{
  "abstract": "The prevalence of obstructive sleep apnea (OSA) in patients with insomnia disorder (ID) is ~30%-40%. Daridorexant 50 mg improved both sleep and daytime functioning in patients with ID and did not impair nighttime respiratory function in patients with OSA. This post-hoc analysis investigates the effects of daridorexant in patients with comorbid ID and untreated mild OSA.This analysis evaluates efficacy and safety of daridorexant 50 mg versus placebo, in a subgroup of participants with ‘mild OSA’ (AHI: 5–<15 events per hour) at screening from the 3-month Phase 3 trial (NCT03545191). Endpoints assessed at Month (M) 1 and M3 include PSG measured wake after sleep onset (WASO) and latency to persistent sleep (LPS), as well as Epworth Sleepiness Scale© (ESS©), visual analog scale (VAS) morning sleepiness and treatment-emergent adverse events (TEAEs)..Of 930 randomized participants, 153(17%) had mild OSA (daridorexant: 50 mg: n=53, 25 mg: n=53; placebo: n=47). Participants with mild OSA versus no OSA were older, had a higher male proportion, a higher BMI, and longer baseline WASO (114.2 [40.8] versus 95.5 [38.1] min). In participants with mild OSA at baseline, LPS was 64.9 (36.8) min, ESS© was 6.4 (5.2) and VAS morning sleepiness was 42.8 (20.0). Daridorexant 50 mg versus placebo improved WASO and LPS. ESS© scores remained unchanged from baseline to M1 and M3 for daridorexant 50 mg and placebo. Daridorexant 50 mg reduced morning sleepiness to a greater extent than placebo. TEAE incidence was 45.3% (daridorexant 50 mg) and 38.3% (placebo). Two participants discontinued study treatment due to AEs (both in placebo). One participant reported somnolence (daridorexant 50 mg).Daridorexant 50 mg improved sleep among patients with comorbid insomnia and untreated mild OSA with an acceptable safety profile.Funding This study was funded by Idorsia Pharmaceuticals Ltd",
  "authors": [
    {
      "affiliations": [
        "Idorsia Pharmaceuticals UK Ltd, London, United Kingdom"
      ],
      "name": "Alistair Paice"
    },
    {
      "affiliations": [
        "Idorsia Pharmaceuticals US Ltd, Radnor, United States",
        "Pulmonary, Critical Care and Sleep Medicine, Department of Medicine, Uniformed Services University, Bethesda, United States"
      ],
      "name": "Christopher Lettieri"
    },
    {
      "affiliations": [
        "Université Paris Cité- HOTEL-DIEU de Paris APHP-Centre Université Paris Cité, Paris, France"
      ],
      "name": "Damien Léger"
    },
    {
      "affiliations": [
        "Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland"
      ],
      "name": "Pierre-Phillippe Luyet"
    },
    {
      "affiliations": [
        "Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of California, San Diego, United States"
      ],
      "name": "Atul Malhotra"
    },
    {
      "affiliations": [
        "Institut National de la Sante et de la Recherche Medicale (INSERM) U , HP Laboratory (Hypoxia: Pathophysiology), Grenoble Alpes University, Grenoble, France"
      ],
      "name": "Jean-Louis Pépin"
    },
    {
      "affiliations": [
        "Division of Sleep and Circadian Disorders, Department, Harvard Medical School of Medicine, Brigham and Women’s Hospital and Division of Sleep Medicine, Harvard Medical School, Boston, United States"
      ],
      "name": "Stuart Quan"
    },
    {
      "affiliations": [
        "Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of California, San Diego, United States"
      ],
      "name": "Janna Raphelson"
    },
    {
      "affiliations": [
        "Idorsia Pharmaceuticals US Ltd, Radnor, United States"
      ],
      "name": "Paul Saskin"
    },
    {
      "affiliations": [
        "Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland"
      ],
      "name": "Oresitis Briasoulis"
    }
  ],
  "title": "P3 Effect of daridorexant on patients with comorbid insomnia disorder and untreated mild obstructive sleep apnea: a post-hoc analysis of a phase 3 study",
  "uid": "43cb75c3-be85-5aed-abe3-504e841a5caa"
}