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?
The patient's self-reported sleep quality and quantity
The patient's ability to function during the day
The patient's compliance with the treatment plan
The presence of any side effects
I also consider whether the patient is seeing improvement in their daytime insomnia symptoms. These symptoms can include:
Fatigue
Difficulty concentrating
Irritability
Mood swings
Reduced motivation
Increased risk of accidents
If the patient is not seeing improvement in their daytime insomnia symptoms, I may need to adjust the treatment plan. This could involve changing the type of medication, the dosage, or the frequency of dosing. I may also need to recommend lifestyle changes, such as improving sleep hygiene or reducing stress levels.
just a thorough review of systems