Dayvigo (lemborexant) / Eisai - LARVOL DELTA

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

New P2 trial • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Apnea • Sleep Disorder

Efficacy and safety of lemborexant vs placebo in treating adults with insomnia disorder: a systematic review and meta-analysis of 1976 patients. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "Both formulations of 5-mg and 10-mg doses were well tolerated with no significant difference in their effect; however, somnolence was more common relative to placebo. Lemborexant appears to fill a therapeutic gap in the treatment of insomnia but should be used with caution and smaller dose (5 mg) in those who are at risk of developing an excessive daytime somnolence state."

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

Perception of Lemborexant Effectiveness as Assessed by the Patient Global Impression-Insomnia Questionnaire. (PubMed, Nat Sci Sleep) - "For sTST (in minutes) at 6 months, mean CFB tended to be greater for subjects reporting positive (LEM5=81.2, LEM10=93.2, PBO=74.8; LEM5 vs PBO, p=0.28; LEM10 vs PBO, p=0.18) versus negative (LEM5=46.4, LEM10=35.0, PBO=38.6; LEM5 vs PBO, p=0.44; LEM10 vs PBO, p=0.52) effects, although this was not statistically significant. Patient impressions of the effects of lemborexant were positive based on the PGI-I and reflected improvements in subjective sleep outcome measures, indicating that the brief PGI-I tool may be useful in clinical practice."

Journal • CNS Disorders • Insomnia • Sleep Disorder

Efficacy of CBT-I and Lemborexant Medication for Different Subtypes of Chronic Insomnia (clinicaltrials.gov) - P=N/A | N=90 | Recruiting | Sponsor: Laval University | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Insomnia • Sleep Disorder

Efficacy and Safety of Lemborexant Versus Placebo in Treating Adults with Insomnia Disorder: A Systematic Review and Meta-Analysis of 1,976 Patients (P12-4.006). (PubMed, Neurology) - "Serag has nothing to disclose. Disclaimer: Abstracts were not reviewed by Neurology® and do not reflect the views of Neurology® editors or staff."

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

Impact of Lemborexant on Daytime Sleepiness/Alertness in Participants With Comorbid Insomnia and Mild Obstructive Sleep Apnea (P9-4.004). (PubMed, Neurology) - P3 | "Boulos has received personal compensation in the range of $5,000-$9,999 for serving as a speaker with Jazz Pharmaceuticals. Disclaimer: Abstracts were not reviewed by Neurology® and do not reflect the views of Neurology® editors or staff."

Clinical • Journal • Alzheimer's Disease • Cardiovascular • CNS Disorders • Cognitive Disorders • Insomnia • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

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 | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Insomnia • Sleep Disorder

Efficacy and safety of Lemborexant in treating adult patients with insomnia in China: a single-center, retrospective observational study. (PubMed, Front Neurol) - "No patient discontinued the treatment due to TEAE(s). Lemborexant treatment was effective and safe in treating a wide variety of Chinese patients with different symptom(s) of insomnia."

Journal • Observational data • Retrospective data • CNS Disorders • General Anxiety Disorder • Insomnia • Mood Disorders • Psychiatry • 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

EISAI TO PRESENT LECANEMAB REAL-WORLD EXPERIENCE DATA AND FINDINGS FROM NEUROLOGY PORTFOLIO AT THE AMERICAN ACADEMY OF NEUROLOGY (AAN) ANNUAL MEETING (PRNewswire) - "Eisai Inc. announced today that the company will present the latest findings from its robust neurology portfolio, including data on real-world experience and continued maintenance dosing with our dual-acting, anti-amyloid beta (Aβ) protofibril antibody for the treatment of Alzheimer's disease (AD), lecanemab (generic name, U.S. brand name: LEQEMBI) at the American Academy of Neurology (AAN) Annual Meeting, being held in San Diego, California, and virtually from April 5-9. Eisai will present two (2) oral presentations and seven (7) posters on lecanemab and the insomnia dual orexin receptor antagonist DAYVIGO (lemborexant) CIV."

Clinical data • Alzheimer's Disease • Insomnia • Obstructive Sleep Apnea

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

Eisai DSPS: Lemborexant in Delayed Sleep Phase Syndrome (clinicaltrials.gov) - P4 | N=15 | Recruiting | Sponsor: University of California, San Francisco

New P4 trial • Delayed Sleep Phase Disorder

Impact of Postoperative Sleep Medication Use on 90-Day Complications Following Total Knee Arthroplasty (AAOS 2025) - "We further analyzed the effects of standard prescription sleep medications (Daridorexant, Eszopiclone, Lemborexant, Suvorexant, Temazepam, Triazolam, Zaleplon, Zolpidem) and less potent prescription sleep medications (Doxepin, Ramelteon). Both standard and less potent prescription sleep medication use is associated with surgical complications. Post-operative sleep disturbance remains a major problem following TKA, but prescription sleep medications may be unsafe for routine postoperative use."

Insomnia • Musculoskeletal Diseases • Orthopedics • Pain • Sleep Disorder

Impact of Lemborexant on Daytime Sleepiness/Alertness in Participants With Comorbid Insomnia and Mild Obstructive Sleep Apnea (AAN 2025) - P3 | "While the sample size was too small to detect statistical differences, a greater percentage of participants with COMISA experienced improvements in morning sleepiness across the treatment period with LEM versus PBO. These data align with previous findings that LEM does not affect tasks requiring morning alertness."

Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Insomnia • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Efficacy and Safety of Lemborexant Versus Placebo in Treating Adults with Insomnia Disorder: A Systematic Review and Meta-Analysis of 1,976 Patients (AAN 2025) - "Meta-analysis found that Lemborexant is an effective pharmacotherapy for the treatment of insomnia as it improves sleep onset latency, wake after sleep onset and sleep efficiency. Both formulations of 5 mg and 10 mg doses were well tolerated with no significant difference in their effect, however somnolence was more common relative to placebo. Lemborexant appears to fill a therapeutic gap in the treatment of insomnia but should be used with care and smaller dose (5 mg) in those who are at risk of developing an excessive day time somnolence state."

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

Safety of dual orexin receptor antagonists: a real-world pharmacovigilance study. (PubMed, Expert Opin Drug Saf) - "Data related to daridorexant, suvorexant, and lemborexant were collected from the US Food and Drug Administration Adverse Event Reporting System between the first quarter of 2022 and the third quarter of 2024. The analysis of disproportionality signals may prompt increased awareness of toxicities for DORAs. The results of serious reports and dosage of drugs provided supporting evidence for clinicians to manage AEs."

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

Lemborexant for the Treatment of Residual Insomnia in Major Depressive Disorder (MDD) (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Unity Health Toronto

New P2 trial • CNS Disorders • Depression • Insomnia • Major Depressive Disorder • Mental Retardation • Mood Disorders • Psychiatry • Sleep Disorder

LOSALAT: Effects of Lemborexant as a Treatment for Moderate-to-severe OSA Patients With Low Arousal Threshold (clinicaltrials.gov) - P1/2 | N=10 | Recruiting | Sponsor: Chulalongkorn University | N=20 ➔ 10

Enrollment change

Response to "Letter to the editor regarding 'Effect of lemborexant on sleep architecture in participants with insomnia disorder and mild obstructive sleep apnea' by Kushida et al.". (PubMed, Sleep Med) - No abstract available

Journal • CNS Disorders • Insomnia • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

L'ÉTOILE: Lemborexant Treatment of Insomnia Linked to Epilepsy (clinicaltrials.gov) - P3 | N=26 | Recruiting | Sponsor: University of Manitoba | Trial completion date: Apr 2026 ➔ Apr 2027 | Trial primary completion date: Apr 2025 ➔ Apr 2026

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

Letter to the editor regarding "Effect of lemborexant on sleep architecture in participants with insomnia disorder and mild obstructive sleep apnea" by Kushida et al. (PubMed, Sleep Med) - No abstract available

Journal • CNS Disorders • Insomnia • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

MR Imaging Indices for Brain Interstitial Fluid Dynamics and the Effects of Orexin Antagonists on Sleep. (PubMed, Magn Reson Med Sci) - "Our results suggested that poor sleep status is related to the greater change of ALPS-index and CPV improvement after lemborexant administration may be related to in part to sleep parameter improvement."

Journal • CNS Disorders • Sleep Disorder

Neuro-DORA: A Dual Orexin Receptor Antagonist to Reduce Biomarkers of Neurodegeneration in Adults with Insomnia. (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: Woolcock Institute of Medical Research

New P2 trial • CNS Disorders • Insomnia • Sleep Disorder • p-tau181

A Study to Assess the Pregnancy Outcome in Women Exposed to Dayvigo® During Pregnancy Compared to an Unexposed Control Population (clinicaltrials.gov) - P=N/A | N=861 | Active, not recruiting | Sponsor: Eisai Inc. | Not yet recruiting ➔ Active, not recruiting

Enrollment closed

Effect of lemborexant on sleep architecture in participants with insomnia disorder and mild obstructive sleep apnea. (PubMed, Sleep Med) - P3 | "LEM significantly increased TST in participants with insomnia and mild OSA. Importantly, REM sleep, associated with cognitive performance, increased. These data support the use of LEM in patients with insomnia and mild OSA."

Journal • CNS Disorders • Insomnia • Obstructive Sleep Apnea • Psychiatry • Respiratory Diseases • Sleep Disorder