Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2024 Oct:122:64-70.
doi: 10.1016/j.sleep.2024.07.036. Epub 2024 Aug 7.

Long-term safety and efficacy of daridorexant in Japanese patients with insomnia disorder

Naohisa Uchimura  1 , Motohiro Ozone  2 , Masahiro Suzuki  3 , Mitsutaka Taniguchi  4 , Kenichi Kuriyama  5 , Osamu Togo  6 , Makoto Uchiyama  7
Affiliations
Free article
Clinical Trial

Long-term safety and efficacy of daridorexant in Japanese patients with insomnia disorder

Naohisa Uchimura et al. Sleep Med. 2024 Oct.
Free article

Abstract

Objective/background: The short-term efficacy and safety of daridorexant, a dual orexin receptor antagonist, has been demonstrated in Japanese patients with insomnia disorder. The objective of this study was to evaluate, in a non-overlapping patient population to the short-term study, the long-term safety and efficacy of daridorexant in Japanese patients with insomnia disorder.

Patients/methods: In this Phase 3 open-label study conducted in Japan, 154 patients with insomnia disorder were randomized to daridorexant 50 mg (n = 102) or 25 mg (n = 52) for 52 weeks. The primary objective was to assess the safety and tolerability of daridorexant for up to 1 year. Secondary exploratory objectives were to evaluate the long-term efficacy of daridorexant on subjective sleep parameters (total sleep time, latency to sleep onset and wake after sleep onset) and daytime functioning (Insomnia Daytime Symptoms and Impacts Questionnaire).

Results: The incidence of treatment-emergent adverse events (TEAEs) was 74 % and 58 % in the 50 mg and 25 mg groups respectively. No serious drug-related TEAEs were reported. Both doses improved next-morning sleepiness (Visual Analog Scale) throughout the study. Five adjudicated adverse events of special interest were reported; excessive daytime sleepiness (n = 1, 25 mg; n = 2, 50 mg), sleep paralysis (n = 1, 50 mg) and nightmare (n = 1, 25 mg). Improvements in sleep and daytime functioning were maintained from Week 2 (first assessment) through to Week 52 in both dose groups.

Conclusions: Up to 52-weeks, daridorexant was well tolerated with sustained improvement in sleep onset, sleep maintenance and daytime functioning, supporting its long-term use in Japanese patients with insomnia disorder.

Keywords: Daridorexant; Efficacy; IDSIQ; Insomnia; Japan; Long-term; Safety.

PubMed Disclaimer

Conflict of interest statement

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: All authors report financial support, administrative support, and writing assistance were provided by Nxera Pharma Japan Co., Ltd. All authors reports financial support was provided by Mochida Pharmaceutical Co Ltd. Naohisa Uchimura reports a relationship with Eisai Co Ltd that includes: speaking and lecture fees. Naohisa Uchimura reports a relationship with MSD KK that includes: speaking and lecture fees. Motohiro Ozone reports a relationship with Eisai Co Ltd that includes: speaking and lecture fees. Motohiro Ozone reports a relationship with MSD KK that includes: speaking and lecture fees. Motohiro Ozone reports a relationship with Takeda Pharmaceutical Company Limited that includes: speaking and lecture fees. Motohiro Ozone reports a relationship with Tsumura & Co that includes: speaking and lecture fees. Masahiro Suzuki reports a relationship with EA Pharma Co Ltd that includes: funding grants and speaking and lecture fees. Masahiro Suzuki reports a relationship with Eisai Co Ltd that includes: funding grants, paid expert testimony, and speaking and lecture fees. Masahiro Suzuki reports a relationship with Mochida Pharmaceutical Co Ltd that includes: funding grants, paid expert testimony, and speaking and lecture fees. Masahiro Suzuki reports a relationship with Meiji Co Ltd that includes: funding grants and speaking and lecture fees. Masahiro Suzuki reports a relationship with Otsuka Pharmaceutical Co Ltd that includes: funding grants and speaking and lecture fees. Masahiro Suzuki reports a relationship with Shionogi and Co Ltd that includes: funding grants and speaking and lecture fees. Masahiro Suzuki reports a relationship with Sumitomo Pharma Co Ltd that includes: funding grants and speaking and lecture fees. Masahiro Suzuki reports a relationship with Kao Corporation that includes: paid expert testimony and speaking and lecture fees. Masahiro Suzuki reports a relationship with Kyowa Pharmaceutical Industry Co Ltd that includes: speaking and lecture fees. Masahiro Suzuki reports a relationship with Takeda Pharmaceutical Company Limited that includes: speaking and lecture fees. Masahiro Suzuki reports a relationship with Viatris Inc that includes: speaking and lecture fees. Masahiro Suzuki reports a relationship with Yoshitomi Pharmaceutical Corporation that includes: speaking and lecture fees. Masahiro Suzuki reports a relationship with Jazz Pharmaceuticals Inc that includes: paid expert testimony. Kenichi Kuriyama reports a relationship with Otsuka Pharmaceutical Co Ltd that includes: funding grants. Kenichi Kuriyama reports a relationship with Eisai Co Ltd that includes: consulting or advisory, funding grants, and speaking and lecture fees. Kenichi Kuriyama reports a relationship with MSD KK that includes: funding grants and speaking and lecture fees. Kenichi Kuriyama reports a relationship with Takeda Pharmaceutical Company Limited that includes: funding grants and speaking and lecture fees. Kenichi Kuriyama reports a relationship with Meiji Co Ltd that includes: speaking and lecture fees. Kenichi Kuriyama reports a relationship with Yoshitomi Pharmaceuical Corporation that includes: speaking and lecture fees. Kenichi Kuriyama reports a relationship with Sumitomo Pharma Co Ltd that includes: speaking and lecture fees. Kenichi Kuriyama reports a relationship with Aculys Pharma, LLC. that includes: speaking and lecture fees. Kenichi Kuriyama reports a relationship with Nobelpharma Co Ltd that includes: speaking and lecture fees. Kenichi Kuriyama reports a relationship with Nxera Pharma Japan Co Ltd that includes: consulting or advisory. Osamu Togo reports a relationship with Nxera Pharma Japan Co. Ltd that includes: employment. Makoto Uchiyama reports a relationship with Nxera Pharma Japan Co. Ltd that includes: consulting or advisory. Makoto Uchiyama reports a relationship with LIXIL Corporation that includes: consulting or advisory. Makoto Uchiyama reports a relationship with Taisho Pharmaceutical Co Ltd that includes: consulting or advisory.

Publication types

LinkOut - more resources