Trial · NCT02783729
Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1)
NCT02783729, Phase 3, Completed, Eisai Inc.; results first posted 2020-02-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1). Trials, record NCT02783729. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02783729
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1)
- NCT number
- NCT02783729
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,006 participants, actual
- Lead sponsor
- Eisai Inc.
- Conditions
- Insomnia
- Interventions
- Lemborexant, Lemborexant, Lemborexant-matched placebo, Zolpidem tartrate, Zolpidem-matched placebo
- First posted
- 2016-05-26
- Last updated
- 2024-11-12
- Other registries' IDs
- eudract:2015-004347-39
- Results first posted
- 2020-02-11
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Mean Latency to Persistent Sleep (LPS) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 29/30 | Baseline, Days 29/30 | LPS is defined as the time in minutes from lights off to the first epoch of 20 consecutive epochs of non- wakefulness as measured by PSG. Change from baseline to average LPS on Day 29 and 30 was reported. |
| Secondary | Change From Baseline in Mean Sleep Efficiency (SE) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 29/30 | Baseline, Days 29/30 | SE is defined as percentage of time spent in bed asleep, calculated as total sleep time (TST) divided by interval from lights off until lights on as measured by PSG, multiplied by 100. Change from baseline to average SE on Day 29 and 30 was reported. |
| Secondary | Change From Baseline in Mean Wake After Sleep Onset (WASO) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 29/30 | Baseline, Days 29/30 | WASO is defined as minutes of wake from the onset of persistent sleep until lights on as measured by PSG. Change from baseline to average WASO on Days 29 and 30 was reported. |
| Secondary | Change From Baseline in WASO in the Second Half of the Night (WASO2H) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Zolpidem ER on Days 29/30 | Baseline, Days 29/30 | WASO2H is defined as time in minutes of wake during the interval from 240 minutes after lights off until lights on as measured by PSG. Change from baseline to average WASO2H on Days 29 and 30 was reported. |
| Other | Change From Baseline in Mean Body Sway Upon Awakening in the Morning for Lemborexant 5 mg and Lemborexant 10 mg Compared to Zolpidem ER on Days 2/3 | Baseline, Days 2/3 | Body sway is detected through a cable around the participant's waist by the ataxia meter. Body sway is measured in units of one-third degree of the angle of arc. For ease in reporting, these are called arbitrary units, with a higher number indicating more body sway (less postural stability). Change from baseline in mean body sway on Days 2 and 3 was reported. |
| Other | Change From Baseline in Mean LPS, WASO, and TST of Lemborexant 10 mg and Lemborexant 5 mg Compared to Zolpidem ER on Days 1/2 and Days 29/30 | Baseline, Days 1/2, and Days 29/30 | LPS is defined as the time in minutes from lights off to the first epoch of 20 consecutive epochs of non-wakefulness as measured by the PSG. WASO is defined as minutes of wake from the onset of persistent sleep until lights on as measured by PSG. TST is defined as the amount of sleep in minutes from LPS until terminal awakening as measured by PSG. Change from baseline to average LPS, WASO, and TST on Days 1 and 2, and Days 29 and 30 were reported. |
| Other | Change From Baseline in Subjective Sleep Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO) and Subjective Total Sleep Time (sTST) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Zolpidem ER | First 7 nights (approximately Week 1) and Last 7 nights (approximately Week 4) | sSOL: estimated minutes from time attempted to sleep to sleep onset. sWASO: estimated minutes of wake at night after initial sleep onset to time stopped trying to sleep for the night. sTST: minutes of sleep from sleep onset to time stopped trying to sleep for the night. sSOL, sWASO, sTST were analyzed with diary handling rules (DHR) on an electronic sleep diary. Subjective measures were derived from sleep diaries entries, collected daily and analyzed at appropriate intervals. |
| Other | Change From Baseline in Subjective Sleep Efficiency (sSE) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Zolpidem ER | First 7 nights (approximately Week 1) and Last 7 nights (approximately Week 4) | sSE: percentage of sTST per subjective time spent in bed asleep, calculated as the interval from the time attempted to sleep to time stopped trying to sleep for the night, and time spent asleep derived from subjective time spent in bed minus sWASO. sWASO: estimated minutes of wake at night after initial sleep onset to time stopped trying to sleep for the night. sSE was analyzed with DHR on an electronic sleep diary. Subjective measures were derived from sleep diaries entries, collected daily and analyzed at appropriate intervals. |
| Other | Change From Baseline in Mean LPS, WASO, WASO2H, and TST of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 1/2 | Baseline, Days 1/2 | LPS: amount of time in minutes from lights off to first epoch of 20 consecutive epochs of non-wakefulness. WASO: amount of time in minutes of wake from the onset of persistent sleep until lights. WASO2H: amount of time in minutes of wake during the interval from 240 minutes after lights off until lights on. TST: amount of time in minutes of sleep from sleep onset until terminal awakening. LPS, WASO, WASO2H, and TST were measured by PSG. Change from baseline to average LPS, WASO, WASO2H, and TST on Day 1 and 2 were reported. |
| Other | Change From Baseline in Mean SE of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 1/2 | Baseline, Days 1/2 | SE is defined as percentage of time spent in bed asleep, calculated as TST divided by interval from lights off until lights on as measured by PSG, multiplied by 100. Change from baseline to average SE on Day 1 and 2 were reported. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
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 Mean Latency to Persistent Sleep (LPS) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 29/30 | Baseline, Days 29/30 | FAS was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement at given time points. | minutes | MEAN |
| SECONDARY | Change From Baseline in Mean Sleep Efficiency (SE) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 29/30 | Baseline, Days 29/30 | The FAS was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement at given time points. | Percentage of time in bed asleep | MEAN |
| SECONDARY | Change From Baseline in Mean Wake After Sleep Onset (WASO) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 29/30 | Baseline, Days 29/30 | FAS was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement at given time points. | minutes | MEAN |
| SECONDARY | Change From Baseline in WASO in the Second Half of the Night (WASO2H) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Zolpidem ER on Days 29/30 | Baseline, Days 29/30 | FAS was the group of randomized Participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement at given time points. | minutes | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in Mean Body Sway Upon Awakening in the Morning for Lemborexant 5 mg and Lemborexant 10 mg Compared to Zolpidem ER on Days 2/3 | Baseline, Days 2/3 | The FAS was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement at given time points. | one-third degree of angle of arc | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in Mean LPS, WASO, and TST of Lemborexant 10 mg and Lemborexant 5 mg Compared to Zolpidem ER on Days 1/2 and Days 29/30 | Baseline, Days 1/2, and Days 29/30 | FAS was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement at given time points. | minutes | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in Subjective Sleep Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO) and Subjective Total Sleep Time (sTST) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Zolpidem ER | First 7 nights (approximately Week 1) and Last 7 nights (approximately Week 4) | FAS was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement at given time points. | minutes | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in Subjective Sleep Efficiency (sSE) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Zolpidem ER | First 7 nights (approximately Week 1) and Last 7 nights (approximately Week 4) | FAS was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement at given time points. | % of subjective time in bed asleep | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in Mean LPS, WASO, WASO2H, and TST of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 1/2 | Baseline, Days 1/2 | FAS was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement. | minutes | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in Mean SE of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 1/2 | Baseline, Days 1/2 | FAS was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement. | Percentage of time in bed asleep | MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group251
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 Mean Latency to Persistent Sleep (LPS) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 29/30 | Placebo | Baseline | 43.89 | Standard Deviation 33.596 | minutes |
| Change From Baseline in Mean Latency to Persistent Sleep (LPS) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 29/30 | Lemborexant 5 mg | Baseline | 44.86 | Standard Deviation 36.528 | minutes |
| Change From Baseline in Mean Latency to Persistent Sleep (LPS) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 29/30 | Lemborexant 10 mg | Baseline | 44.61 | Standard Deviation 32.986 | minutes |
| Change From Baseline in Mean Latency to Persistent Sleep (LPS) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 29/30 | Placebo | Change at Days 29/30 | -7.93 | Standard Deviation 31.946 | minutes |
| Change From Baseline in Mean Latency to Persistent Sleep (LPS) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 29/30 | Lemborexant 5 mg | Change at Days 29/30 | -19.53 | Standard Deviation 33.054 | minutes |
| Change From Baseline in Mean Latency to Persistent Sleep (LPS) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 29/30 | Lemborexant 10 mg | Change at Days 29/30 | -21.46 | Standard Deviation 32.436 | minutes |
| Change From Baseline in Mean Sleep Efficiency (SE) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 29/30 | Placebo | Baseline | 68.89 | Standard Deviation 9.639 | Percentage of time in bed asleep |
| Change From Baseline in Mean Sleep Efficiency (SE) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 29/30 | Lemborexant 5 mg | Baseline | 68.36 | Standard Deviation 11.268 | Percentage of time in bed asleep |
| Change From Baseline in Mean Sleep Efficiency (SE) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 29/30 | Lemborexant 10 mg | Baseline | 67.85 | Standard Deviation 10.849 | Percentage of time in bed asleep |
| Change From Baseline in Mean Sleep Efficiency (SE) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 29/30 | Placebo | Change at Days 29/30 | 5.35 | Standard Deviation 9.897 | Percentage of time in bed asleep |
1 to 10 of 251Source ClinicalTrials.gov
See all 251 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 208 | |
| Overall Study | STARTED | Zolpidem Tartrate Extended Release 6.25 mg | 263 | |
| Overall Study | STARTED | Lemborexant 5 mg | 266 | |
| Overall Study | STARTED | Lemborexant 10 mg | 269 | |
| Overall Study | COMPLETED | Placebo | 198 | |
| Overall Study | COMPLETED | Zolpidem Tartrate Extended Release 6.25 mg | 246 | |
| Overall Study | COMPLETED | Lemborexant 5 mg | 258 | |
| Overall Study | COMPLETED | Lemborexant 10 mg | 260 | |
| Overall Study | NOT COMPLETED | Placebo | 10 | |
| Overall Study | NOT COMPLETED | Zolpidem Tartrate Extended Release 6.25 mg | 17 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events50
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 | Headache | Nervous system disorders | Placebo | 13 | 209 | 13 |
| other | Headache | Nervous system disorders | Zolpidem Tartrate Extended Release 6.25 mg | 14 | 263 | 21 |
| other | Headache | Nervous system disorders | Lemborexant 5 mg | 17 | 266 | 21 |
| other | Headache | Nervous system disorders | Lemborexant 10 mg | 13 | 268 | 15 |
| other | Headache | Nervous system disorders | Run -in Period Placebo | 34 | 1,006 | 34 |
| other | Somnolence | Nervous system disorders | Placebo | 4 | 209 | 4 |
| other | Somnolence | Nervous system disorders | Zolpidem Tartrate Extended Release 6.25 mg | 4 | 263 | 5 |
| other | Somnolence | Nervous system disorders | Lemborexant 5 mg | 11 | 266 | 11 |
| other | Somnolence | Nervous system disorders | Lemborexant 10 mg | 19 | 268 | 20 |
| other | Somnolence | Nervous system disorders | Run -in Period Placebo | 0 | 1,006 | 0 |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 209 |
| Total, all-cause mortality | Zolpidem Tartrate Extended Release 6.25 mg | 0 | 263 |
| Total, all-cause mortality | Lemborexant 5 mg | 0 | 266 |
| Total, all-cause mortality | Lemborexant 10 mg | 0 | 268 |
| Total, all-cause mortality | Run -in Period Placebo | 0 | 1,006 |
| Total, other adverse events | Placebo | 16 | 209 |
| Total, other adverse events | Zolpidem Tartrate Extended Release 6.25 mg | 18 | 263 |
| Total, other adverse events | Lemborexant 5 mg | 27 | 266 |
| Total, other adverse events | Lemborexant 10 mg | 28 | 268 |
| Total, other adverse events | Run -in Period Placebo | 34 | 1,006 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers9
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.
Tests3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Choice Reaction Time | Other outcome | ConductCognition |
| Delayed Recall Module | Other outcome | ConductCognition |
| Simple Reaction Time | Other outcome | ConductCognition |
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/NCT02783729
GET https://conductscience.org/api/trials/v1/NCT02783729/results?page=2