Daridorexant for Pediatric Insomnia

Recruiting at 30 trial locations

Overseen By Clinical Trial Information Europe

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Idorsia Pharmaceuticals Ltd.

Must be taking: CNS stimulants

Disqualifiers: Sleep apnea, Narcolepsy, Bipolar, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 3 days

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a medication called daridorexant to determine if it helps children and teens with insomnia, which involves difficulty falling or staying asleep. Researchers aim to learn if this medication is safe and effective for those experiencing sleep problems at least three times a week for over three months. Participants will receive either daridorexant or a placebo (a pill with no active medicine) to compare effects. Children aged 10 to under 18 who experience sleep troubles affecting their daytime activities might be suitable for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are using CNS stimulants (medications that affect the central nervous system), you can continue them if they were started at least 4 weeks before the trial and remain stable during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that daridorexant might be a safe treatment for insomnia in adults, including those over 65. Studies have found it is generally well-tolerated in these groups. While the safety of daridorexant for children remains unknown, earlier research in adults suggests potential safety. This trial is in an early stage, focusing on safety and how the body processes the drug. Although early results in adults are encouraging, this trial aims to determine its safety for children. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for insomnia?

Most treatments for pediatric insomnia involve behavioral therapy or medications like melatonin and antihistamines. But Daridorexant works differently, targeting the orexin system, which regulates wakefulness and sleep. This unique mechanism of action helps promote sleep without the grogginess often associated with traditional insomnia medications. Researchers are excited about Daridorexant because it offers a more targeted approach, potentially leading to better sleep quality and fewer side effects for children struggling with insomnia.

What evidence suggests that daridorexant might be an effective treatment for pediatric insomnia?

Studies have shown that daridorexant helps people with insomnia sleep better. In earlier research, patients taking daridorexant reported much better sleep quality, and the treatment proved generally safe and easy to handle. Long-term studies show that improvements in both night-time and daytime symptoms of insomnia persist, especially with higher doses. In this trial, participants will receive either a placebo or one of the experimental doses of daridorexant (10 mg, 25 mg, or 50 mg). The 25 mg and 50 mg doses are considered to offer more benefits than risks from a patient's perspective. This suggests that daridorexant could improve sleep in people with insomnia, including children and teens. ^{1 6 7 8 9}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Idorsia Pharmaceuticals Ltd.

Are You a Good Fit for This Trial?

This trial is for children and teenagers aged 10 to less than 18 years with chronic insomnia, which means they've had trouble sleeping for at least three months. They should have difficulty sleeping at least three nights a week despite good sleep opportunities. The study excludes those under 25 kg, who nap a lot during the day, or have other sleep disorders or significant medical conditions.

Inclusion Criteria

Adolescent of Child-Bearing Potential (AoCBP): Negative serum pregnancy test at Screening and a negative urine pregnancy test at Randomization, Agreement to undertake urine pregnancy tests during the study, as per the schedule of activities and up to 5 days after study treatment discontinuation, Agreement to use an acceptable effective method of contraception from Screening up to 5 days after study treatment discontinuation, Inclusion criteria applicable only to a subset of children with insomnia and comorbid neurodevelopmental disorder: Must have a documented history of NDD (including ASD or ADHD) according to DSM-5 criteria, as confirmed by review of medical records, at Screening. Use of CNS stimulants is allowed if started at least 4 weeks prior to Screening, stable and expected to remain stable during the study until EOT. CNS stimulants are recommended to be taken in the morning

I have had trouble sleeping for over 3 months, affecting my daily life.

I am between 10 and 17 years old.

Exclusion Criteria

I have been diagnosed with a sleep disorder like restless legs or narcolepsy.

Any of the following conditions related to suicidality: Any suicidal ideation with intent, with or without a plan at Screening, i.e., answering 'Yes' to questions 4 or 5 on the suicidal ideation section of the lifetime (Visit 1) and visit (Visit 2) version of the C-SSRS©. Participants who answer 'yes' to any of these questions must be referred to the investigator for follow-up evaluation, History of suicide attempt on the suicidal behavior section of the lifetime version of the C-SSRS© at Visit 1, Any acute or unstable significant medical condition (e.g., seizure disorder, bipolar disorder, schizophrenia), hematology/biochemistry test results, ECG results deviating from the normal ranges to a clinically relevant extent that would preclude participation in the study or could prevent the subject from complying with study requirements, as per investigator judgement, Cognitive behavior therapy (CBT) for any indication is allowed only if it has been started at least 1 month prior to Visit 2 and is kept stable throughout the study

I have a history of sleep-related breathing disorders, but I'm still eligible if treated by tonsillectomy/adenoidectomy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

2 visits (in-person)

Treatment

Participants receive multiple-dose oral administration of daridorexant or placebo

3 days

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Daridorexant
• Placebo

Trial Overview The trial is testing different doses of Daridorexant (10 mg, 25 mg, and 50 mg) against a placebo to see how well it works and its safety in young people with insomnia. Participants will take the medication orally over multiple doses to assess its effects on their sleep issues.

How Is the Trial Designed?

Group I: Daridorexant 50 mg Experimental Treatment 1 Intervention

Group II: Daridorexant 25 mg Experimental Treatment 1 Intervention

Group III: Daridorexant 10 mg Experimental Treatment 1 Intervention

Group IV: Placebo Placebo Group 1 Intervention

Daridorexant is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Quviviq for:

• Insomnia

Approved in European Union as Quviviq for:

• Insomnia

Approved in Canada as Quviviq for:

• Insomnia

Who Is Running the Clinical Trial?

Idorsia Pharmaceuticals Ltd.

Lead Sponsor

Trials

124

Recruited

36,400+

Antonio Olivieri

Idorsia Pharmaceuticals Ltd.

Chief Medical Officer since 2024

Not specified

André C. Muller

Idorsia Pharmaceuticals Ltd.

Chief Executive Officer

Not specified

Published Research Related to This Trial

Daridorexant, a dual orexin receptor antagonist, has been approved in the USA for treating insomnia in adults, showing effectiveness in helping with both sleep onset and maintenance.

The drug is designed to have a duration of action of about 8 hours with a half-life that reduces the risk of daytime drowsiness, making it safer for daily functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daridorexant: First Approval. Markham, A.[2022]

In a study involving 36 healthy subjects, daridorexant, a dual orexin receptor antagonist for insomnia, showed no significant QT interval prolongation at both therapeutic (50 mg) and supratherapeutic (200 mg) doses, indicating it does not impair cardiac repolarization.

The study confirmed daridorexant's safety and tolerability, with pharmacokinetics consistent with previous findings, supporting its potential as a safe treatment option for insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Daridorexant, a Dual Orexin Receptor Antagonist, on Cardiac Repolarization Following Bedtime Dosing: Results from a Thorough QT Study Using Concentration-QT Analysis. Schilling, U., Henrich, A., Muehlan, C., et al.[2021]

Daridorexant (Quviviq™) is an effective treatment for insomnia, improving sleep onset and overall sleep quality in both younger and older adults, as demonstrated in phase 3 clinical trials.

The drug was generally well tolerated, with adverse events similar to or slightly higher than placebo, and no new safety concerns were identified during a 12-month extension trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daridorexant in Insomnia Disorder: A Profile of Its Use. Nie, T., Blair, HA.[2023]

Daridorexant has been shown to significantly reduce wake after sleep onset (WASO) and latency to persistent sleep (LPS) in patients with insomnia, with improvements observed at both 1 and 3 months for doses of 25 mg and 50 mg.

The drug has a favorable safety profile and is well tolerated across diverse patient populations, although more large-scale comparative studies are needed to determine its effectiveness relative to other dual orexin receptor antagonists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daridorexant: Comprehensive Review of A New Oral Agent for the Treatment of Insomnia. Park, J., Render PharmD, KP., Cates PharmD, DW.[2023]

Daridorexant, a treatment for insomnia, showed a significant decrease in peak concentration (Cmax) when taken with famotidine, a gastric pH modifier, indicating that higher gastric pH can affect its absorption, but the overall exposure (AUC) remained unchanged.

When co-administered with efavirenz, a moderate CYP3A4 inducer, daridorexant's Cmax and overall exposure decreased significantly, yet it was still well tolerated, suggesting that no dose adjustment is necessary when using these medications together.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of gastric pH and of a moderate CYP3A4 inducer on the pharmacokinetics of daridorexant, a dual orexin receptor antagonist. Gehin, M., Wierdak, J., Sabattini, G., et al.[2022]

Daridorexant, a dual orexin receptor antagonist, has been shown to effectively improve sleep parameters in adults with insomnia, based on phase 3 clinical studies involving various age groups, including those over 65 years old.

The medication is well tolerated with low rates of adverse events, and it does not impair next-day functioning, which is a common concern with other insomnia treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daridorexant: A New Dual Orexin Receptor Antagonist for Insomnia. Onge, ES., Phillips, B., Rowe, C.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05423717

NCT05423717 | Dose-finding Study Assessing the Efficacy, ... This study assesses the efficacy, safety, and pharmacokinetics of multiple-dose oral administration of daridorexant in pediatric subjects aged 10 to < 18 years ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11946062/

A Preliminary Report on the Effects of Daridorexant in Patients ... Results. All sleep outcomes significantly improved throughout treatment, which was generally safe and well tolerated, with mild and transient ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36484969/

Long-Term Safety and Tolerability of Daridorexant in ... Exploratory efficacy analyses suggest that improved night-time and daytime symptoms of insomnia were sustained, in particular with the highest ...

4. nature.com nature.com/articles/s41398-025-03439-8

a systematic review and network meta-analysis Therefore, any DORAs may be expected to improve overall sleep quality when administered in doses appropriate for each individual with insomnia.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2667343625000034

A patient-centric benefit-risk assessment of daridorexant for ... Both daridorexant 25 mg and 50 mg were likely to have a positive benefit-risk balance from the patient's perspective.

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2022/214985s000lbl.pdf

Quviviq - accessdata.fda.gov The safety and effectiveness of QUVIVIQ have not been established in pediatric patients. 8.5 Geriatric Use. No dose adjustment is required in patients over the ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165032724010905

Clinical safety of daridorexant in insomnia treatment Preliminary studies suggest that daridorexant might be a safe and effective treatment for insomnia, but its comprehensive safety and efficacy ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9420920/

A New Dual Orexin Receptor Antagonist for Insomnia - PMC In addition, daridorexant appears to be as safe and effective in treating insomnia in patients of all ages including those ≥65 years of age.

9. quviviqhcp.com quviviqhcp.com/safety/

Demonstrated safety studied over 12 months - Quviviq HCP Safety and efficacy of daridorexant in patients with insomnia disorder: results from two multicentre, randomised, double-blind, placebo-controlled, phase 3 ...