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.

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.

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.

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.

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.