The placebo controlled randomized double blind multicenter study to investigate effectiveness and safety of combination use of melatonin receptor agonist for dose reduction or interruptions of BZD and non-BZD hypnotics on chronic insomnia.

Not Applicable

• Conditions: Chronic insomnia

• Registration Number: JPRN-UMIN000026332
• Lead Sponsor: Yoyogi Sleep Disorder Clinic Foundation of Sleep and Health Science

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-02-28
• Study Completion: 2019-07-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

Exclusion Criteria

Subjects meeting any of the following criteria will not be included in the study: 1. Patients with secondary insomnia 2. Patients taking (non-)BZD hypnotics at a dose exceeding 2-fold of the usual dose 3. Patients taking barbiturate and non-barbiturate hypnotics and Suvorexant. 4. Patients taking hypnotics other than medicinal pharmaceuticals (including OTC, supplements believed to be effective for insomnia and melatonin) 5. Patients taking mianserin hydrochloride, mirtazapine, and trazodone hydrochloride 6. Patients taking antipsychotics 7. Patients taking anxiolytic or clonazepam at bedtime *Patient taking anxiolytic and/or clonazepam at times except for bed-time will be included in the study. However, dosage and timing of administration can not be changed during the study period. 8. Patients who took ramelteon within 1 month prior to the informed consent 9. Patients in whom the dose of psychotropics except for the items 2-7 were changed within 1 month prior to the informed consent 10. Patients who are comorbid with depression or bipolar disordeand and in whom depressive symptoms have not remitted 11. Patients in whom frequency in Q9 of PHQ "thoughts that you would be better off dead or thoughts of hurting yourself in some way" is "more than half the days (in the past 2 weeks)" or the total score is 10 or higher 12. Patients with dementia, schizophrenia, drug dependence and alcoholic 13. Patients with liver/kidney disorder, female subjects who are pregnant or in breast-feeding, and malignant neoplasm 14. Night workers 15. Patients meeting contraindications for ramelteon 16. Other patients judged ineligible for participation in the study by the investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified