Tokyo, March 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061048) titled 'Head to Head Comparison of Vorzzz and Dayvigo in the Treatment of Insomnia' on March 25.

Study Type: Observational

Primary Sponsor: Institute - RESM Shin-Yokohama respiratory and sleep medical-care clinic

Condition: Condition - Insomnia Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to evaluate changes in sleep-related parameters (such as subjective and objective sleep assessment scores) following administration of Vornorexant (Vorzzz) or lemborexant (Dayvigo) in patients with insomnia excluding sleep apnea syndrome, and to assess their efficacy and safety in a real-world clinical setting. Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1) Patients with an AHI of less than 10 events per hour based on overnight polysomnography (PSG) testing 2)Individuals diagnosed with insomnia according to the ICSD-3 diagnostic criteria 3)Individuals who consent to administration of Vornorexant (Vorzzz) (*) 4) Individuals who consent to administration of Lemborexant (Dayvigo) (*) 5) Patients deemed necessary by the outpatient physician *; Only one medication will be prescribed. Key exclusion criteria - Patients unwilling to participate in this study Patients unwilling to undergo PSG testing Severe hepatic impairment (Child-Pugh class C) History of hypersensitivity to any component of Vornorexant (Vorzzz) History of hypersensitivity to any component of Lemborexant (Dayvigo) Pregnant or breastfeeding women Individuals unable to complete questionnaires due to cognitive impairment or other reasons Other patients deemed unsuitable for the study by the principal investigator Target Size - 50

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 02 Month 04 Day Date of IRB - 2026 Year 02 Month 04 Day Anticipated trial start date - 2026 Year 03 Month 04 Day Last follow-up date - 2030 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069374

Disclaimer: Curated by HT Syndication.