Daridorexant, a new dual orexin receptor antagonist, in elderly subjects with insomnia disorder
To assess the dose-response of daridorexant, a new dual orexin receptor antagonist, on wake after sleep onset (WASO). Elderly (≥65 years) participants (n = 58) with insomnia were randomly allocated (Latin square design) to receive 5 treatments (5, 10, 25, and 50 mg daridorexant and placebo) during 5...
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| Vydáno v: | Neurology Ročník 94; číslo 21; s. e2222 |
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| Hlavní autoři: | , , , , , |
| Médium: | Journal Article |
| Jazyk: | angličtina |
| Vydáno: |
United States
26.05.2020
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| ISSN: | 1526-632X, 1526-632X |
| On-line přístup: | Zjistit podrobnosti o přístupu |
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| Shrnutí: | To assess the dose-response of daridorexant, a new dual orexin receptor antagonist, on wake after sleep onset (WASO).
Elderly (≥65 years) participants (n = 58) with insomnia were randomly allocated (Latin square design) to receive 5 treatments (5, 10, 25, and 50 mg daridorexant and placebo) during 5 treatment periods, each consisting of 2 treatment nights followed by a 5- to 12-day washout period. Main efficacy endpoints were the absolute change from baseline in WASO (primary) and latency to persistent sleep (LPS; secondary) to days 1 and 2 (mean of 2 treatment nights assessed by polysomnography) in each period. Safety and tolerability were also assessed.
Of 58 participants included, 67% were female, and the median age was 69 years (range 65-85 years). WASO and LPS were dose-dependently reduced from baseline to days 1 and 2 after daridorexant administration (multiple comparison procedure modeling,
< 0.0001 and
= 0.004, respectively); reductions were statistically significant for doses ≥10 mg compared with placebo (WASO: -32.0, -45.1, -61.4 minutes; LPS: -44.9, -43.8, -45.4 minutes for 10, 25, and 50 mg, respectively,
≤ 0.025). Treatment-emergent adverse events were similar for daridorexant and placebo; the most frequent were fatigue, nasopharyngitis, gait disturbance, and headache (≤7% in any group).
Daridorexant was well tolerated. Dose-dependent improvements in WASO and LPS were statistically significant (dose range 10-50 mg) in elderly people with insomnia disorder.
NCT02841709.
This study provides Class I evidence that, for elderly people with insomnia, daridorexant reduced WASO. |
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| Bibliografie: | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-Undefined-3 |
| ISSN: | 1526-632X 1526-632X |
| DOI: | 10.1212/WNL.0000000000009475 |