{
  "abstract": "Introduction Daridorexant is a dual orexin receptor antagonist approved for the treatment of adult patients with chronic insomnia. Following single-dose administration at bedtime to healthy subjects, pharmacodynamics and safety were investigated in the middle of the night after forced awakening.Methods Double-blind, placebo-controlled, randomized, 3-way crossover study (placebo, 25, and 50 mg daridorexant in the evening) in 36 male and female non-elderly and elderly subjects. Four h post-bedtime administration, the auditory awakening threshold (AAT) was determined. postural stability (body sway) as well as basic functional mobility (Timed Up and Go (TUG) test), and cognitive function/memory using the Visual Verbal Learning Test (VVLT) were also assessed.Results The average AAT was approximately 60 dB across treatments with no differences between daridorexant and placebo. Body sway showed a small, dose-dependent increase vs placebo with differences in least square means. driven by non-elderly subjects,. Subjects completed the TUG test in 6–8 s across treatments, with a small, dose-dependent increase vs placebo. The VVLT showed minimal differences to for daridorexant 25 and 50 mg, respectively.Conclusion Following bedtime administration, daridorexant preserved the ability to respond to external noise stimuli and subjects were able to operate safely during the night.eleanor.owen-jones@idorsia.com",
  "authors": [
    {
      "affiliations": [
        "Idorsia Pharmaceuticals UK Ltd, London, UK"
      ],
      "name": "Owen-jones Eleanor"
    },
    {
      "affiliations": [
        "Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, 4123 Allschwil, Switzerland"
      ],
      "name": "Muehlan Clemens"
    },
    {
      "affiliations": [
        "Centre for Human Drug Research (CHDR), Zernikedreef 8, 2333 CL Leiden, The Netherlands"
      ],
      "name": "Koopman Ingrid"
    },
    {
      "affiliations": [
        "Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, 4123 Allschwil, Switzerland",
        "Centre for Human Drug Research (CHDR), Zernikedreef 8, 2333 CL Leiden, The Netherlands"
      ],
      "name": "Magliocca Massimo"
    },
    {
      "affiliations": [
        "Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, 4123 Allschwil, Switzerland"
      ],
      "name": "Vaillant Cedric"
    },
    {
      "affiliations": [
        "Centre for Human Drug Research (CHDR), Zernikedreef 8, 2333 CL Leiden, The Netherlands"
      ],
      "name": "Zuiker Rob"
    },
    {
      "affiliations": [
        "Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, 4123 Allschwil, Switzerland"
      ],
      "name": "Dingemanse Jasper"
    }
  ],
  "title": "6 Nighttime safety of daridorexant: response to noise stimuli, effects on postural stability, walking and memory",
  "uid": "61ba9a99-826a-5626-8ad2-77439581d34c"
}