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Daridorexant, a New Dual Orexin Receptor Antagonist to Treat Insomnia Disorder

Artikel i vetenskaplig tidskrift
Författare Y. Dauvilliers
G. Zammit
I. Fietze
D. Mayleben
D. S. Kinter
S. Pain
Jan A Hedner
Publicerad i Annals of Neurology
Volym 87
Nummer/häfte 3
Sidor 347-356
ISSN 0364-5134
Publiceringsår 2020
Publicerad vid Institutionen för medicin
Sidor 347-356
Språk en
Länkar dx.doi.org/10.1002/ana.25680
Ämnesord combining multiple comparisons, clinical-practice guideline, sleep, efficacy, safety, adults, Neurosciences & Neurology
Ämneskategorier Neurovetenskaper

Sammanfattning

Objective To evaluate the dose-response relationship of daridorexant, a new dual orexin receptor antagonist, on sleep variables in subjects with insomnia disorder. Methods Adults (<= 64 years) with insomnia disorder were randomized (1:1:1:1:1:1) to receive daily oral placebo, daridorexant (5, 10, 25, or 50mg), or 10mg zolpidem for 30 days. The primary efficacy outcome was the change in wake time after sleep onset from baseline to days 1 and 2. Secondary outcome measures were change in latency to persistent sleep from baseline to days 1 and 2, change in subjective wake time after sleep onset, and subjective latency to sleep onset from baseline to week 4. Safety was also assessed. Results Of 1,005 subjects screened, 359 (64% female) were randomized and received >= 1 dose. A significant dose-response relationship (multiple comparison procedure-modeling, 2-sided p < 0.001) was found in the reduction of wake after sleep onset and latency to persistent sleep from baseline to days 1 and 2 with daridorexant. These reductions were sustained through to days 28 and 29 (p = 0.050 and p = 0.042, respectively). Similar dose-dependent relationships were observed for subjective wake after sleep onset and subjective latency to sleep onset. The incidence of treatment-emergent adverse events was 35%, 38%, 38%, and 34% in subjects treated with 5, 10, 25, and 50mg daridorexant, respectively, compared with 30% for placebo, and 40% for 10mg zolpidem. There were no clinically relevant treatment-related serious adverse events. Four subjects withdrew due to adverse events. Interpretation Daridorexant induced a dose-dependent reduction in wake time after sleep onset in subjects with insomnia disorder ( NCT02839200). ANN NEUROL 2020

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