NCT03461042

The Study of Combination Use of Melatonin Receptor Agonist for Dose Reduction or Interruptions of Benzodiazepine (BZD) and Non-BZD Hypnotics on Chronic Insomnia

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Chronic Insomnia

Interventions

Type	Name	Description
DRUG	Ramelteon 8mg	Ramelteon 8mg once daily before bedtime for 12 weeks since informed consent
DRUG	Placebo	Placebo capsule once daily before bedtime for 12 weeks since informed consent

Timeline

• Start date: 2018-02-06
• Primary completion: 2019-07-31
• Completion: 2020-03-16
• First posted: 2018-03-09
• Last updated: 2024-11-20

Locations

1 site across 1 country: Japan