Trial Outcomes & Findings for Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep (NCT NCT03575104)

Last Updated: 2022-03-25

Results Overview

"Wake After Sleep Onset" is the time spent awake after onset of persistent sleep until lights on, as determined by polysomnography.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

924 participants

Primary outcome timeframe

From baseline to Month 1 (i.e. for up to 1 month)

Results posted on

2022-03-25

Participant Flow

Participant milestones

Participant milestones
Measure	Daridorexant 10 mg Daridorexant was administered as tablets, orally, once daily in the evening.	Daridorexant 25 mg Daridorexant was administered as tablets, orally, once daily in the evening.	Placebo Matching placebo was administered as tablets, orally, once daily in the evening.
Overall Study STARTED	307	309	308
Overall Study COMPLETED	283	280	286
Overall Study NOT COMPLETED	24	29	22

Reasons for withdrawal

Reasons for withdrawal
Measure	Daridorexant 10 mg Daridorexant was administered as tablets, orally, once daily in the evening.	Daridorexant 25 mg Daridorexant was administered as tablets, orally, once daily in the evening.	Placebo Matching placebo was administered as tablets, orally, once daily in the evening.
Overall Study Adverse Event	4	3	4
Overall Study Withdrawal by Subject	13	16	11
Overall Study Other reasons	6	8	6
Overall Study Lost to Follow-up	1	2	1

Baseline Characteristics

Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Daridorexant 10 mg n=307 Participants Daridorexant was administered as tablets, orally, once daily in the evening.	Daridorexant 25 mg n=309 Participants Daridorexant was administered as tablets, orally, once daily in the evening.	Placebo n=308 Participants Matching placebo was administered as tablets, orally, once daily in the evening.	Total n=924 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	186 Participants n=93 Participants	188 Participants n=4 Participants	187 Participants n=27 Participants	561 Participants n=483 Participants
Age, Categorical >=65 years	121 Participants n=93 Participants	121 Participants n=4 Participants	121 Participants n=27 Participants	363 Participants n=483 Participants
Age, Continuous	57.1 years STANDARD_DEVIATION 14.0 • n=93 Participants	56.3 years STANDARD_DEVIATION 14.4 • n=4 Participants	56.7 years STANDARD_DEVIATION 14.1 • n=27 Participants	56.7 years STANDARD_DEVIATION 14.2 • n=483 Participants
Sex: Female, Male Female	215 Participants n=93 Participants	218 Participants n=4 Participants	205 Participants n=27 Participants	638 Participants n=483 Participants
Sex: Female, Male Male	92 Participants n=93 Participants	91 Participants n=4 Participants	103 Participants n=27 Participants	286 Participants n=483 Participants
Race/Ethnicity, Customized Hispanic or Latino	17 Participants n=93 Participants	14 Participants n=4 Participants	16 Participants n=27 Participants	47 Participants n=483 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	288 Participants n=93 Participants	295 Participants n=4 Participants	290 Participants n=27 Participants	873 Participants n=483 Participants
Race/Ethnicity, Customized Unknown	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	2 Participants n=483 Participants
Race/Ethnicity, Customized Not permitted as per legislation/regulation	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	2 Participants n=483 Participants
Race/Ethnicity, Customized Black or African American	16 Participants n=93 Participants	26 Participants n=4 Participants	29 Participants n=27 Participants	71 Participants n=483 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	2 Participants n=483 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants	2 Participants n=483 Participants
Race/Ethnicity, Customized Asian	14 Participants n=93 Participants	11 Participants n=4 Participants	10 Participants n=27 Participants	35 Participants n=483 Participants
Race/Ethnicity, Customized White	273 Participants n=93 Participants	271 Participants n=4 Participants	267 Participants n=27 Participants	811 Participants n=483 Participants
Race/Ethnicity, Customized Other	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants

PRIMARY outcome

Timeframe: From baseline to Month 1 (i.e. for up to 1 month)

"Wake After Sleep Onset" is the time spent awake after onset of persistent sleep until lights on, as determined by polysomnography.

Outcome measures

Outcome measures
Measure	Daridorexant 10 mg n=307 Participants Daridorexant was administered as tablets, orally, once daily in the evening.	Daridorexant 25 mg n=309 Participants Daridorexant was administered as tablets, orally, once daily in the evening.	Placebo n=308 Participants Matching placebo was administered as tablets, orally, once daily in the evening.
Change From Baseline to Month 1 in Wake After Sleep Onset (WASO) (Sleep Maintenance)	-15.31 minutes Interval -19.531 to -11.087	-24.19 minutes Interval -28.466 to -19.911	-12.57 minutes Interval -16.817 to -8.323

PRIMARY outcome

Timeframe: From baseline to Month 3 (i.e. for up to 3 months)

"Wake After Sleep Onset" is the time spent awake after onset of persistent sleep until lights on, as determined by polysomnography.

Outcome measures

Outcome measures
Measure	Daridorexant 10 mg n=307 Participants Daridorexant was administered as tablets, orally, once daily in the evening.	Daridorexant 25 mg n=309 Participants Daridorexant was administered as tablets, orally, once daily in the evening.	Placebo n=308 Participants Matching placebo was administered as tablets, orally, once daily in the evening.
Change From Baseline to Month 3 in Wake After Sleep Onset (WASO)	-15.95 minutes Interval -20.734 to -11.165	-24.25 minutes Interval -29.021 to -19.474	-14.00 minutes Interval -18.756 to -9.241

PRIMARY outcome

Timeframe: From baseline to Month 1 (i.e. for up to 1 month)

"Latency to Persistent Sleep" is the time from start of recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-awake, i.e., epochs scored as either sleep stage 1 (S1), sleep stage 2 (S2), sleep stage 3 (slow wave sleep) or REM, as determined by polysomnography.

Outcome measures

Outcome measures
Measure	Daridorexant 10 mg n=307 Participants Daridorexant was administered as tablets, orally, once daily in the evening.	Daridorexant 25 mg n=309 Participants Daridorexant was administered as tablets, orally, once daily in the evening.	Placebo n=308 Participants Matching placebo was administered as tablets, orally, once daily in the evening.
Change From Baseline to Month 1 in Latency to Persistent Sleep (LPS) (Sleep Onset)	-22.62 minutes Interval -26.733 to -18.503	-26.46 minutes Interval -30.626 to -22.292	-20.01 minutes Interval -24.148 to -15.875

PRIMARY outcome

Timeframe: From baseline to Month 3 (i.e. for up to 3 months)

Outcome measures

Outcome measures
Measure	Daridorexant 10 mg n=307 Participants Daridorexant was administered as tablets, orally, once daily in the evening.	Daridorexant 25 mg n=309 Participants Daridorexant was administered as tablets, orally, once daily in the evening.	Placebo n=308 Participants Matching placebo was administered as tablets, orally, once daily in the evening.
Change From Baseline to Month 3 in Latency to Persistent Sleep (LPS)	-23.09 minutes Interval -27.6 to -18.571	-28.91 minutes Interval -33.413 to -24.399	-19.89 minutes Interval -24.384 to -15.405

SECONDARY outcome

Timeframe: From baseline to Month 1 (i.e. for up to 1 month)

"Subjective Total Sleep Time" is the total sleep time reported by the participant in the sleep diary questionnaire. A positive change from baseline indicates an increase in the subjective Total Sleep Time. A negative change from baseline indicates a decrease in subjective Total Sleep Time.

Outcome measures

Outcome measures
Measure	Daridorexant 10 mg n=307 Participants Daridorexant was administered as tablets, orally, once daily in the evening.	Daridorexant 25 mg n=309 Participants Daridorexant was administered as tablets, orally, once daily in the evening.	Placebo n=308 Participants Matching placebo was administered as tablets, orally, once daily in the evening.
Change From Baseline to Month 1 in the Subjective Total Sleep Time (sTST)	41.01 minutes Interval 35.439 to 46.584	43.77 minutes Interval 38.136 to 49.412	27.64 minutes Interval 22.015 to 33.274

SECONDARY outcome

Timeframe: From baseline to Month 3 (i.e. for up to 3 months)

Subjective Total Sleep Time is the total sleep time reported by the participant in the sleep diary questionnaire. A positive change from baseline indicates an increase in the subjective Total Sleep Time. A negative change from baseline indicates a decrease in subjective Total Sleep Time.

Outcome measures

Outcome measures
Measure	Daridorexant 10 mg n=307 Participants Daridorexant was administered as tablets, orally, once daily in the evening.	Daridorexant 25 mg n=309 Participants Daridorexant was administered as tablets, orally, once daily in the evening.	Placebo n=308 Participants Matching placebo was administered as tablets, orally, once daily in the evening.
Change From Baseline to Month 3 in the Subjective Total Sleep Time (sTST)	50.70 minutes Interval 44.398 to 57.008	56.18 minutes Interval 49.812 to 62.547	37.12 minutes Interval 30.776 to 43.464

SECONDARY outcome

Timeframe: From baseline to Month 1 (i.e. for up to 1 month)

The Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) is a validated patient reported outcome instrument comprising 14 items (each using a numeric rating scale from 0 to 10) grouped into three domains (i.e., sleepiness, mood, and alert/cognition) reflecting daytime impairment of insomnia. The IDSIQ sleepiness domain has 4 items, and the domain score ranges from 0 to a maximum of 40, where a higher score indicates a greater burden. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.

Outcome measures

Outcome measures
Measure	Daridorexant 10 mg n=307 Participants Daridorexant was administered as tablets, orally, once daily in the evening.	Daridorexant 25 mg n=309 Participants Daridorexant was administered as tablets, orally, once daily in the evening.	Placebo n=308 Participants Matching placebo was administered as tablets, orally, once daily in the evening.
Change From Baseline to Month 1 in Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) Sleepiness Domain Score	-3.18 Scores on a scale Interval -3.763 to -2.599	-3.51 Scores on a scale Interval -4.096 to -2.917	-2.75 Scores on a scale Interval -3.34 to -2.163

SECONDARY outcome

Timeframe: From baseline to Month 3 (i.e. for up to 3 months)

Outcome measures

Outcome measures
Measure	Daridorexant 10 mg n=307 Participants Daridorexant was administered as tablets, orally, once daily in the evening.	Daridorexant 25 mg n=309 Participants Daridorexant was administered as tablets, orally, once daily in the evening.	Placebo n=308 Participants Matching placebo was administered as tablets, orally, once daily in the evening.
Change From Baseline to Month 3 in IDSIQ Sleepiness Domain Score	-4.75 Scores on a scale Interval -5.437 to -4.056	-5.27 Scores on a scale Interval -5.964 to -4.569	-4.01 Scores on a scale Interval -4.705 to -3.322

POST_HOC outcome

Timeframe: From baseline to Month 1 (i.e. for up to 1 month)

Post-hoc analyses were performed using log-transformed LPS data, as the LPS values at baseline more closely resembled a log-normal distribution (skewed to the right) than a normal distribution.

Outcome measures

Outcome measures
Measure	Daridorexant 10 mg n=307 Participants Daridorexant was administered as tablets, orally, once daily in the evening.	Daridorexant 25 mg n=309 Participants Daridorexant was administered as tablets, orally, once daily in the evening.	Placebo n=308 Participants Matching placebo was administered as tablets, orally, once daily in the evening.
Change From Baseline to Month 1 in Log-transformed LPS (LSGM Ratio to Baseline)	0.59 minutes Interval 0.54 to 0.64	0.50 minutes Interval 0.46 to 0.55	0.63 minutes Interval 0.58 to 0.69

POST_HOC outcome

Timeframe: From baseline to Month 3 (i.e. for up to 3 month)

Post-hoc analyses were performed using log-transformed LPS data, as the LPS values at baseline more closely resembled a log-normal distribution (skewed to the right) than a normal distribution.

Outcome measures

Outcome measures
Measure	Daridorexant 10 mg n=307 Participants Daridorexant was administered as tablets, orally, once daily in the evening.	Daridorexant 25 mg n=309 Participants Daridorexant was administered as tablets, orally, once daily in the evening.	Placebo n=308 Participants Matching placebo was administered as tablets, orally, once daily in the evening.
Change From Baseline to Month 3 in Log-transformed LPS (LSGM Ratio to Baseline)	0.56 minutes Interval 0.51 to 0.61	0.48 minutes Interval 0.43 to 0.52	0.58 minutes Interval 0.53 to 0.64

Adverse Events

Daridorexant 10 mg

Serious events: 3 serious events

Other events: 49 other events

Deaths: 0 deaths

Daridorexant 25 mg

Serious events: 3 serious events

Other events: 28 other events

Deaths: 0 deaths

Placebo

Serious events: 4 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Daridorexant 10 mg n=306 participants at risk Daridorexant was administered as tablets, orally, once daily in the evening.	Daridorexant 25 mg n=308 participants at risk Daridorexant was administered as tablets, orally, once daily in the evening.	Placebo n=306 participants at risk Matching placebo was administered as tablets, orally, once daily in the evening.
Vascular disorders Hypertensive crisis	0.00% 0/306 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days. The number of subjects affected is the number of subjects with at least one event.	0.00% 0/308 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days. The number of subjects affected is the number of subjects with at least one event.	0.33% 1/306 • Number of events 1 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days. The number of subjects affected is the number of subjects with at least one event.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/306 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days. The number of subjects affected is the number of subjects with at least one event.	0.00% 0/308 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days. The number of subjects affected is the number of subjects with at least one event.	0.33% 1/306 • Number of events 1 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days. The number of subjects affected is the number of subjects with at least one event.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/306 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days. The number of subjects affected is the number of subjects with at least one event.	0.00% 0/308 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days. The number of subjects affected is the number of subjects with at least one event.	0.33% 1/306 • Number of events 1 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days. The number of subjects affected is the number of subjects with at least one event.
Cardiac disorders Microvascular coronary artery disease	0.33% 1/306 • Number of events 1 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days. The number of subjects affected is the number of subjects with at least one event.	0.00% 0/308 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days. The number of subjects affected is the number of subjects with at least one event.	0.00% 0/306 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days. The number of subjects affected is the number of subjects with at least one event.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/306 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days. The number of subjects affected is the number of subjects with at least one event.	0.32% 1/308 • Number of events 1 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days. The number of subjects affected is the number of subjects with at least one event.	0.00% 0/306 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days. The number of subjects affected is the number of subjects with at least one event.
Nervous system disorders Lumbar radiculopathy	0.00% 0/306 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days. The number of subjects affected is the number of subjects with at least one event.	0.32% 1/308 • Number of events 1 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days. The number of subjects affected is the number of subjects with at least one event.	0.00% 0/306 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days. The number of subjects affected is the number of subjects with at least one event.
Ear and labyrinth disorders Vertigo	0.33% 1/306 • Number of events 1 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days. The number of subjects affected is the number of subjects with at least one event.	0.00% 0/308 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days. The number of subjects affected is the number of subjects with at least one event.	0.00% 0/306 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days. The number of subjects affected is the number of subjects with at least one event.
Psychiatric disorders Schizophrenia	0.00% 0/306 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days. The number of subjects affected is the number of subjects with at least one event.	0.32% 1/308 • Number of events 1 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days. The number of subjects affected is the number of subjects with at least one event.	0.00% 0/306 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days. The number of subjects affected is the number of subjects with at least one event.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/306 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days. The number of subjects affected is the number of subjects with at least one event.	0.00% 0/308 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days. The number of subjects affected is the number of subjects with at least one event.	0.33% 1/306 • Number of events 1 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days. The number of subjects affected is the number of subjects with at least one event.
Infections and infestations Appendicitis	0.33% 1/306 • Number of events 1 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days. The number of subjects affected is the number of subjects with at least one event.	0.00% 0/308 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days. The number of subjects affected is the number of subjects with at least one event.	0.00% 0/306 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days. The number of subjects affected is the number of subjects with at least one event.

Other adverse events

Other adverse events
Measure	Daridorexant 10 mg n=306 participants at risk Daridorexant was administered as tablets, orally, once daily in the evening.	Daridorexant 25 mg n=308 participants at risk Daridorexant was administered as tablets, orally, once daily in the evening.	Placebo n=306 participants at risk Matching placebo was administered as tablets, orally, once daily in the evening.
Nervous system disorders Headache	4.6% 14/306 • Number of events 19 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days. The number of subjects affected is the number of subjects with at least one event.	5.2% 16/308 • Number of events 16 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days. The number of subjects affected is the number of subjects with at least one event.	3.6% 11/306 • Number of events 12 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days. The number of subjects affected is the number of subjects with at least one event.
Infections and infestations Nasopharyngitis	12.4% 38/306 • Number of events 41 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days. The number of subjects affected is the number of subjects with at least one event.	4.2% 13/308 • Number of events 15 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days. The number of subjects affected is the number of subjects with at least one event.	6.5% 20/306 • Number of events 22 • Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days. The number of subjects affected is the number of subjects with at least one event.

Additional Information

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