Chronic insomnia
Conditions
Interventions
Co-administer following medication for 12 weeks since informed consent
R group: taking capsule of Ramelteon 8mg once daily before sleeping.
Co-administer following medication for 12 weeks since informed consent
PL group: taking capsule of Placebo once daily before sleeping.
Sponsors
Yoyogi Sleep Disorder Clinic Foundation of Sleep and Health Science
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects meeting Criteria 1 or 2 and Criteria 3 and all subsequent criteria will be included in the study: 1. Patients diagnosed as chronic insomnia having sleep onset disturbance, and with a duration of the disease of at least 6 months 2. Patients diagnosed with chronic insomnia comorbid with mood disorders (depression or bipolar disorder) can be included to this study if they have remission of mood symptoms. 3. Patients taking (non-)BZD hypnotics (including etizolam at bedtime) at a fixed dose in the following patterns since at least 1 month prior to consent (over 90% of drug compliance should be confirmed at the time of medical interview): * Patients taking 2 drugs at the usual dose (1 unit) *Patients taking 3 drugs at the usual dose (1 unit) * Patients taking 4 drugs at the usual dose (1 unit) * Patients taking a drug at 2-fold of the usual dose (2 units) * Patients taking a drug at 2-fold of the usual dose (2 units) and a drug at the usual dose (1 unit) * Patients taking a drug at 2-fold of the usual dose (2 units) and 2 drugs at the usual dose (1 unit) * Patients taking 2 drugs at 2-fold of the usual dose (2 units) 4. Patients whoes symptoms of insomnia were stabilized, and the investigators determined that the (non-) BZD hypnotics could be reduced or discontinued 5. Patients aged 20 years or older at the time of consent 6. Patients who are willing to comply with algorithm for dose reduction and discontinuation 7. Patients who can understand the content of the study and provide consent to participate in the study in writing on their own will.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The achievement ratio of the 50% dose reduction of (non-)BZD hypnotics (Diazepam conversion value) at 12weeks or withdrawal without any deterioration of insomnia symptoms The rate of subjects who achieved more than 50% dose reduction of (non-)BZD hypnotics (Diazepam conversion value) at 12 weeks or withdrawal since informed consent. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) The achievement ratio of the 50% dose reduction (Diazepam conversion value) at 4weeks and 8weeks 2) The average of the dose reduction rate at 4weeks, 8weeks and 12weeks 3) The achievement ratio of the 100% dose reduction at 12weeks or withdrawal 4) The variation in total score of PSQI and AIS at 4weeks, 8weeks and 12weeks 5) The variation in PHQ-9 score at 4weeks, 8weeks and 12weeks 6) CIWA-B score at 4weeks, 8weeks and 12weeks 7) PGI score at 12weeks or withdrawal | — |
Countries
Japan
Contacts
Public ContactMina Kobayashi
Yoyogi Sleep Disorder Clinic No
Outcome results
None listed