Idorsia Ltd. · SIX:IDIA
Idorsia — Sleep Europe 2026
22 slides from Idorsia's conference presentation, Oct 23, 2026
Slide 1: The dual orexin receptor antagonist daridorexant in pediatric insomnia disorder
The dual orexin receptor antagonist daridorexant in pediatric insomnia disorder An Idorsia-sponsored study Carmen Schröder1, 2, 3, Akinyemi Ajayi4, Oliviero Bruni5, Yves Dauvilliers6, 7, Ingo Fietze8, Katharina Lederer8, Judith Owens9, Adela Fraile10, Fabio Pizza11, 12, Martine Clozel13, Chiara De S
Slide 2: Disclosure of Conflicts of Interest: Prof Carmen Schröder
Disclosure of Conflicts of Interest : Prof Carmen Schröder Title •I declare the following potential conflicts of interest: Title - Company affiliations : N/A - Research grants : N/A - Subtitle Consultancies / Speaker honoraria : Idorsia, Neurim, Biocodex, InfektoPharm, Medice, Salmon
Slide 3: Pediatric insomnia: Common, persistent with significant clinical consequences
Pediatric insomnia: Common, persistent with significant clinical consequences Fine and gross motor development Learning & memory Metabolic balance / diabetes Attention Prevalence (~8-12 %) 1,2 increases from childhood to adolescence and may persist over time 3 Overweight / obesity ↓ Alertness Adult
Slide 4: Pediatric insomnia in neurodevelopmental disorders
Pediatric insomnia In neurodevelopmental disorders NDDs affect 1 in 6–8 children worldwide 1 Insomnia symptoms are even more prevalent in NDDs 2–4: • ASD (50-80 %) • ADHD (25-75 %) Insomnia worsens NDD core symptoms and comorbidities 5–7 NDD, neurodevelopmental disorders. 1. Zablotsky B, et al. Pedi
Slide 5: Current treatment options do not fully address the needs of children and families
Current treatment options do not fully address the needs of children and families First-line care 1-3 • Sleep hygiene progressing to behavioral interventions are recommended first-line • CBT-I access remains limited and may be impractical for some patients and families Pharmacological options 4 • EU
Slide 6: Orexin is a central regulator of wakefulness and a rational therapeutic target in insomnia disorder
Orexin is a central regulator of wakefulness and a rational therapeutic target in insomnia disorder 1–6 DORAs reduce orexin signaling 1 DORAs 4 Orexin 5 NDD and pediatric insomnia relevance: • Orexin modulates wakefulness and arousal 1,2 Precipitating Underlying event vulnerability Insomnia Hyperaro
Slide 7: Daridorexant: Optimized PK profile designed to balance nighttime efficacy and daytime functioning
Daridorexant: Optimized PK profile designed to balance nighttime efficacy and daytime functioning Daridorexant plasma concentrations3 (ng/ml) 1000 600 600 400 200 0 0 24 48 72 96 120 144 168 Time (hours) • Fast absorption2 • Rapid decline2 • Optimal terminal half-life (8 h)1,2 • No accumulation over
Slide 8: Daridorexant is effective and well-tolerated in adults with insomnia disorder
Daridorexant 50 mg is effective and well-tolerated in adults with insomnia disorder Multicentre, randomized, double-blind, placebo-controlled, phase 3 trial 1 Month 3: Sleep latency WASO sTST Daytime functioning (IDSIQ© Sleepiness) 0 0 70 0 improvement improvement improvement Change from Baseline -5
Slide 9: Characterizing daridorexant dose-response in pediatric insomnia patients
Characterizing daridorexant dose-response in pediatric insomnia patients Double-blind, randomized, placebo-controlled, parallel-group, Phase 2 dose-finding study with 32 sites in 6 countries across US and Europe including participants aged ≥10 to <18 years (N = 166) to characterize daridorexant dose
Slide 10: Patient subgroups based on NDD status and neurodevelopmental traits
Patient subgroups based on NDD status and neurodevelopmental traits1,2 No-NDD Group NDD Group n = 79 n = 37 n = 50 Insomnia disorder Insomnia disorder associated with Insomnia disorder associated without associated NDD subthreshold ASD or ADHD traits with NDD • SRS T-score < 55 points • No history o
Slide 11: Key eligibility criteria and endpoints
Key eligibility criteria and endpoints Key inclusion criteria Age: ≥10 to <18 years Primary endpoint: Insomnia disorder: In accordance with ICSD or DSM-5 Change from baseline to Day 1* in PSG TST SDSC: Score >16 on the Difficulty Initiating or Maintaining Sleep domain Group 3: Documented history of
Slide 12: Patient Disposition: Excellent patient retention throughout the 14-day study
Patient Disposition: Excellent patient retention throughout the 14-day study 163 of 166 randomized patients completed the study (98.2 %) 202 Screened Study completion by treatment arm ↓ Daridorexant Only 3 discontinuations overall 166 Placebo 10 mg 25 mg 50 mg Randomized Randomized, N 41 41 42 42 •
Slide 13: Baseline demographics in the overall study population
Baseline demographics in the overall study population Daridorexant Daridorexant Daridorexant Placebo All patients n (%) or mean (SD) 10 mg 25 mg 50 mg n = 41 n = 165 n = 40 n = 42 n = 42 Sex Female 23 (56) 17 (43) 22 (52) 22 (52) 84 (51) Male 18 (44) 23 (58) 20 (48) 20 (48) 81 (49) Age (years) 14.1
Slide 14: Baseline disease characteristics were balanced across treatment groups
Baseline disease characteristics were balanced across treatment groups Daridorexant Daridorexant Daridorexant Placebo All patients 10 mg 25 mg 50 mg n = 41 n = 165 n = 40 n = 42 n = 42 Time since insomnia diagnosis – years 3.6 (3.1) 4.8 (3.7) 4.2 (3.6) 3.7 (3.3) 4.1 (3.4) Sleep symptoms [n (%)] Diff
Slide 15: Daridorexant significantly increased objective TST in a dose-dependent manner
Daridorexant significantly increased objective TST in a dose-dependent manner Primary endpoint - Change from baseline to Day 1 (measured by PSG) 70 Change from baseline in objective TST* (min) 60 50 40 Daridorexant 50 mg increased TST 49.6 min 30 vs. 20.1 min with PBO LSM difference +29.6 min 20 [95
Slide 16: NDD subgroup: Dose-response observed in objective TST
NDD subgroup: Dose-response observed in objective TST Exploratory analysis of the primary endpoint - Change from baseline to Day 1 90 Change from baseline in objective TST* (min) 80 70 60 50 40 Daridorexant 50 mg 30 increased TST 63.8 min vs. 27.2 min with PBO 20 LSM difference +36.3 min [95% CI 3.1
Slide 17: Daridorexant reduced wakefulness at night
Daridorexant reduced wakefulness at night Other endpoints - Change from baseline to Day 1 (WASO* measured by PSG) 10 0 Change from baseline (min) -10 -20 Daridorexant 50 mg reduced WASO -24.5 min vs. -1.5 min with PBO LSM difference -23.1min [95% CI -38.8, -7.3] -30 -40 Placebo Daridorexant Daridore
Slide 18: Daridorexant showed the largest numerical improvement vs. placebo in subjective duration of sleep
Daridorexant 50 mg showed the largest numerical improvement vs. placebo in subjective duration of sleep Other endpoints - Change from baseline to Week 2 in sTST (caregiver-reported) 100 90 Change from baseline in sTST* (min) 80 70 60 Daridorexant 50 mg 50 increased sTST 68.8 min 40 vs. 29.7 min with
Slide 19: Daridorexant improved VAS quality of sleep
Daridorexant 50 mg improved VAS quality of sleep Other outcomes - Change from baseline to Week 2 as assessed by the caregiver* Towards better quality of sleep 19.44 Daridorexant 50mg (n = 35) +6.61 vs PBO** (-2.84,16.05) 12.84 Placebo (n = 31) 0 5 10 15 20 25 Mean change of VAS score (mm) from basel
Slide 20: Daridorexant 50mg reduced morning sleepiness
Daridorexant 50mg reduced morning sleepiness Safety outcomes - Change from baseline to Week 2 as assessed by the caregiver Towards safety signal on next-morning residual effect Towards better alertness/less sleepiness Daridorexant 50mg 20.9 (n = 35) +9.01 vs PBO* (-1.19,19.20) 11.19 Placebo (n = 31)
Slide 21: Daridorexant was well tolerated across all doses, with similar safety profile across treatment groups
Daridorexant was well tolerated across all doses, with similar safety profile across treatment groups Safety outcomes* Placebo Daridorexant 10 mg Daridorexant 25 mg Daridorexant 50 mg n (%) (n = 41) (n = 40) (n = 42) (n = 42) Patients with ≥1 adverse event 10 (24.4) 11 (27.5) 7 (16.7) 10 (23.8) Pati
Slide 22: Conclusions: The dual orexin receptor antagonist daridorexant in pediatric insomnia disorder
Conclusions: The dual orexin receptor antagonist daridorexant in pediatric insomnia disorder • Primary endpoint: Statistically significant dose-dependent improvement in objective total sleep time from baseline to Day 1 (p = 0.0185) – Efficacy was also demonstrated in children with insomnia and NDDs