Trial · NCT02952820
Long-term Study of Lemborexant in Insomnia Disorder (SUNRISE 2)
NCT02952820, Phase 3, Completed, Eisai Inc.; results first posted 2020-01-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Long-term Study of Lemborexant in Insomnia Disorder (SUNRISE 2). Trials, record NCT02952820. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02952820
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-term Study of Lemborexant in Insomnia Disorder (SUNRISE 2)
- NCT number
- NCT02952820
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 971 participants, actual
- Lead sponsor
- Eisai Inc.
- Conditions
- Insomnia Disorder
- Interventions
- lemborexant, Placebo
- First posted
- 2016-11-02
- Last updated
- 2020-02-06
- Other registries' IDs
- eudract:2015-001463-39
- Results first posted
- 2020-01-21
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Subjective Sleep Onset Latency (sSOL) at Month 6 | Baseline and Month 6 | sSOL was defined as estimated minutes from the time that the participant attempted to sleep until sleep onset. |
| Secondary | Change From Baseline in sSOL at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Placebo-Controlled Period), and at Months 1 and 3 | Baseline, (mean of 7 nights [approximately Week 1]), Months 1 and 3 | sSOL was defined as estimated minutes from time attempted to sleep to sleep onset. |
| Secondary | Change From Baseline in Subjective Sleep Efficiency (sSE) at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Placebo-Controlled Period), and at Months 1, 3 and 6 | Baseline, (mean of 7 nights [approximately Week 1]), Months 1, 3 and 6 | sSE was defined as percentage of subjective total sleep time (sTST) divided by subjective time spent in bed, calculated as the interval from the time the participant reported attempting to sleep until the time participant stopped trying to sleep for the night (operationalized as the time the participant got out of bed for the day), and time spent asleep derived from subjective time spent in bed minus sWASO. |
| Secondary | Change From Baseline in Subjective Wake After Sleep Onset (sWASO) at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Placebo-Controlled Period), and at Months 1, 3 and 6 | Baseline, (mean of 7 nights [approximately Week 1]), Months 1, 3 and 6 | sWASO was defined as sum of estimated minutes of wake during the night after initial sleep onset until the time the participant stopped trying to sleep for the night, operationalized as the time the participant got out of bed for the day. |
| Secondary | Change From Baseline in sTST at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Placebo-Controlled Period), and at Months 1, 3 and 6 | Baseline, (mean of 7 nights [approximately Week 1]), Months 1, 3 and 6 | sTST was defined as minutes of sleep from sleep onset to time stopped trying to sleep for the night. |
| Secondary | Percentage of Sleep Onset Responders and Sleep Maintenance Responders at Month 6 | Month 6 | Sleep onset responder was defined as follows: sSOL at study Baseline was greater than or equal to (\>=) 30 minutes and mean sSOL at 6 months was less than or equal to (\<=) 20 minutes. Sleep maintenance responder was defined as follows: sWASO at study Baseline was \>=60 minutes and mean sWASO at 6 months was \<=60 minutes and showed a reduction of greater than (\>)10 minutes compared to Study Baseline. |
| Secondary | Percentage of Sleep Onset Responders and Sleep Maintenance Responders at Month 12 | Month 12 | Sleep onset responder was defined as follows: sSOL at study Baseline was \>=30 minutes and mean sSOL at 6 months was \<=20 minutes. Sleep maintenance responder was defined as follows: sWASO at study Baseline was \>=60 minutes and mean sWASO at 6 months was \<=60 minutes and showed a reduction of \> 10 minutes compared to study Baseline. |
| Secondary | Change From Baseline in Insomnia Severity Index (ISI) Daytime Functioning Score at Months 1, 3, and 6 | Baseline, Months 1, 3, and 6 | The ISI is a 4-7 item, self-report questionnaire assessing the nature, severity, and impact of insomnia. The dimensions evaluated were: 1. severity of sleep onset; 2. sleep maintenance; 3. early morning awakening problems; 4. sleep dissatisfaction; 5. interference of sleep difficulties with daytime functioning; 6. noticeability of the sleep problems by others; and 7. distress caused by the sleep difficulties. A 5-point Likert scale was used to rate each item (from 0=no problem to 4=very severe problem). Daytime functioning score (sum of items 4 to 7) were analyzed. Higher score indicated severe insomnia problem. The total score range for sum of items is 0-16. |
| Secondary | Change From Baseline in Fatigue Severity Scale (FSS) Total Score at Months 1, 3 and 6 | Baseline, Months 1, 3 and 6 | The FSS is a self-reported scale on which participants were instructed to choose a number from 1 to 7 that indicated their degree of agreement with 9 statements about their fatigue where "1" indicates strongly disagree and "7", strongly agree. The FSS total score was the sum of all responses to the 9 questions. Higher total scores and average item scores indicated greater fatigue. Total score range is 9 to 63. |
| Secondary | Change From Baseline in Mean Rating on the Morning Sleepiness Item of the Sleep Diary at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Placebo-Controlled Period), and at Months 1, 3 and 6 | Baseline, (mean of 7 nights [approximately Week 1]) in placebo-controlled period, Month 1, 3, 6 | The Sleep Diary was used to assess subjective ratings of morning sleepiness with the following question: "How sleepy/alert do you feel this morning?" Participants rated their sleepiness/alertness level on a scale from 1 to 9, with 1 being extremely poor (sleepy) and 9 being extremely good (alert). Higher score indicated better outcome. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Subjective Sleep Onset Latency (sSOL) at Month 6 | Baseline and Month 6 | The FAS was the group of randomized participants who received at least one dose of randomized study drug and had at least one postdose primary efficacy measurement. Number analyzed refers to participants evaluable for this outcome measure at specified time point. | minutes | MEAN |
| SECONDARY | Change From Baseline in sSOL at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Placebo-Controlled Period), and at Months 1 and 3 | Baseline, (mean of 7 nights [approximately Week 1]), Months 1 and 3 | The FAS was the group of randomized participants who received at least one dose of randomized study drug and had at least one postdose primary efficacy measurement. Number analyzed refers to participants evaluable for this outcome measure at specified time point. | minutes | MEAN |
| SECONDARY | Change From Baseline in Subjective Sleep Efficiency (sSE) at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Placebo-Controlled Period), and at Months 1, 3 and 6 | Baseline, (mean of 7 nights [approximately Week 1]), Months 1, 3 and 6 | The FAS was the group of randomized participants who received at least one dose of randomized study drug and had at least one postdose primary efficacy measurement. Number analyzed refers to participants evaluable for this outcome measure at specified time point. | percentage of sTST | MEAN |
| SECONDARY | Change From Baseline in Subjective Wake After Sleep Onset (sWASO) at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Placebo-Controlled Period), and at Months 1, 3 and 6 | Baseline, (mean of 7 nights [approximately Week 1]), Months 1, 3 and 6 | The FAS was the group of randomized participants who received at least one dose of randomized study drug and had at least one postdose primary efficacy measurement. Number analyzed refers to participants evaluable for this outcome measure at specified time point. | minutes | MEAN |
| SECONDARY | Change From Baseline in sTST at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Placebo-Controlled Period), and at Months 1, 3 and 6 | Baseline, (mean of 7 nights [approximately Week 1]), Months 1, 3 and 6 | The FAS was the group of randomized participants who received at least one dose of randomized study drug and had at least one postdose primary efficacy measurement. Number analyzed refers to participants evaluable for this outcome measure at specified time point. | minutes | MEAN |
| SECONDARY | Percentage of Sleep Onset Responders and Sleep Maintenance Responders at Month 6 | Month 6 | The FAS was the group of randomized participants who received at least one dose of randomized study drug and had at least one postdose primary efficacy measurement. Number analyzed refers to number of participants evaluable for specified category. | percentage of responders | NUMBER |
| SECONDARY | Percentage of Sleep Onset Responders and Sleep Maintenance Responders at Month 12 | Month 12 | Overall participants analyzed based on number in On-Treatment FAS (Participants who received at least 1 dose of lemborexant and had at least 1 postdose primary efficacy measurement). Hence, these numbers include lemborexant data from participants re-randomized from placebo in Period 1. Number analyzed=participants analyzed at specified timepoint. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Insomnia Severity Index (ISI) Daytime Functioning Score at Months 1, 3, and 6 | Baseline, Months 1, 3, and 6 | The FAS was the group of randomized participants who received at least one dose of randomized study drug and had at least one postdose primary efficacy measurement. Number analyzed refers to participants evaluable for this outcome measure at specified time point. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Fatigue Severity Scale (FSS) Total Score at Months 1, 3 and 6 | Baseline, Months 1, 3 and 6 | The FAS was the group of randomized participants who received at least one dose of randomized study drug and had at least one postdose primary efficacy measurement. Number analyzed refers to participants evaluable for this outcome measure at specified time point. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Mean Rating on the Morning Sleepiness Item of the Sleep Diary at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Placebo-Controlled Period), and at Months 1, 3 and 6 | Baseline, (mean of 7 nights [approximately Week 1]) in placebo-controlled period, Month 1, 3, 6 | The FAS was the group of randomized participants who received at least one dose of randomized study drug and had at least one postdose primary efficacy measurement. Number analyzed refers to participants evaluable for this outcome measure at specified time point. | score on a scale | MEAN |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group246
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Subjective Sleep Onset Latency (sSOL) at Month 6 | Placebo | Baseline | 64.03 | Standard Deviation 45.209 | minutes |
| Change From Baseline in Subjective Sleep Onset Latency (sSOL) at Month 6 | Lemborexant 5 mg | Baseline | 62.19 | Standard Deviation 45.674 | minutes |
| Change From Baseline in Subjective Sleep Onset Latency (sSOL) at Month 6 | Lemborexant 10 mg | Baseline | 64.97 | Standard Deviation 44.020 | minutes |
| Change From Baseline in Subjective Sleep Onset Latency (sSOL) at Month 6 | Placebo | Change at Month 6 | -16.57 | Standard Deviation 35.313 | minutes |
| Change From Baseline in Subjective Sleep Onset Latency (sSOL) at Month 6 | Lemborexant 5 mg | Change at Month 6 | -29.39 | Standard Deviation 33.261 | minutes |
| Change From Baseline in Subjective Sleep Onset Latency (sSOL) at Month 6 | Lemborexant 10 mg | Change at Month 6 | -32.49 | Standard Deviation 35.962 | minutes |
| Change From Baseline in sSOL at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Placebo-Controlled Period), and at Months 1 and 3 | Placebo | Baseline | 64.03 | Standard Deviation 45.209 | minutes |
| Change From Baseline in sSOL at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Placebo-Controlled Period), and at Months 1 and 3 | Lemborexant 5 mg | Baseline | 62.19 | Standard Deviation 45.674 | minutes |
| Change From Baseline in sSOL at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Placebo-Controlled Period), and at Months 1 and 3 | Lemborexant 10 mg | Baseline | 64.97 | Standard Deviation 44.020 | minutes |
| Change From Baseline in sSOL at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Placebo-Controlled Period), and at Months 1 and 3 | Placebo | Change at 1st 7 nights | -4.11 | Standard Deviation 27.671 | minutes |
1 to 10 of 246Source ClinicalTrials.gov
See all 246 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Placebo-Controlled Treatment (6 Months) | STARTED | Placebo | 325 | |
| Placebo-Controlled Treatment (6 Months) | STARTED | Lemborexant 5 mg | 323 | |
| Placebo-Controlled Treatment (6 Months) | STARTED | Lemborexant 10 mg | 323 | |
| Placebo-Controlled Treatment (6 Months) | Treated | Placebo | 321 | |
| Placebo-Controlled Treatment (6 Months) | Treated | Lemborexant 5 mg | 319 | |
| Placebo-Controlled Treatment (6 Months) | Treated | Lemborexant 10 mg | 319 | |
| Placebo-Controlled Treatment (6 Months) | Safety Analysis Set | Placebo | 319 | |
| Placebo-Controlled Treatment (6 Months) | Safety Analysis Set | Lemborexant 5 mg | 314 | |
| Placebo-Controlled Treatment (6 Months) | Safety Analysis Set | Lemborexant 10 mg | 314 | |
| Placebo-Controlled Treatment (6 Months) | COMPLETED | Placebo | 261 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events150
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Influenza | Infections and infestations | Placebo | 15 | 319 | 15 |
| other | Influenza | Infections and infestations | Lemborexant 5 mg | 22 | 447 | 22 |
| other | Influenza | Infections and infestations | Lemborexant 10 mg | 26 | 437 | 29 |
| other | Nasopharyngitis | Infections and infestations | Placebo | 40 | 319 | 43 |
| other | Nasopharyngitis | Infections and infestations | Lemborexant 5 mg | 51 | 447 | 67 |
| other | Nasopharyngitis | Infections and infestations | Lemborexant 10 mg | 48 | 437 | 56 |
| other | Headache | Nervous system disorders | Placebo | 21 | 319 | 33 |
| other | Headache | Nervous system disorders | Lemborexant 5 mg | 43 | 447 | 76 |
| other | Headache | Nervous system disorders | Lemborexant 10 mg | 32 | 437 | 41 |
| other | Somnolence | Nervous system disorders | Placebo | 5 | 319 | 5 |
1 to 10 of 150Source ClinicalTrials.gov
See all 150 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 319 |
| Total, all-cause mortality | Lemborexant 5 mg | 0 | 447 |
| Total, all-cause mortality | Lemborexant 10 mg | 0 | 437 |
| Total, other adverse events | Placebo | 75 | 319 |
| Total, other adverse events | Lemborexant 5 mg | 129 | 447 |
| Total, other adverse events | Lemborexant 10 mg | 140 | 437 |
| Total, serious adverse events | Placebo | 5 | 319 |
| Total, serious adverse events | Lemborexant 5 mg | 18 | 447 |
| Total, serious adverse events | Lemborexant 10 mg | 16 | 437 |
Source ClinicalTrials.gov
Papers12
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02952820
GET https://conductscience.org/api/trials/v1/NCT02952820/registered?page=2