Dayvigo (lemborexant) / Eisai - LARVOL DELTA

Neuro-DORA: A Dual Orexin Receptor Antagonist to Reduce Biomarkers of Neurodegeneration in Adults With Insomnia. (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Woolcock Institute of Medical Research | Trial completion date: Apr 2026 ➔ Dec 2027 | Trial primary completion date: Apr 2026 ➔ Dec 2027

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

Effects of lemborexant on chronic insomnia management in patients with COPD (ERS 2026) - "Lemborexant was associated with favorable effects on lung function and COPD-related symptoms, with a trend toward better psychiatric status. Lemborexant appears to be a safe and potentially beneficial treatment option for chronic insomnia in patients with COPD."

Clinical • Chronic Obstructive Pulmonary Disease • CNS Disorders • Immunology • Insomnia • Respiratory Diseases • Sleep Disorder

Dual orexin receptor antagonist-assisted dose reduction of benzodiazepines and benzodiazepine receptor agonists: a mirror-image analysis of insurance claims data. (PubMed, J Clin Sleep Med) - "DORA treatment for at least six months may support BZ/BZRA dose reduction among long-term users, particularly in older patients."

Journal • Reimbursement • US reimbursement • CNS Disorders • Insomnia • Sleep Disorder

Lemborexant on Perioperative Sleep Quality in Patients Undergoing Thoracoscopic Surgery (clinicaltrials.gov) - P2 | N=130 | Not yet recruiting | Sponsor: Beijing Tiantan Hospital

New P2 trial • CNS Disorders • 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

LemboCAN: Lemborexant for Cannabis Use Disorder (clinicaltrials.gov) - P1/2 | N=28 | Not yet recruiting | Sponsor: University of Calgary

New P1/2 trial • Substance Abuse

ELOSA: Effects of Eszopiclone and Lemborexant in People With OSA With a Low Arousal Threshold Who Have Difficulty Sleeping (clinicaltrials.gov) - P2 | N=15 | Recruiting | Sponsor: Flinders University | Not yet recruiting ➔ Recruiting

Enrollment open • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Apnea • Sleep Disorder

Vornorexant versus Lemborexant for Insomnia Disorder: A Systematic Review and Network Meta-analysis. (PubMed, Int J Neuropsychopharmacol) - "Dosage variations could influence both the clinical efficacy and safety profile of these agents."

Journal • Cataplexy • CNS Disorders • Fatigue • Insomnia • Pain • Sleep Disorder

Bridging Psychiatry and Primary Care: A Biologically Informed Suicide Prevention Model (WFSBP 2026) - "Case A — escitalopram brand switch in a stably remitted patient producing emotional blunting and partial efficacy loss despite identical labelled dose, traceable to altered dissolution and excipient-mediated changes in CNS serotonergic tone...Case C — paroxetine switch precipitating SSRI discontinuation syndrome ("electric shocks," dizziness, anxiety) misdiagnosed as relapse: the patient was relabelled rather than re-formulated. Case D — clozapine post-procurement change producing sedation and hypersalivation reframed by clinicians as "tolerance loss." The common pathophysiology across signals is peak–trough variability, altered Cmax / Tmax, excipient-driven absorption variance, and polymorphic dissolution behaviour — none of which are captured by single-dose healthy-volunteer bioequivalence studies. The orphan-comparator problem is introduced (e.g., lemborexant has only one marketed brand in India: tolerability change cannot be scientifically..."

Clinical • CNS Disorders • Mood Disorders • Movement Disorders • Psychiatry

Letter: Efficacy and Safety of Lemborexant in Cirrhosis-Promise, Caveats and Nuanced Interpretation of Dose-Dependent Cognitive Effects. (PubMed, Aliment Pharmacol Ther) - No abstract available

Journal • Fibrosis • Immunology

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

Letter: Careful Interpretation of Lemborexant Efficacy and Safety in Patients With Cirrhosis. Authors' Reply. (PubMed, Aliment Pharmacol Ther) - No abstract available

Journal • Fibrosis • Immunology

Letter: The Promotion of Lemborexant in Patients With Liver Cirrhosis and Insomnia-Limitations of Population Generalisation and Liver Safety. (PubMed, Aliment Pharmacol Ther) - No abstract available

Journal • CNS Disorders • Fibrosis • Gastroenterology • Hepatology • Immunology • Insomnia • Liver Cirrhosis • Sleep Disorder

Lemborexant produces antidepressant- and anxiolytic-like effects with sleep-wake regulation compared with fluoxetine in male mice with comorbid depression and insomnia. (PubMed, Neuropharmacology) - "Notably, improvements in REM sleep continuity were strongly associated with affective recovery. Together, these findings indicate that LEM exerts antidepressant- and anxiolytic-like effects while modulating sleep in a comorbid depression-insomnia model, providing preclinical evidence for DORAs as a potential therapeutic strategy for MDD with sleep disturbances."

Journal • Preclinical • CNS Disorders • Depression • Insomnia • Major Depressive Disorder • Mood Disorders • Psychiatry • Sleep Disorder

A Modified Delphi Consensus on Optimal Pharmacological Management of Insomnia: Insights from a Malaysian Perspective. (PubMed, Malays J Med Sci) - "DORAs demonstrated promise in managing both sleep onset and maintenance, with lemborexant highlighted as a promising pharmacological option...The integration of Cognitive Behavioural Therapy for Insomnia with pharmacotherapy was strongly advocated. These consensus statements offer a practical foundation for the development of future national guidelines to enhance insomnia care in Malaysia's primary care settings."

Journal • Review • CNS Disorders • Insomnia • Psychiatry • Sleep Disorder

Lemborexant for the Treatment of Residual Insomnia in Major Depressive Disorder (MDD) (clinicaltrials.gov) - P2 | N=30 | Terminated | Sponsor: Unity Health Toronto | Trial completion date: Apr 2028 ➔ Jul 2026 | Recruiting ➔ Terminated | Trial primary completion date: Dec 2027 ➔ Jul 2026; Funding withdrawn by sponsor.

Trial completion date • Trial primary completion date • Trial termination • CNS Disorders • Depression • Insomnia • Major Depressive Disorder • Mental Retardation • Mood Disorders • Psychiatry • Sleep Disorder

Efficacy of Lemborexant in Insomnia Disorder Patients With and Without Comorbid Circadian Rhythm Sleep-Wake Disorders: A Dual-Cohort Study (ChiCTR) - P=N/A | N=150 | Not yet recruiting | Sponsor: Southern Medical University Southern Hospital; Southern Medical University Southern Hospital

New trial • CNS Disorders • Insomnia • Sleep Disorder • Sleep Wake Cycle Disorder

Letter: Careful Interpretation of Lemborexant Efficacy and Safety in Patients With Cirrhosis. (PubMed, Aliment Pharmacol Ther) - No abstract available

Journal • Fibrosis • Immunology

A plain language summary: an overview of objective (scientific) data and patient experiences showing how effective lemborexant is for treating insomnia. (PubMed, Postgrad Med) - No abstract available

Journal • CNS Disorders • Fatigue • Insomnia • Sleep Disorder

Eisai wins EMA acceptance for lemborexant insomnia filing in Europe (International Business Times) - "The application covers chronic insomnia in adults."

EMA filing • Insomnia

Lemborexant Use for Cognition Improvement in Postoperative Delirium in Elderly Patients: A Randomized Controlled Trial (clinicaltrials.gov) - P2 | N=992 | Not yet recruiting | Sponsor: Beijing Tiantan Hospital

New P2 trial • CNS Disorders • Geriatric Disorders

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

Evaluation of Oculomotor Function Following Sleep Improvement With Lemborexant in Older Adults With Insomnia. (PubMed, Hum Psychopharmacol) - "Selected eye movement metrics were modestly associated with improvements in subjective sleep symptoms following hypnotic treatment in older adults with insomnia."

Journal • CNS Disorders • Insomnia • Sleep Disorder

Eisai…announced today that the United Kingdom’s (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA) has accepted for evaluation a marketing authorization application (MAA) for its in-house-discovered and developed orexin receptor antagonist lemborexant for the treatment of adult patients with insomnia, characterised by symptoms present for at least 3 months… (Eisai Press Release)

MHRA filing • Insomnia • Sleep Disorder

Clinical Trial: Lemborexant Efficacy and Safety in Liver Cirrhosis-Randomized, Double-Blind, Crossover Clinical Trial. (PubMed, Aliment Pharmacol Ther) - P2 | "Our study supported the efficacy and safety of Lemborexant, particularly at 5 mg, against sleep problems in cirrhosis. Larger studies with longer follow-up are warranted to strengthen evidence."

Clinical • Journal • CNS Disorders • Fibrosis • Gastroenterology • Hepatic Encephalopathy • Hepatology • Immunology • Insomnia • Liver Cirrhosis • Sleep Disorder