N/A
Completed N=3,339
Ramelteon Tablets 8mg Drug Use Surveillance: Survey on Insomnia Associated With Sleep-onset Difficulty
Source: ClinicalTrials.gov NCT02058992 ↗Enrolled (actual)
3,339
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcomePrimary: Number of Participants Reporting One or More Adverse Drug Reactions — 109 participants
Summary
The purpose of this study is to investigate the safety and efficacy of ramelteon (Rozerem) when used in the routine clinical setting in patients with sleep-onset difficulty associated with insomnia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting One or More Adverse Drug Reactions |
109 | — |
| PRIMARY Number of Participants Reporting One or More Serious Adverse Drug Reactions |
1 | — |
| SECONDARY Sleep Status: Sleep Onset Latency |
89.8; 47.1 | — |
| SECONDARY Sleep Status: Total Sleep Time |
6.49; 7.31 | — |
| SECONDARY Sleep Status: Number of Awakenings |
2.1; 1.2 | — |
| SECONDARY Percentage of Participants Who Responded With Improvement on the Patient Global Impression (PGI) Scale at Week 4 |
69.6; 63.8; 64.8; 54.0; 52.9; 51.9 | — |
Eligibility Criteria
Inclusion Criteria
- Sleep-onset difficulty associated with insomnia
Exclusion Criteria
- Patients with previous history of hypersensitivity to an ingredient of Rozerem Tablets
- Patients with severe liver dysfunction
- Patients taking fluvoxamine maleate
Data sourced from ClinicalTrials.gov (NCT02058992). 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.