Idorsia reports positive results for daridorexant in chronic insomnia and nocturia patients

A recent study published in the Journal of Sleep Research highlights the efficacy of Idorsia's dual orexin receptor antagonist, daridorexant, in treating patients with chronic insomnia coupled with nocturia. This Phase 4 trial, conducted as a placebo-controlled study, provides significant insights into how daridorexant can effectively manage both insomnia and nocturia symptoms, particularly in individuals aged 55 and older. The study confirms that daridorexant is safe and well-tolerated, aligning with its established safety profile from prior Phase 3 studies on chronic insomnia.

Chronic insomnia, characterized by difficulties in starting or maintaining sleep at least three times a week for over three months, significantly impacts daily functioning. Nocturia, defined as waking up during the night to urinate, often coexists with insomnia, especially in older adults, contributing to poor sleep quality and diminished daytime performance.

The study involved 60 participants, evenly divided between men and women, all over the age of 55, suffering from both insomnia and nocturia. This multinational, multicenter trial was designed as a double-blind, randomized, placebo-controlled, two-way crossover study. It included two treatment periods of four weeks each, separated by a 2-3-week washout phase.

Participants received a daily dose of 50 mg of daridorexant, which significantly improved subjective total sleep time (sTST) and various aspects of sleep and daytime functioning by the fourth week. The Insomnia Severity Index (ISI) score showed a marked reduction, with a higher proportion of patients on daridorexant improving by six or more units compared to those on placebo, a threshold for clinical significance. Improvements in sleep quality, depth, and daytime functionality were noted as early as the first week and were sustained throughout the treatment period.

Moreover, treatment with daridorexant reduced the frequency of nocturnal voids and improved other nocturia-related symptoms, such as delaying the time to the first void. A shorter time to first void is linked with increased daytime dysfunction and decreased sleep quality and efficiency. Notably, no serious adverse events or discontinuations due to adverse effects were recorded, and crucially, no incidents of urinary incontinence or falls were observed among participants.

The study's findings are promising for those suffering from both chronic insomnia and nocturia. Dr. Katharina Lederer, the coordinating investigator from Advanced-Sleep-Research GmbH in Berlin, emphasized the remarkable results, highlighting the consistent efficacy across insomnia metrics, including extended total sleep time and significant insomnia severity reduction. The treatment also led to improved daytime functioning, with patients expressing higher satisfaction compared to those on placebo.

Dr. José Emilio Batista, a study investigator from Spain, highlighted the severe nocturia symptoms faced by participants, noting how the study demonstrated that patients could sleep longer before needing to urinate, reducing the number of toilet visits during the night. These outcomes are considered clinically meaningful, offering hope for improved management of these intertwined conditions.

In addition to the clinical insights, the publication of this study aligns with World Sleep Day, a global initiative emphasizing the importance of sleep health. Chronic sleep disorders, such as insomnia, are often underestimated despite their significant impact on daily life. The research underscores the need for increased awareness and effective treatment options for such prevalent conditions.