N/A
Completed N=236
Ramelteon 8 mg Tablets Specified Drug-use Survey: <Long-term Survey on Insomnia Accompanied by Difficulty Falling Asleep> - Transitional Survey From the Preceding Drug-use Survey -
Source: ClinicalTrials.gov NCT02153086 ↗Enrolled (actual)
236
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcomePrimary: Number of Participants Reporting One or More Adverse Drug Reactions — 0 participants
Summary
The purpose of this survey is to examine the safety and efficacy of long-term use of ramelteon tablets (Rozerem 8 mg Tablets) in participants with difficulty falling asleep associated with insomnia in daily medical practice.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting One or More Adverse Drug Reactions |
— | — |
| SECONDARY Sleep Status: Sleep Onset Latency |
98.7; 48.3; 38.9 | — |
| SECONDARY Sleep Status: Total Sleep Time |
6.74; 7.51; 7.46 | — |
| SECONDARY Sleep Status: Number of Awakenings |
2.3; 1.2; 1.1 | — |
| SECONDARY Percentage of Participants Reported With Improvement on the Patient Global Impression (PGI) Scale for Sleep Onset |
80.2; 93.2; 85.5 | — |
| SECONDARY Percentage of Participants Reported With Improvement on the PGI Scale for Sleep Duration |
77.8; 93.2; 84.0 | — |
| SECONDARY Percentage of Participants Reported With Improvement on the PGI Scale for Sleep Quality |
80.2; 93.2; 86.0 | — |
| SECONDARY Percentage of Participants Reported With Improvement on the PGI Scale for Morning Awakening |
67.6; 87.5; 77.8 | — |
| SECONDARY Percentage of Participants Reported With Improvement on the PGI Scale for Remaining Tiredness in the Morning |
72.5; 81.8; 77.3 | — |
| SECONDARY Percentage of Participants Reported With Improvement on the PGI Scale for Daytime Somnolence |
65.2; 81.8; 76.8 | — |
| SECONDARY Percentage of Participants Reported With Improvement on the PGI Scale for Daytime Physical Condition/Function |
70.5; 84.1; 77.3 | — |
Eligibility Criteria
Inclusion Criteria
-Participants with difficulty falling asleep associated with insomnia who have completed a 4-week follow-up in the preceding drug use surveillance and are able to receive continuous administration of Rozerem Tablets
Exclusion Criteria
- Participants with contraindications to Rozerem Tablets.
- Participants with previous history of hypersensitivity to ingredients in Rozerem Tablets.
- Participants with severe liver dysfunction.
- Participants taking fluvoxamine maleate
Data sourced from ClinicalTrials.gov (NCT02153086). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.