Dayvigo (lemborexant) / Eisai - LARVOL DELTA

Lemborexant overdose presenting with mild sedation despite high plasma levels: A case report. (PubMed, Toxicol Rep) - "A 33-year-old woman presented to the emergency department four hours after ingesting an estimated 720 mg of lemborexant and 78 mg of eszopiclone. This case suggests that massive lemborexant overdoses may not cause life-threatening toxicity even when plasma levels approach those reported in fatal cases. This case provides preliminary but clinically important data and highlights the need for further research to better characterize the clinical implications and management of lemborexant overdoses."

Journal • Anesthesia • CNS Disorders • Depression • Insomnia • Psychiatry • Sleep Disorder

Perioperative switching to lemborexant for prevention of delirium in older cancer patients with insomnia taking GABAA receptor agonists: a retrospective study. (PubMed, Support Care Cancer) - "A preoperative switch policy to lemborexant monotherapy was associated with a lower observed risk of POD. Given the observational, unadjusted design, these associations are hypothesis-generating and cannot establish causality."

Journal • Retrospective data • Anesthesia • CNS Disorders • Cognitive Disorders • Insomnia • Oncology • Sleep Disorder

A 12-Week, Open-Label, Multicenter Pilot Study to Evaluate the Efficacy and Safety of Lemborexant in Patients with Insomnia Comorbid with Depressive Episodes (SELENADE). (PubMed, CNS Drugs) - "Lemborexant was associated with improvements in insomnia severity and depressive symptoms related to MDD or BD, with no new safety concerns. It may be a treatment option for residual insomnia following treatment for depression associated with MDD or BD, though somnolence and nightmares warrant attention. Confirmatory studies are needed to establish its therapeutic value."

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

Current and novel dual orexin receptor antagonists for the treatment of insomnia: the emergence of vornorexant. (PubMed, Int J Neuropsychopharmacol) - "As an alternative target to generate novel hypnotics, the orexin system has recently gained much attention, and 3 dual orexin receptor antagonists (DORAs)-suvorexant, lemborexant, and daridorexant-were launched. Indeed, it has shown rapid sleep-promoting effects in patients with insomnia, maintaining its activity throughout the night but having a low incidence of next-day residual effects. In this review, we first provide an overview of the role of the orexin system in sleep/wake balance and then describe the profile of a newly developed DORA, vornorexant, from drug discovery to clinical results."

Journal • CNS Disorders • Insomnia • Sleep Disorder

Rest: a transformer-based model for automated mouse sleep stage classification (Neuroscience 2025) - "REST was subsequently used to score over 3,000 days of EEG/EMG data from CD-1 mice in a TBI study where TBI and sham groups were treated with an FDA approved sleep aid, Lemborexant or vehicle... REST is a fast, accurate, and consistent tool for automatic sleep staging in mice. Its Transformer architecture provides long-range temporal awareness and generalizes across mouse strains and models. REST enables scalable, unbiased, and reliable analysis of rodent sleep in large datasets."

Preclinical • CNS Disorders • Sleep Disorder • Vascular Neurology

Effects of dual orexin antagonist sleep-aid treatment on posttraumatic seizures and GABAergic inhibition (Neuroscience 2025) - "Animals also underwent EEG/EMG electrode implantation allowing continuous recordings for 6 weeks to record seizures and sleep, while being treated daily at 8 am via oral gavage with an FDA-approved DORA (Lemborexant, EISAI Inc) at 100mg/kg (or vehicle)...Analysis of mIPSCs is in progress. Our data thus far show that DORA treatment can suppress posttraumatic seizures and interictal spiking after TBI without altering GABAergic tonic inhibition in granule cells."

CNS Disorders • Epilepsy • Post-traumatic Stress Disorder • Psychiatry • Sleep Disorder • Vascular Neurology

Sleep Architecture Alterations Following High-Dose Steroid Pulse Therapy: A Pilot Study Using a Portable Electroencephalogram-Based Device. (PubMed, Neuropsychopharmacol Rep) - "These findings suggest that high-dose SPT can markedly reduce REM sleep. Moreover, portable EEG devices could be a practical approach for monitoring steroid-induced sleep alterations. Our findings provide clinical evidence that may help to deepen the objective understanding of sleep during SPT."

Journal • CNS Disorders • Insomnia • Sleep Disorder

Improving Quality Outcomes through a Medicine Hospitalist-Driven Malignant Hematology Service (ASH 2024) - "2020; 25(12) : e2006-e2009).To our knowledge, Moffitt Cancer Center pioneers one of the first long-term, consistent and comprehensive studies into the hospitalist model for inpatient care, focusing on individuals with malignant hematology conditions and addressing their acute medical issues...Severity of illness, age and risk of mortality increased significantly. There was no significant difference in unplanned readmission rate (Table 1).Conclusion : Significant ALOS reduction despite increased severity, age, and risk of mortality, and no change in unplanned readmission rates highlight the success of the co-managed Heme C and M hospitalist service in addressing acute medical problems and shaping future developments in inpatient malignant hematology programs."

Clinical • Palliative care

Efficacy of Lemborexant in Managing Multi-etiology Delirium. (PubMed, Am J Ther) - No abstract available

Journal • CNS Disorders

Dual orexin receptor antagonists in insomnia: Toward a new therapeutic paradigm. (PubMed, Pharmacol Biochem Behav) - "Although three dual orexin receptor antagonists (DORAs), suvorexant, lemborexant, and daridorexant, are currently available and widely used to treat insomnia, the differences in their elimination half-lives are not sufficient. However, several challenges remain to be addressed in order to fully realize the clinical potential of DORAs. This review identifies four key challenges requiring resolution to advance their optimal use in clinical practice."

Journal • CNS Disorders • Insomnia • Sleep Disorder

Successful Methods for Switching from a Benzodiazepine Receptor Agonist to a Dual Orexin Receptor Antagonist for the Treatment of Insomnias. (PubMed, Clin Psychopharmacol Neurosci) - "We performed a secondary analysis of our prior retrospective study of the rate of DORA (suvorexant or lemborexant) continuance at 3 months after the introduction of these agents in 210 patients under long-term BZRA treatment. The analyses identified higher BZRA dose at baseline (Exp(B): 1.801, 95% CI: 1.008-3.216) as a predictor of both DORA continuation and BZRA tapering. These findings suggest that in efforts to switch a patient's insomnia medication to a DORA, the tapering of ultra-short/short-acting BZRAs can lead to the successful switch to a DORA among patients under high-dose BZRA treatment, whereas careful switching is necessary for patients under long-term BZRA treatment."

Journal • CNS Disorders • Insomnia • Sleep Disorder

Neurofunctional phenotyping to investigate the role of the orexin system at the intersection of opioid use disorder and insomnia: a protocol for a randomised, placebo-controlled clinical trial of lemborexant in patients with insomnia receiving buprenorphine. (PubMed, BMJ Open) - P2 | "Results will also be shared with interested participants and clinical collaborators upon completion of the trial. NCT06981195."

Clinical • Clinical protocol • Journal • Addiction (Opioid and Alcohol) • CNS Disorders • Insomnia • Sleep Disorder • Substance Abuse

Efficacy and safety profiles of FDA-approved dual orexin receptor antagonists in depression: A systematic review of pre-clinical and clinical studies. (PubMed, J Psychiatr Res) - "DORAs show potential in improving sleep parameters in individuals with MDD. While their effects on depressive symptoms in this review are modest, further research is needed to assess long-term efficacy, safety, and their impact on depressive symptoms, as well as to explore potential combination therapies."

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

Self-reported sleep variables, sleep quality, and quality of life assessment in transition to lemborexant in patients with Insomnia: the multicenter, open-label SOMNUS study. (PubMed, Sleep Med X) - P4 | "The prospective, nonrandomized, open-label, multicenter SOMNUS Study analyzed data from 90 patients across four cohorts of direct switching to lemborexant from Z-drugs (monotherapy cohort: n = 25), suvorexant (monotherapy cohort: n = 25, combination cohort: n = 21), and ramelteon (combination cohort: n = 19) up to 14 weeks. These findings indicate that transitioning to lemborexant from previous insomnia treatment is efficacious in improving sleep parameters, insomnia severity, and health-related quality of life, with a favorable safety profile. NCT04742699."

HEOR • Journal • CNS Disorders • Insomnia • Sleep Disorder

Efficacy and safety of insomnia pharmacotherapies: Convergent evidence from Bayesian network meta-regression and FAERS-based disproportionality analysis. (PubMed, Sleep Med) - "Comprehensively considering the efficacy effect size, time windows (follow-up period, age, and types of insomnia), PV, severity of imperative adverse events, we propose prioritizing the use of daridorexant 25 mg/d for insomnia characterized by difficulty maintaining sleep and insufficient sleep duration. For insomnia characterized by difficulty falling asleep, we recommend prioritizing the use of lemborexant 10 mg/day or zolpidem 10 mg/day. For overall poor sleep efficiency, we recommend using lemborexant. Drug selection should be based on the types of insomnia and drug safety. More head-to-head clinical trials are needed to confirm those findings."

Journal • Review • CNS Disorders • Insomnia • Pulmonary Disease • Sleep Disorder

A bounded hierarchy framework for the evolution of syntax. (PubMed, Biol Philos) - "2018 in PLoS Biol 16(8):e2006425, 2018...Considering these problems, as well as empirical evidence of hierarchy in nonhuman animals, I provide an alternative framework for studying the evolution of human syntax, which I call "bounded hierarchy". The bounded hierarchy framework that I propose traces the evolutionary origins of human syntax to simpler forms of bounded hierarchy that may be present in extant nonhuman animals."

Journal

Effect of dual orexin receptor antagonists on sleep: A systematic review and meta analysis (ECNP 2025) - "The DORAs included were suvorexant, lemborexant, daridorexant, seltorexant, filorexant and vornorexant. Most DORAs were found to be of robust efficacy, irrespective of diagnosis, although further research is required for most diagnoses. Most DORAs seem to cause notably more somnolence than placebo, which is of great clinical importance."

Retrospective data • Review • Alzheimer's Disease • Bipolar Disorder • CNS Disorders • Depression • Insomnia • Major Depressive Disorder • Mood Disorders • Movement Disorders • Psychiatry • Restless Legs Syndrome • Sleep Disorder

Comprehensive understanding of the treatment of insomnia with lemborexant. (PubMed, Expert Rev Clin Pharmacol) - "Evidence supports its safe use in older adults and patients with obstructive sleep apnea or chronic obstructive pulmonary disease. Further research should address its role in psychiatric and medical comorbidities, and substance use disorders."

Journal • Review • Alzheimer's Disease • Chronic Obstructive Pulmonary Disease • CNS Disorders • Cognitive Disorders • Immunology • Insomnia • Obstructive Sleep Apnea • Psychiatry • Pulmonary Disease • Respiratory Diseases • Sleep Disorder

Potential Effectiveness of Yokukansan and Lemborexant as Alternative Candidates to Benzodiazepines to Prevent Benzodiazepine Withdrawal Delirium in the Cancer Perioperative Period: A Case Report and Literature Review. (PubMed, Neuropsychopharmacol Rep) - "The combination of yokukansan and lemborexant may be an effective replacement for benzodiazepines in terms of their effects on 5-hydroxytryptamine-related mechanisms and regulation of the sleep cycle. During the cancer perioperative period, physicians may consider the gradual replacement or reduction of benzodiazepines with yokukansan and lemborexant before the surgery to avoid possible benzodiazepine-related delirium."

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

Is bigger better? Analysis of efficacy and safety of lemborexant 5 versus 10 mg in insomnia patients. (PubMed, Int J Pharm Pract) - "Lemborexant 10 mg is generally not advisable as an initial or escalated dose due to higher harm risk and unlikely clinical benefit."

Journal • CNS Disorders • Insomnia • Sleep Disorder

Efficacy and safety of lemborexant in patients with insomnia: a systematic review and meta-analysis. (PubMed, Sleep Med) - "Lemborexant demonstrates significant efficacy in improving sleep parameters in patients with insomnia and has a generally favorable safety profile. These findings support its role as an effective pharmacological option. Further high-quality studies are needed to confirm its efficacy and safety."

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

Physiologically Based Pharmacokinetic Modeling of Lemborexant: Exploration of Doses for Populations with Hepatic Impairment. (PubMed, J Clin Pharmacol) - "Based on the changes in exposure, it is recommended that the maximum dose for populations with severe hepatic impairment should be limited to 5 mg once daily, which is similar to moderate hepatic impairment. The PBPK model can be used as a tool for dose adjustments in populations with hepatic impairment."

Journal • PK/PD data • CNS Disorders • Hepatology • Insomnia • Sleep Disorder

Effect of lemborexant on sleep parameters in moderate-to-severe OSA patients with low arousal threshold (ERS 2025) - "LEM in patients with moderate to severe OSA and low arousal threshold had no significant effect on AHI but a trend of NREM RDI reduction in moderate OSA. Lemborexant had significant increase in REM sleep and a trend towards improvement in vigilance. This highlights the importance of pharmacological therapy in OSA for optimizing sleep architecture and enhancing daytime alertness."

Clinical • Insomnia • Obstructive Sleep Apnea • Respiratory Diseases

A network meta-analysis of various pharmacotherapeutics for obstructive sleep apnea (ERS 2025) - "Conclusion Morning fluoxetine 10 mg + evening ondansetron 24 mg and tirzepatide 10 or 15 mg are the most promising drugs for reducing OSA severity. Lemborexant 10 mg improved sleep efficiency and architecture the most, whereas remifentanil 0.075 mg/kg disrupted them the most."

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

Patient-Reported Changes in Bipolar Disorder Treatment Perceptions in Japan: A 2015 and 2022 Survey Analysis (ISBD 2025) - "Lithium carbonate showed the greatest increase, more than doubling in 2022. Among hypnotics, the use of BZPs decreased, while newer agents like suvorexant and lemborexant gained higher ratings. The 2022 survey indicated an increased preference for medications with higher guideline recommendations, such as mood stabilizers and SGAs, while those recommended for cautious use, such as BZPs and antidepressants, were rated lower."

Clinical • Bipolar Disorder • CNS Disorders • Mood Disorders • Psychiatry