臨床研究等提出・公開システム

Date of registration	Sept. 11, 2026
Last modified on	Sept. 11, 2026
Trial ID	jRCT1031260489

Scientific Title	Efficacy of Dual Orexin Receptor Antagonists in Hypnotic-Naive Patients with Insomnia
Public Title	Efficacy of Dual Orexin Receptor Antagonists in Hypnotic-Naive Patients with Insomnia

Contact for Scientific Queries	Name	HIROTA SUSUMU
	Affiliation	Hirota Clinic
	Address	45-2 tenjinmachi kurume fukuoka japan
	Telephone	+81-942372595
	E-mail	ponhiro21@yahoo.co.jp
Contact for Public Queries	Name	Hirota Susumu
	Affiliation	Hirota Clinic
	Address	45-2 tenjinmachi kurume fukuoka japan
	Telephone	+81-942372595
	E-mail	ponhiro21@yahoo.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		April. 01, 2018
Actual date of first enrollment		April. 01, 2018
Target sample size		400
Study Type		Observational
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	New patients aged >18 years who were diagnosed with insomnia, had no prior history of hypnotic treatment, and received suvorexant or lemborexant for the first time.
	Exclusion Criteria	1. Patients who received suvorexant (SUV) or lemborexant (LEM) in a manner inconsistent with the approved prescribing information. 2. Patients with any contraindication to SUV or LEM. 3. Patients who regularly used sedating antidepressants (mirtazapine, mianserin, or trazodone) or antipsychotics (immediate-release quetiapine, extended-release quetiapine, olanzapine, risperidone, asenapine, or typical antipsychotics) after dinner or at bedtime during treatment with SUV or LEM. 4. Patients with a history of hypnotic use. 5. Patients with specific sleep disorders other than insomnia, such as periodic limb movement disorder, restless legs syndrome, or circadian rhythm sleep-wake disorders. 6. Patients with narcolepsy or cataplexy. 7. Patients who declined participation in the study through the opt-out process.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Insomnia
Health Condition(s) Keyword		insomnia orexin hypnotics
Intervention(s) Keyword		orexin receptor antagonist dual orexin receptor antagonist benzodiazepine receptor agonist
Primary Outcome(s)		Clinical Improvement Rate after 52 Weeks of DORA Treatment
Secondary Outcome(s)		Switching Rates to Other Hypnotics among Patients Who Discontinued DORAs, SUV, or LEM 52-Week Continuation Rates of DORAs, SUV, and LEM by Comorbidity 52-Week Discontinuation Rates Due to Improvement with DORAs, SUV, and LEM by Comorbidity Improvement Rates with DORAs in Non-Elderly and Elderly Patients

Primary Sponsor	none

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Research Ethics Committee, Japan Association of Psychiatric Clinics
Address	Miyata Building 7F, 1-38-2 Yoyogi, Shibuya-ku, Tokyo, Japan, Tokyo
Telephone	+81-3-3320-1423
E-Mail	office@japc.or.jp
Approval Status	Approval
Date of approval	Dec. 23, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none