Idorsia has enrolled the first patients in a study intended to support a QUVIVIQ label update in the United States, where the company wants prescribing information to include the insomnia drug’s effects on daytime functioning. The Swiss drugmaker announced the enrollment on October 27, 2026.

Key Takeaways

  • The Phase 3 Dari-Dream study will compare a 50 mg dose of QUVIVIQ with a placebo.
  • The trial’s primary endpoint is subjective total sleep time; daytime symptoms are among its secondary measures.
  • Idorsia expects results during 2028.

QUVIVIQ label update depends on further evidence

Idorsia said it designed the Dari-Dream study after discussions with the US Food and Drug Administration to further characterize daytime outcomes and support their inclusion in US prescribing information. The announcement does not establish that a label change has been approved.

The company said its earlier Phase 3 program found improvements with the 50 mg dose across measures of alertness and cognition, mood and sleepiness. It said those findings are reflected in prescribing information in multiple countries, including across Europe.

How the new study will work

Dari-Dream is a randomized, double-blind, placebo-controlled study in adults and older people with insomnia disorder. Approximately 344 participants are to be assigned to receive either 50 mg of QUVIVIQ, also known as daridorexant, or a placebo once nightly for three months.

The primary endpoint will measure changes in subjective total sleep time. Key secondary endpoints include the sleepiness domain and total score of the Insomnia Daytime Symptoms and Impacts Questionnaire, which assesses daytime consequences of insomnia.

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