To investigate effects on combination use of Ramelteon in the dose reduction or interruption process of (non-)BZD hypnotics during the dose reduction or interruption algorithm.
The hypnotic 'Ramelteon' does not have effect on Gamma Aminobutyric Acid (GABA-A) receptor that relates to the formation of addiction to the BZD or non-BZD hypnotics. Some results of clinical trials has been reported that the dose reduction or interruption of (non-)BZD hypnotics was achieved on combination use of Ramelteon by using its characteristic of the action mechanism with safely and effectively. However, these results have not been confirmed with randomized controlled trials.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
17
Ramelteon 8mg once daily before bedtime for 12 weeks since informed consent
Placebo capsule once daily before bedtime for 12 weeks since informed consent
Yoyogi Sleep Disorder Clinic, Foundation of Sleep and Health Science
Shibuya-ku, Tokyo, Japan
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.
Evaluate the achievement ratio of the 50% or more of dose reduction by Participant's diary
Time frame: 12 weeks
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.
The rate of subjects who achieved more than 50% of dose reduction (Diazepam conversion value) will be assessed by Participant's diary
Time frame: 12 weeks
The achievement ratio of the 50% dose reduction (Diazepam conversion value) at 4weeks and 8weeks
The rate of subjects who achieved more than 50% dose reduction (Diazepam conversion value) will be assessed by Participant's diary
Time frame: at 4 weeks and 8weeks
The average of the dose reduction rate at 4weeks, 8weeks and 12weeks
The average of the dose reduction rate will be assessed by Participant's diary
Time frame: at 4 weeks, 8weeks and 12 weeks
The achievement ratio of the 100% dose reduction at 12weeks or withdrawal
The achievement ratio of the 100% dose reduction will be assessed by Participant's diary
Time frame: 12 weeks
The variation in total score of Pittsburg Sleep Quality Index (PSQI) at 4weeks, 8weeks and 12weeks
The variation in total score of PSQI will be assessed by the PSQI value sets sets at week 0, 4, 8 and 12. (The range of total score is 0-21. Higher scores represent worse tendency of the symptoms.)
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Time frame: at 0, 4, 8 and 12 weeks
The variation in total score of Athens Insomnia Scale (AIS) at 4weeks, 8weeks and 12weeks
The variation in total score of AIS will be assessed by the AIS value sets at week 0, 4, 8 and 12. (The range of total score is 0-24. Higher scores represent worse tendency of the symptoms.)
Time frame: at 0, 4, 8 and 12 weeks
The variation in Patient health questionnaire (PHQ-9) score at 4weeks, 8weeks and 12weeks
The variation in PHQ-9 score will be assessed by the PHQ-9 value sets at week 0, 4, 8 and 12. (The range of total score is 0-27. Higher scores represent worse tendency of the symptoms.)
Time frame: at 0, 4, 8 and 12 weeks
Guide to the use of the clinical withdrawal assessment scale for benzodiazepines (CIWA-B) score at 4weeks, 8weeks and 12weeks
The variation in CIWA-B (Guide to the use of the clinical withdrawal assessment scale for benzodiazepines) score will be assessed by the CIWA-B value sets at week 4, 8 and 12. (The range of total score is 0-80. Higher scores represent worse tendency of the symptoms.)
Time frame: at 4, 8 and 12 weeks
Patient global impression of therapy (PGI) score at 12weeks or withdrawal
PGI(Patient global impression of therapy) score will be assessed by the PGI value sets at 12weeks or withdrawal. (The range of total score is 0-21. Higher scores represent worse tendency of the symptoms.)
Time frame: 12 weeks
The variation in Ben-dep(Benzodiazepine Dependence Self-Report Questionnaire) score at 12weeks or withdrawal
The variation in Ben-dep score will be assessed by the Ben-dep value sets at 0 and 12weeks or withdrawal. (The range of total score is 0-100. Higher scores represent worse tendency of the symptoms.)
Time frame: at 0 and 12 weeks
Adverse Events
Adverse Events will be determined by the latest version of MedDRA/J (Medical Dictionary for Regulatory Activities/J).
Time frame: 12 weeks