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Study to Determine Safe and Effective Dose of Daridorexant for Treating Insomnia in Children and Adolescents Aged 10 to 18 Years

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Insomnia Disorder in children and adolescents aged 10 to under 18 years. The treatment being tested is a medication called daridorexant, which is taken in the form of film-coated tablets. The study aims to find out which dose of daridorexant is safe and effective for treating insomnia in this age group. Participants in the study will receive either the medication or a placebo, which looks like the medication but does not contain the active substance.

The purpose of the study is to understand how different doses of daridorexant affect sleep in young people with insomnia. The study will involve multiple doses of the medication, and participants will be monitored to see how their sleep changes over time. This will be done using a method called polysomnography, which is a type of sleep study that records brain waves, oxygen levels, heart rate, and breathing during sleep.

Participants will take the medication or placebo for a period of up to 20 days. The study will help determine the best dose of daridorexant for improving sleep in children and adolescents with insomnia. The results will provide valuable information on the safety and effectiveness of this treatment for young people struggling with sleep difficulties.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be required to provide a signed and dated informed consent form from their caregiver, such as a parent or legal guardian. Additionally, the patient must provide written assent if they are of an appropriate age to do so.

    The patient must be between 10 and 18 years old and have a diagnosis of chronic insomnia disorder according to specific criteria. This includes difficulty with sleep that has persisted for at least three months and occurs at least three nights per week.

  2. Step 2

    Screening period

    During the screening period, the patient will undergo polysomnography (PSG), a type of sleep study, on two separate nights. This will help establish a baseline for the patient's total sleep time (TST).

    The patient must have a Sleep Disturbance Scale for Children (SDSC) score greater than 16 in the Difficulty Initiating or Maintaining Sleep domain.

  3. Step 3

    Randomization and treatment

    The patient will be randomly assigned to receive either QUVIVIQ 25 mg or 50 mg film-coated tablets, or a placebo. The medication is taken orally.

    The treatment aims to assess the efficacy and safety of daridorexant in improving sleep in children and adolescents with insomnia.

  4. Step 4

    Treatment period

    On the first day of the treatment period, the patient will undergo another PSG to measure changes in total sleep time from the baseline established during the screening period.

    The treatment will continue as per the study's schedule, with regular monitoring to ensure safety and effectiveness.

  5. Step 5

    End of treatment

    The study is expected to conclude by April 30, 2025. The patient will be monitored until the end of the treatment period, with follow-up assessments as necessary.

    The patient may be required to undergo additional urine pregnancy tests if applicable, up to five days after discontinuing the study treatment.

Who can join the trial?

9 criteria

  • A signed and dated informed consent form from the caregiver, such as a parent or legal guardian, is required before any study procedures begin.
  • Written agreement (assent) from the child, if they are old enough to understand and agree, is needed.
  • The child must be between 10 and 18 years old at the time of signing the consent form.
  • The child must have **chronic insomnia disorder**, which means they have trouble falling asleep, staying asleep, or waking up too early and can't go back to sleep. This must have been happening for at least 3 months, at least 3 nights a week, and despite trying good sleep habits or other non-medication treatments.
  • The sleep problem should not be caused by any medication the child is taking, as judged by the study doctor.
  • The child or caregiver must report that the sleep problem affects the child's daytime activities.
  • The child must have a certain score on a sleep disturbance questionnaire, indicating difficulty in starting or maintaining sleep.
  • If the child is a female who can have children, she must have a negative pregnancy test before starting the study and agree to take pregnancy tests during the study. She must also agree to use effective birth control during the study and for a short time after.
  • If the child has a **neurodevelopmental disorder** like autism or ADHD, this must be documented in their medical records. They can continue taking certain medications for these conditions if they have been stable for at least 4 weeks before the study and are expected to remain stable during the study.
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Investigated drugs

Daridorexant is a medication being studied for its effects on sleep in children and teenagers with insomnia. It is taken by mouth and is being tested to see how well it helps improve total sleep time. The study aims to find the best dose that helps increase sleep duration safely.

What is already known about the treatment

Daridorexant – This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating insomnia disorder, particularly in pediatric patients aged 10 to under 18 years. It is a relatively new substance in medical literature, primarily being evaluated for its safety and efficacy. The main therapeutic indication for daridorexant is to improve sleep duration and quality in individuals with insomnia. At the molecular level, daridorexant works by blocking orexin receptors, which play a role in wakefulness, thereby promoting sleep. It is classified pharmacologically as an orexin receptor antagonist.

Investigated diseases

Insomnia Disorder – Insomnia disorder is a condition characterized by difficulty falling asleep, staying asleep, or waking up too early and not being able to return to sleep. This disorder can lead to daytime fatigue, mood disturbances, and difficulty concentrating. It often results from stress, irregular sleep schedules, or environmental factors. Over time, insomnia can become chronic, persisting for months or longer. The disorder can affect people of all ages, including children, and may vary in severity. It is important to address underlying causes to improve sleep quality.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IITrial ID2024-513885-20-00Protocol codeID-078A205Estimated enrolment150 patientsSponsorIdorsia Pharmaceuticals Ltd.

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