Dayvigo (lemborexant) / Eisai - LARVOL DELTA

Gut Microbiome Composition Changes During Insomnia Treatment with Lemborexant. (PubMed, Nat Sci Sleep) - "There were no significant differences in SCFAs during the treatment period. Our findings suggest that prolonged lemborexant treatment in individuals with insomnia may induce notable shifts in gut microbiota composition, including a significant reduction in Parabacteroides underscoring the potential interaction between hypnotic use and gut microbial balance."

Journal • CNS Disorders • Insomnia • Sleep Disorder

Comparison of efficacy and safety of dual orexin receptor antagonists lemborexant and daridorexant for the treatment of insomnia: a systematic review and meta-analysis. (PubMed, Psychopharmacology (Berl)) - "Both LEM and DAR are effective and generally safe options for the treatment of insomnia, with LEM showing greater efficacy in improving WASO and sSOL. The choice between LEM and DAR should consider individual patient needs, including the risk of daytime drowsiness and other adverse events. Further direct comparative trials are needed to confirm these findings and inform clinical decision-making."

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

Adverse events of pharmacological interventions for insomnia disorder in adults: a systematic review and network meta-analysis. (PubMed, Front Psychiatry) - "Compared with placebo, zolpidem (somnolence: relative risk [RR] 1.85; dizziness: RR 2.33; headache: RR 1.26), zopiclone (somnolence: RR 2.02; dizziness: RR 2.33; dysgeusia: RR 7.84), indiplon (somnolence: RR 3.46; dizziness: RR 2.30; headache: RR 1.63), gaboxadol (dizziness: RR 3.44), eszopiclone (somnolence: RR 2.00; dizziness: RR 3.18; dysgeusia: RR 10.54), estazolam (somnolence: RR 2.08), flunitrazepam (somnolence: RR 3.04), flurazepam (somnolence: RR 2.52), lemborexant (somnolence: RR 6.57), nitrazepam (somnolence: RR 3.80), Ramelteon (somnolence: RR 2.19), suvorexant (somnolence: RR 3.32), Temazepam (somnolence: RR 3.77), trazodone (somnolence: RR 2.86), triazolam (somnolence: RR 2.35), and esmirtazapine (somnolence: RR 4.63; dizziness: RR 2.87) had the most harmful profile in nervous system disorders...Data on some drugs like flurazepam, nitrazepam, triazolam, and zaleplon in some outcomes were mainly based on limited study with rare event and thus was highly..."

Adverse events • Journal • Retrospective data • Review • CNS Disorders • Gastroenterology • Gastrointestinal Disorder • Infectious Disease • Insomnia • Otorhinolaryngology • Pain • Psychiatry • Respiratory Diseases • Sinusitis • Sleep Disorder • Xerostomia

Silent nights: Adjunctive lemborexant for managing nighttime agitation and sleep disturbances in Alzheimer's dementia. (PubMed, Int Psychogeriatr) - No abstract available

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Sleep Disorder

Effect of lemborexant on sleep parameters in moderate-to-severe OSA patients with low arousal threshold (ERS 2025) - No abstract available

Clinical • Obstructive Sleep Apnea

Molecular Insights into the Interaction of Orexin 1 Receptor Antagonists: A Comprehensive Study Using Classical and Quantum Computational Methods. (PubMed, Molecules) - "In this study, we investigate the molecular interactions of three OXR1 antagonists-daridorexant, lemborexant, and suvorexant-using an integrated computational approach combining molecular dynamics (MD) simulations, density functional theory (DFT) calculations, and the molecular fractionation with conjugate caps (MFCC) methodology. By elucidating drug-receptor interactions at the atomic level, this research underscores the impact of integrated computational approaches in drug discovery. It supports the development of precise targeted therapies for sleep disorders."

Journal • Alzheimer's Disease • Cardiovascular • CNS Disorders • Cognitive Disorders • Insomnia • Narcolepsy • Sleep Disorder

The determination of the novel insomnia medication lemborexant using a validated liquid chromatography-tandem mass spectrometry method, and its quantitation in clinical and forensic samples. (PubMed, Forensic Toxicol) - "The validated LC-MS/MS method proved effective for detecting and quantifying lemborexant in both clinical and forensic autopsy samples. The study highlights the importance of monitoring lemborexant and other dual orexin receptor antagonists (DORAs) in forensic investigations to understand their pharmacokinetics and potential toxicological effects."

Journal • CNS Disorders • Insomnia • Sleep Disorder

Management of Subsyndromal Delirium With Daridorexant and Quetiapine: A Case Report. (PubMed, Cureus) - "Lemborexant was initiated on postoperative day (POD) 6 and titrated to the maximum dose of 10 mg on POD 8, but it caused morning drowsiness that interfered with participation in rehabilitation. Daridorexant, a dual orexin receptor antagonist (DORA) with a shorter half-life, appeared effective in reducing morning drowsiness. As the use of short-acting benzodiazepines has a potential risk of inducing delirium, the combination of daridorexant and low-dose quetiapine may present a therapeutic option for managing SSD with delayed awakening in the postoperative setting."

Journal • CNS Disorders • Cognitive Disorders • Critical care • Esophageal Cancer • Head and Neck Cancer • Infectious Disease • Insomnia • Mental Retardation • Oncology • Pneumonia • Psychiatry • Pulmonary Disease • Respiratory Diseases • Sleep Disorder • Solid Tumor

Impact of Promotional Activities on Orexin Receptor Antagonists Prescription Rates and Usage of Sleep and Antipsychotic Medications: An Interrupted Time-series Analysis Study (PubMed, Yakugaku Zasshi) - "The drugs analyzed included lemborexant, zolpidem and eszopiclone (NBDs), and risperidone and quetiapine (DTAs). Promoting ORAs increased its use, and led to a reduction in the prescriptions of NBDs and DTAs with abnormal indications. Although there was no change in patient conditions, given the adverse effects associated with NBDs and DTAs these changes suggest a shift toward safer drug treatment practices."

Journal • CNS Disorders

Effects of Lemborexant on Insomnia and Its Relationship to Mood and Behavior on Opioid Use Disorder Subjects (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Virginia Commonwealth University | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Insomnia • Sleep Disorder • Substance Abuse

Comparative efficacy and safety of daridorexant, lemborexant, and suvorexant for insomnia: a systematic review and network meta-analysis. (PubMed, Transl Psychiatry) - "Considering that there is no evidence that DORAs are associated with physiological tolerance, withdrawal symptoms, or rebound insomnia when abruptly discontinued, and that sleep architecture is not adversely affected, the DORAs appear to be a favorable choice in managing insomnia disorder in adults."

Clinical • Journal • Retrospective data • Review • CNS Disorders • Infectious Disease • Insomnia • Pain • Respiratory Diseases • Sleep Disorder

Effect of lemborexant on sleep-wake state discrepancy in participants with insomnia disorder. (PubMed, Psychopharmacology (Berl)) - "The present findings suggest that lemborexant treatment reduces sleep-wake state discrepancy, which may be associated with improved daytime functioning in patients with insomnia disorder."

Journal • CNS Disorders • Insomnia • Sleep Disorder

Global burden of insomnia medication-associated suicidality, 1967-2024: A disproportionality analysis of the global pharmacovigilance database. (PubMed, Psychiatry Res) - "Although this disproportionality analysis did not permit causal interpretation, our study highlights significant variations in suicidality signal risk among insomnia medications, with benzodiazepines, Z-drugs, antidepressants, and first-generation H1 antagonists posing stronger signal, and dual orexin receptor antagonists presenting a weaker signal. Given the limitations of pharmacovigilance data, further studies are needed to confirm these findings and guide safer prescribing practices, particularly for individuals at high risk of suicidality."

Adverse events • Journal • CNS Disorders • Insomnia • Sleep Disorder

The putative effects of orexin receptor antagonists on pain and sleep in humans: A systematic review. (PubMed, Sleep Med) - "Orexin receptor antagonists improve sleep, but due to the very limited number of studies and small sample sizes, evidence regarding analgesic effects in humans remains inconclusive. The lack of receptor-selective interventions, short treatment durations, and pain condition variability may contribute to these findings. Future trials should investigate mechanistic analgesic effects, receptor-specific therapies, and explore orexin's role in pain phenotypes."

Journal • Review • CNS Disorders • Fibromyalgia • Insomnia • Musculoskeletal Pain • Pain • Rheumatology • Sleep Disorder

Efficacy of Ramelteon, Suvorexant, and Lemborexant for Delirium Prevention in Hospitalized Patients: A Systematic Review and Meta-Analysis. (PubMed, Crit Care Med) - "Sleep-wake regulating pharmacologic agents were associated with 40%-46% relative risk reductions in delirium prevalence, based on low-certainty evidence. Although these findings are promising, the absence of credible subgroup effects limits conclusions about the comparative efficacy of individual agents. Further, high-quality, prospective trials are needed to confirm these results and to clarify the role of specific pharmacologic strategies in delirium prevention."

Journal • Retrospective data • CNS Disorders

Prescription pattern and medical expenses in executive psychiatric clinic - RSUD Dr. Chasbullah Abdulmadjid (Type B government hospital) Bekasi City Indonesia - period March – November 2024 (CINP-AsCNP 2025) - "The most commonly prescribed medications were antidepressants (Vortioxetine, Escitalopram, Fluvoxamine, Mirtazapine, Duloxetine), antipsychotics (Brexpiprazole, Cariprazine, Aripiprazole, Quetiapine IR, Sulpiride) and non-benzodiazepines (Lemborexant). The coverage expenses for Psychiatric Clinic Type B Hospital with Indonesian national health insurance using Indonesia Case Base Groups (INA-CBGs) per month is 196.100 IDR / 12 USD / 20 AUD for consultation and medications (7 days to hospital) and the rest 23 days is fee for service. In comparison, the expenses at Executive Psychiatric Clinic Type B Government Hospital Bekasi City Indonesia are five times higher than national health insurance could cover to the hospital. And indeed each payment system has its own advantages and disadvantages."

Clinical • CNS Disorders • Depression • Insomnia • Mood Disorders • Psychiatry • Schizophrenia • Sleep Disorder

Sex Differences in Adverse Events Reported With Concomitant Buprenorphine and Insomnia Medications Use (CPDD 2025) - "Secondary search terms included commonly prescribed medications for insomnia: “temazepam”, “triazolam”, “estazolam”, “lorazepam”, “clonazepam”, “alprazolam”, “ramelteon”, “doxepin”, “trazodone”, “mirtazapine”, “suvorexant”, “lemborexant”, “daridorexant”, “quetiapine”, “hydroxyzine”, “gabapentin”, “eszopiclone”, “zaleplon”, “zolpidem”, “zolpidem ER”. Contrary to previous research demonstrating that females are involved in more AE reports across pharmacovigilance databases (Brabete et al., 2022), and that females taking 1 buprenorphine had an increased likelihood of insomnia medications prescription receipt, compared to their male counterparts (Martin et al., 2023), we did not find sex differences in the number of AE reports. However, the data suggest that males taking concomitant buprenorphine and insomnia medications, specifically benzodiazepines and DORAs, may experience more serious AEs than females."

Adverse events • CNS Disorders • Insomnia • Sleep Disorder

Impact of lemborexant on daytime sleepiness/alertness in participants with comorbid insomnia and mild obstructive sleep apnea (CNSF 2025) - No abstract available

CNS Disorders • Insomnia • Obstructive Sleep Apnea • Sleep Disorder

Consistency of objective sleep maintenance data in Chinese and North American/European subjects with insomnia in lemborexant phase 3 studies (CNSF 2025) - No abstract available

Clinical • P3 data • CNS Disorders • Insomnia • Sleep Disorder

A new direction for adjunctive therapy of difficult-to-treat depression: examining the role of orexin receptor antagonists. (PubMed, Eur Arch Psychiatry Clin Neurosci) - "Although it is likely that the currently approved Dual Orexin Receptor Antagonists (DORAs)-suvorexant, lemborexant and daridorexant-are safe and useful options for concomitant therapy of insomnia in antidepressant-treated patients, these medications have not been approved for this indication. By contrast, the investigational ORA seltorexant, which is a selective Orexin 2 receptor antagonist, has shown significant antidepressant effects in Phase 2 and Phase 3 trials. Although at least one more unequivocally positive pivotal study will be needed to garner FDA approval for clinical use in the United States, this drug shows promise as a novel and well-tolerated option for patients with difficult to treat depressive episodes."

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

Regulation of the gut-brain-pituitary-gonad axis in tilapia: Evidence for the involvement of orexin. (PubMed, Neuropeptides) - "The administration of either 0.1 or 1 mg orexin antagonist lemborexant (LBX) for 21 days led to a dose-dependent significant reduction in food intake, whereas a significant increase in the numbers of spermatogenic cells was observed in a high-dose LBX-treated group compared to the control fish...Overall, these findings suggest that blockade of orexin receptors by LBX promotes the spermatogenesis process. This effect might be mediated via the stimulation of 11-KT and androgen receptors at the testicular level and the GnRH-LH pathway at the hypothalamic-pituitary level in tilapia."

Journal • AR

Lemborexant ameliorates tau-mediated sleep loss and neurodegeneration in males in a mouse model of tauopathy. (PubMed, Nat Neurosci) - "Furthermore, both genetic ablation of orexin receptor 2 and lemborexant treatment reduced wakefulness and decreased seeding and spreading of phosphorylated tau in the brain of wild-type mice. These findings raise the therapeutic potential of targeting sleep by orexin receptor antagonism to prevent abnormal tau phosphorylation and limit tau-induced damage."

Journal • Preclinical • Alzheimer's Disease • CNS Disorders • Sleep Disorder

New Drug Approval for In-House Developed Anti-Insomnia Drug DAYVIGO (Lemborexant) in China (Eisai Press Release) - "Eisai Co., Ltd...announced today that the in-house discovered and developed orexin receptor antagonist DAYVIGO...has been approved in China for the treatment of adults with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. Eisai plans to launch this medicine in China in the second quarter of fiscal year 2025....Eisai submitted an application for approval, which was accepted in January 2024, based on the outcome of two pivotal Phase 3 clinical studies (SUNRISE 1: NCT02783729 and SUNRISE 2: NCT02952820) conducted globally in a total of approximately 2,000 adult patients with insomnia, as well as the outcome of a Phase 3 clinical study (Study 311: NCT04549168) conducted in China."

China approval • Insomnia

Effects of Lemborexant on Insomnia and Its Relationship to Mood and Behavior on Opioid Use Disorder Subjects (clinicaltrials.gov) - P2 | N=100 | Not yet recruiting | Sponsor: Virginia Commonwealth University

New P2 trial • CNS Disorders • Insomnia • Sleep Disorder • Substance Abuse

Treatment Patterns for Sleep Disorders in the United States Veterans Affairs Healthcare System (ISPOR 2025) - "Other treatments may include the melatonin receptor agonist (ramelteon) or sedating antidepressants (trazodone, off label)...Overall, an estimated 2.6% were prescribed zolpidem, 0.7% temazepam, 0.28% eszopiclone, 0.12% ramelteon, 0.06% zaleplon, 0.05% suvorexant, 0.04% triazolam, 0.006% lemborexant, 0.005% estazolam, and 0.001% daridorexant... The Z-drug zolpidem was the most commonly prescribed medication indicated for insomnia. Sedative antidepressants were also frequently utilized, likely due to their affordability and the lack of widely accepted, cost-effective alternatives for managing insomnia. Lemborexant and daridorexant, more recently approved for insomnia, were prescribed less frequently and have not yet become mainstream frontline treatments."

CNS Disorders • Insomnia • Sleep Disorder