Idorsia seeks US label update for QUVIVIQ daytime functioning benefits – first patients enrolled in Dari-Dream

Insomnia disorder is a chronic, 24-hour condition that impacts not only sleep at night but also how people feel and function during the day. Beyond difficulties falling or staying asleep, people with insomnia experience symptoms that affect alertness, cognition, mood, energy, and daily functioning.

QUVIVIQ is supported by an extensive body of clinical evidence demonstrating not only benefits across nighttime symptoms of insomnia, but also daytime functioning. In the Phase 3 program, meaningful improvement with the 50 mg dose was observed across all three IDSIQ domains of alert/cognition, mood, and sleepiness as well as the overall IDSIQ score. These findings are reflected in prescribing information in multiple countries worldwide, including across Europe.

Following discussions with the US Food and Drug Administration, Dari-Dream has been specifically designed to further characterize these outcomes and support their inclusion in US prescribing information. Inclusion of daytime functioning information in the US label would support broader physician and patient education on an aspect of insomnia treatment that is highly relevant to people living with the disorder.

Amer Joseph, MD, Chief Medical Officer and Head of Global Clinical Development at Idorsia commented: “Insomnia is a 24-hour condition that affects patients both during the night and throughout the following day. Daridorexant was specifically designed to provide efficacy across the night while minimizing next-morning residual sleepiness. Importantly, its differentiated profile as an equipotent dual orexin receptor antagonist may also contribute directly to improvements in daytime functioning. Building on the extensive evidence generated during the clinical development program, Dari-Dream is designed to further characterize these outcomes and support their inclusion in US prescribing information.”

Roland Wandeler, Chief Executive Officer of Idorsia, commented: "For people living with insomnia, the burden of the condition extends well beyond the night. Difficulties with alertness, mood, energy, and daily functioning can affect many aspects of everyday life. We have already generated compelling evidence demonstrating the benefits of daridorexant not only on sleep, but also daytime functioning. Dari-Dream is an important next step in our efforts to make this information available to healthcare professionals and patients in the US. Together with other initiatives aimed at enhancing the patient and physician experience, Dari-Dream forms part of our broader strategy to maximize the potential of QUVIVIQ for patients."

For further information, please contact:

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