Insomnia impairs daytime functioning, presenting as fatigue, sleepiness, cognitive impairment, and more. Traditional sleep treatments have focused on the ability to address nighttime sleep, with little data demonstrating improvements in daytime functioning. Daridorexant clinical trials were designed to include patient-reported outcomes related to daytime functioning.

In addition to nighttime efficacy endpoints to evaluate the effect of 50 mg daridorexant on sleep, a secondary efficacy endpoint was included to evaluate effect on daytime insomnia symptoms. This was measured using the Insomnia Daytime Symptoms and Impact Questionnaire (IDSIQ). IDSIQ is the first patient-reported outcome tool that was developed/validated per FDA guidelines that can measure impact on daytime symptoms related to insomnia, such as mental and physical tiredness, energy levels, and more. This diagnostic tool includes 14 items across 3 domains: sleepiness, mood, and alert/cognition.

In clinical trials, when 50 mg daridorexant was taken every night, it demonstrated statistically significant reduction in daytime sleepiness vs placebo. In addition to achieving the secondary efficacy endpoint of reduced daytime insomnia symptoms, low rates of next-day somnolence and fatigue were reported as part of the QUVIVIQ safety profile. Adverse reaction rates in those taking 50 mg daridorexant every night for 12 months were comparable with those taking placebo.

How do you evaluate whether your patient’s treatment is providing sufficient efficacy? Do you consider whether your patient is seeing improvement in their daytime insomnia symptoms?