switching or Deprescribing Hypnotic Medications for Insomnia. (PubMed, Dtsch Arztebl Int) - "A drug-specific approach with evidence-based and practice-oriented protocols should be used when hypnotic medications are switched or discontinued."

Journal • Review • CNS Disorders • Insomnia • Sleep Disorder

Evaluating the Efficacy and Safety of Daridorexant Transition From BZRAs in Insomnia Patients?EASY-TIP? (clinicaltrials.gov) - P4 | N=156 | Not yet recruiting | Sponsor: Xuanwu Hospital, Beijing

New P4 trial • CNS Disorders • Insomnia • Sleep Disorder

Exploratory Study Evaluating Nightly Daridorexant in Patients with Chronic Migraine and Comorbid Insomnia (DORMI Study) (CNSF 2026) - "Should this pilot reveal clinically meaningful improvements in sleep and headache frequency, it would warrant a larger, randomized controlled trial."

Clinical • CNS Disorders • Insomnia • Migraine • Sleep Disorder

The "efficacy window" phenomenon of daridorexant in insomnia treatment: a dose-dependent time-course meta-analysis. (PubMed, Front Pharmacol) - "Daridorexant overall performance is relatively safe, but the 25 mg dose may be associated with an increased risk of AESIs. Identifier, CRD420251174557."

Journal • Retrospective data • Review • CNS Disorders • Insomnia • Sleep Disorder

DIAS: Daridorexant for People With Insomnia and Alcohol Use Disorder Study (clinicaltrials.gov) - P2 | N=205 | Not yet recruiting | Sponsor: Sterling McPherson

New P2 trial • Addiction (Opioid and Alcohol) • CNS Disorders • Insomnia • Psychiatry • Sleep Disorder

Dual orexin receptor antagonists for preventing delirium in hospitalized older adults: protocol for a randomized-trial systematic review and meta-analysis. (PubMed, Syst Rev) - "This protocol addresses a focused clinical question while explicitly separating formal review inclusion from eligibility for the primary quantitative synthesis. This distinction is intended to prevent clinically indirect evidence, including mixed-age data, post-delirium treatment, unbalanced combination regimens, or unvalidated delirium ascertainment, from being interpreted as practice-changing evidence for prevention in hospitalized older adults."

Journal • Retrospective data • Anesthesia • CNS Disorders • Cognitive Disorders • Psychiatry

Real-world experience with daridorexant for insomnia in adults with intellectual disabilities: a retrospective single-centre case series. (PubMed, Drugs Context) - "Daridorexant was associated with marked improvements in sleep quality and quantity, despite complex comorbid sleep, physical, mental and neurodevelopmental disorders. Subject to the limitations of a small, uncontrolled case series, these gains were associated with other reported improvements, including a reduction in challenging behaviours, improved daytime functioning and substantial alleviation of parent and carer burden."

Journal • Real-world evidence • Retrospective data • CNS Disorders • Developmental Disorders • Insomnia • Mental Retardation • Psychiatry • Sleep Disorder

Department of Defense PTSD Adaptive Platform Trial - Intervention C - Daridorexant (clinicaltrials.gov) - P2 | N=200 | Suspended | Sponsor: Global Coalition for Adaptive Research | Recruiting ➔ Suspended

Trial suspension • CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder

Department of Defense PTSD Adaptive Platform Trial - Master Protocol (clinicaltrials.gov) - P2 | N=800 | Suspended | Sponsor: Global Coalition for Adaptive Research | Recruiting ➔ Suspended

Trial suspension • CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder

A 12-months randomized controlled trial of daridorexant for Alzheimer's disease prevention (AAIC 2026) - No abstract available

Clinical • Alzheimer's Disease • CNS Disorders

Preferences for insomnia medication attributes among UK patients with insomnia (CINP 2026) - "Aims & Objectives: The recent PAtient preferences stUdy in inSomnia (PAUSe) investigated preferences for insomnia treatment among patients enrolled in phase III clinical trials of the dual orexin receptor antagonist daridorexant... Patient preferences in the treatment of insomnia were strongly driven by the desire to improve daytime functioning and avoid medication withdrawal effects."

Clinical • CNS Disorders • Insomnia • Sleep Disorder

Evaluation of Daridorexant for insomnia in patients with mental health disorders within Vale Royal Community Mental Health Team (CMHT) (CINP 2026) - "Daridorexant was well tolerated and effective amongst patients with a variety of mental health diagnoses in a natural community setting.It produced clinically meaningful reduction in insomnia severity for those who completed follow-up.Improvement in sleep appeared to correlate with better mental health, daily functioning, and overall wellbeing, highlighting the value of sleep optimisation within mental health care.The small fraction of patients reporting lack of perceived efficacy might reflect expectation of rapid onset of action typically associated with traditional hypnotics.Daridorexant remains a promising option for managing insomnia in patients with complex mental health needs, particularly where traditional hypnotics may be less suitable.Further evaluation in larger cohorts and over longer periods will help clarify durability of benefit and allow for profiling patient groups most likely to respond."

Clinical • CNS Disorders • Insomnia • Psychiatry • Sleep Disorder

Effect of daridorexant on wakefulness throughout the night: post-hoc analysis of a randomised, double-blind, active reference (zolpidem) study in patients with insomnia disorder (CINP 2026) - P2 | "In patients with insomnia disorder, daridorexant reduces the duration of awakenings throughout the entire night, including the last two quarters."

Clinical • Retrospective data • CNS Disorders • Insomnia • Sleep Disorder

Daridorexant in patients with insomnia disorder: number needed to treat, number needed to harm & likelihood to be helped or harmed (CINP 2026) - "Daridorexant 25 mg and 50 mg both have a positive benefit-risk ratio compared with placebo over 3 months. Furthermore, daridorexant 50 mg showed 'good' NNT values (i.e. NNT <10) over all efficacy endpoints in relation to the CMTs."

Clinical • CNS Disorders • Insomnia • Sleep Disorder

Nighttime safety of daridorexant: response to noise stimuli, and effects on postural stability, walking and memory (CINP 2026) - "Following bedtime administration, daridorexant preserved the ability to respond to external noise stimuli and subjects were able to operate safely during the night."

Clinical • CNS Disorders • Insomnia • Sleep Disorder

Esketamine in neuropsychiatric long COVID: a retrospective analysis (CINP 2026) - "Overview of the proposed, stepwise psychopharmacological treatment algorithm for neuropsychiatric Long COVIDTreatment stepTherapeutic strategyRepresentative SubstancesStep IEvidence-based phyto-psychopharmacotherapySilexan, Ginkgo biloba, Rhodiola roseaStep IIAntidepressant treatmentSSRIs, SNRIs, vortioxetine, bupropion, mirtazapineStep IIIAdd-on strategiesaripiprazole, pregabalin, daridorexantStep IVGlutamatergic modulationesketamineTable summarizing a proposed four-step psychopharmacological treatment algorithm for neuropsychiatric Long COVID, with esketamine positioned as the fourth escalation step (Ivkic et al., 2025).References: Badenoch, J. B., Rengasamy, E. R., Watson, C., Jansen, K., Chakraborty, S., Sundaram, R. D., Hafeez, D., Burchill, E., Saini, A., Thomas, L., Cross, B., Hunt, C. K., Conti, I., Ralovska, S., Hussain, Z., Butler, M., Pollak, T. A., Koychev, I., Michael, B. D.,…Rooney, A. G. (2022). These preliminary results suggest that esketamine, applied..."

Retrospective data • Alzheimer's Disease • Bipolar Disorder • CNS Disorders • Cognitive Disorders • Depression • Infectious Disease • Inflammation • Mental Retardation • Metabolic Disorders • Mood Disorders • Novel Coronavirus Disease • Post-traumatic Stress Disorder • Psychiatry • Respiratory Diseases • Sleep Disorder • MMP9

Department of Defense PTSD Adaptive Platform Trial - Master Protocol (clinicaltrials.gov) - P2 | N=800 | Recruiting | Sponsor: Global Coalition for Adaptive Research | Trial completion date: Sep 2026 ➔ Jul 2029 | Trial primary completion date: Mar 2026 ➔ Jul 2028

Trial completion date • Trial primary completion date • CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder

Mechanistic insights into the safety of daridorexant in older adults: From postural stability to next-day function. (PubMed, J Psychopharmacol) - No abstract available

Journal

Real-World Observational Study on Patient-Reported Outcomes in the Treatment of Insomnia With Daridorexant in Canada (clinicaltrials.gov) - P=N/A | N=90 | Completed | Sponsor: PeriPharm | Enrolling by invitation ➔ Completed | Trial completion date: Oct 2025 ➔ May 2026 | Trial primary completion date: Oct 2025 ➔ May 2026

Real-world evidence • Trial completion • Trial completion date • Trial primary completion date • CNS Disorders • Insomnia • Sleep Disorder