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P4 Daridorexant improves total sleep time (TST) in insomnia patients without altering the proportion of sleep stages
  1. James Khoo1,
  2. Gary Zammit2,
  3. David Mayleben3,
  4. Ingo Fietze4,
  5. Scott Pain5,
  6. Alberto Gimona5,
  7. Dalma Seboek Kinter5 and
  8. Yves Dauvilliers6
  1. 1Idorsia Pharmaceuticals Ltd, London, UK
  2. 2Clinilabs Inc., New York, USA
  3. 3CTI Clinical Research Center, Cincinnati, USA
  4. 4Center for Sleep Medicine, Charité – University Hospital Berlin, Berlin, Germany
  5. 5Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland
  6. 6Unité du Sommeil, Département de Neurologie, Hôpital Gui-de-Chauliac, Université Montpellier, INSERM 1061, Montpellier, France


Daridorexant, a dual orexin receptor antagonist, improved sleep parameters and daytime functioning in two pivotal Phase 3 trials in patients with insomnia (Trial-1, NCT03545191; Trial-2, NCT03575104). We report the effects of daridorexant on TST and sleep stages from both trials.

Eligible patients with insomnia (DSM-5 criteria) were randomized (1:1:1) in Trial-1 (N=930) to daridorexant 25mg, 50mg, or placebo and in Trial-2 (N=924) to daridorexant 10mg, 25mg, or placebo. Oral treatment was administered each night during a 3-month double-blind treatment period. Assessment of TST and sleep stages (non-rapid eye movement [NREM], N1, N2, N3, REM), measured by polysomnography in sleep laboratory, was performed on two consecutive nights during single-blind placebo run-in (baseline) and Months 1 and 3 (M1 and M3) of double-blind treatment. Change from baseline in TST and sleep stages were exploratory endpoints in both trials. Data for M3 (mean ± standard deviation) are presented as change from baseline.

Daridorexant dose-dependently increased TST(minutes) from baseline to M3 versus placebo in Trial-1 (25mg, 55±56; 50mg, 61±53; placebo, 40±56) and Trial-2 (10mg, 37±57; 25mg, 50±53; placebo, 35±56).

In both trials, sleep stage proportions were preserved from baseline to M3, with no relevant changes in any group. Baseline time spent in each sleep stage (% of TST) was consistent across groups in both trials. In Trial-1, the change from baseline to M3 in% of TST spent in N1-N3, and REM was low and numerically similar across treatments. In Trial-2, change from baseline to M3 in% of TST spent in each sleep stage was consistent with Trial-1, with no dose effect. Mean changes from baseline (% of TST) for each sleep stage appeared to be independent from increasing TST.

Daridorexant versus placebo increased TST in a dose-dependent manner without affecting the proportion of sleep stages in patients with insomnia.

Support: Idorsia Pharmaceuticals Ltd.

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