Head to Head Comparison of Vorzzz and Dayvigo in the Treatment of Insomnia

Real World Efficacy and Safety of Vornorexant versus Lemborexant in Patients with Insomnia: A Prospective Observational Study - Real World Efficacy and Safety of Vornorexant versus Lemborexant in Patients with Insomnia: A Prospective Observational Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000061048

Enrollment

Registered

2026-03-25

Start date

2026-03-04

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Sleep Log (52 weeks after drug administration) Subjective sleep latency	—

Secondary

Measure	Time frame
Sleep Diary (Week 52 after drug administration) Subjective WASO (Wake After Sleep Onset), total sleep time, sleep efficiency Athens Insomnia Scale (Week 52 after drug administration) Sleep indices from the Kissei Activity Monitor (SleepSign-Act Ver.2.0, FS-770), morning alertness (activity levels from wake-up to 1 hour, from 1 to 2 hours, and from 3 to 4 hours after waking), and daytime activity indices (e.g., daytime calorie expenditure) (at each evaluation point) Sleep depth and other sleep indicators obtained from Kenko Ai Ring (Kai-01, KenkoAi Co., Ltd.) Information obtained during routine medical care (heart rate, sleep diary, Athens Insomnia Scale, Karolinska Sleepiness Scale (KSS), Pittsburgh Sleep Quality Index (PSQI), Restorative Sleep Questionnaire (RSQ) Japanese version, etc.), medication safety, hyperarousal assessment (Hyperarousal Scale Japanese version (HAS-J), Japanese version of the Pre-Sleep Arousal Scale (PSAS), etc.), Ford Insomnia Response to Stress Test (FIRST), Japanese version of the Insomnia Catastrophizing Scale (ICS), dysfunctional beliefs and attitudes about sleep (DBAS), Montreal Cognitive Assessment (MoCA), Kissei activity monitor (SleepSign-Act Ver.2.0, FS-770), Kenko Ai Ring (Kai-01, KenkoAi Co., Ltd.) sleep indices and daytime activity indices) (at each assessment point), side effects and safety	—

Measure

Time frame

Sleep Diary (Week 52 after drug administration) Subjective WASO (Wake After Sleep Onset), total sleep time, sleep efficiency Athens Insomnia Scale (Week 52 after drug administration) Sleep indices from the Kissei Activity Monitor (SleepSign-Act Ver.2.0, FS-770), morning alertness (activity levels from wake-up to 1 hour, from 1 to 2 hours, and from 3 to 4 hours after waking), and daytime activity indices (e.g., daytime calorie expenditure) (at each evaluation point) Sleep depth and other sleep indicators obtained from Kenko Ai Ring (Kai-01, KenkoAi Co., Ltd.) Information obtained during routine medical care (heart rate, sleep diary, Athens Insomnia Scale, Karolinska Sleepiness Scale (KSS), Pittsburgh Sleep Quality Index (PSQI), Restorative Sleep Questionnaire (RSQ) Japanese version, etc.), medication safety, hyperarousal assessment (Hyperarousal Scale Japanese version (HAS-J), Japanese version of the Pre-Sleep Arousal Scale (PSAS), etc.), Ford Insomnia Response to Stress Test (FIRST), Japanese version of the Insomnia Catastrophizing Scale (ICS), dysfunctional beliefs and attitudes about sleep (DBAS), Montreal Cognitive Assessment (MoCA), Kissei activity monitor (SleepSign-Act Ver.2.0, FS-770), Kenko Ai Ring (Kai-01, KenkoAi Co., Ltd.) sleep indices and daytime activity indices) (at each assessment point), side effects and safety

—

Countries

Japan

Contacts

Public ContactRyutaro Shirahama

RESM Shin-Yokohama respiratory and sleep medical-care clinic Internal Medicine

shirahama.r@resm.info045-475-5155

Outcome results