What is the mechanism of action of this treatment?

Dual Orexin Receptor Antagonists (DORAs), such as daridorexant, work by blocking the action of orexins, neuropeptides that promote wakefulness, thereby facilitating sleep onset and maintenance. Melatonin and its agonists, like ramelteon, mimic the natural hormone melatonin to regulate the sleep-wake cycle, making them particularly useful for sleep-onset insomnia. Other common treatments include benzodiazepine receptor agonists and atypical antidepressants, which enhance the effect of GABA or modulate serotonin, respectively, to promote sedation. Understanding these mechanisms is crucial for insomnia patients as it helps tailor treatments to their specific sleep issues, improving efficacy and minimizing side effects.

What side effects are associated with this type of intervention?

The most common treatments for insomnia include Dual Orexin Receptor Antagonists (DORAs) like Daridorexant and lemborexant, as well as benzodiazepine receptor agonists (BZRAs) like eszopiclone and zolpidem. DORAs such as lemborexant generally have a favorable profile, but long-term safety data are inconclusive. BZRAs like eszopiclone and zolpidem are effective but can cause significant adverse effects, including dependency, cognitive impairment, and next-day drowsiness. Zolpidem, in particular, has a higher rate of dropouts due to side effects compared to placebo. Overall, while these medications can be effective, their side effects and long-term safety profiles must be carefully considered.

What prior FDA approvals exist?

Daridorexant is a Dual Orexin Receptor Antagonist (DORA), a class of drugs that includes other FDA-approved medications such as Suvorexant and Lemborexant. These medications work by blocking the action of orexin, a neurotransmitter involved in wakefulness, thereby promoting sleep. Suvorexant (Belsomra) was the first DORA approved by the FDA in 2014, followed by Lemborexant (Dayvigo) in 2019. Both drugs have shown efficacy in improving sleep onset and maintenance in patients with insomnia.

What other types of research exist?

Promising novel alternatives to Daridorexant for insomnia patients in 2024 include Suvorexant, another dual orexin receptor antagonist, and Lemborexant, which has shown efficacy in treating insomnia. Additionally, novel orexin receptor agonists like TAK-925 are being explored for their potential benefits in sleep disorders.

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Orexin Antagonist

Daridorexant for Pediatric Insomnia

Phase 2

Recruiting

Research Sponsored by Idorsia Pharmaceuticals Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female subjects aged ≥ 10 and < 18 years at the time of signing the ICF

Be younger than 18 years old

Must not have

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

Any other diagnosed sleep-wake disorder as defined in DSM-5 or ICSD-3 (e.g., restless legs syndrome, circadian rhythm sleep wake disorder, parasomnias, narcolepsy) at Screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up psg will be performed on 2 nights during the screening period and on day 1 of the treatment period (total duration: 3 days).

Summary

This trial tests the safety and effectiveness of a sleep medicine called daridorexant in children and teenagers who have trouble sleeping. The medicine helps them sleep better by blocking signals in the brain that keep them awake. Daridorexant has been studied in adults for its effectiveness in improving sleep onset and maintenance.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, common ones associated with sleep medications may include dizziness, headache, nausea, daytime drowsiness or fatigue. Any potential side effects will be closely monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 10 and 17 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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My body weight is less than 25 kg.

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I have been napping for over an hour on most weekdays for the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ psg will be performed on 2 nights during the screening period and on day 1 of the treatment period (total duration: 3 days).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~psg will be performed on 2 nights during the screening period and on day 1 of the treatment period (total duration: 3 days).

This trial's timeline: 3 weeks for screening, Varies for treatment, and psg will be performed on 2 nights during the screening period and on day 1 of the treatment period (total duration: 3 days). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline to Day 1 in Total Sleep Time (TST) as measured by polysomnography (PSG).

Side effects data

From 2020 Phase 3 trial • 930 Patients • NCT03545191

Nasopharyngitis

Headache

100%

80%

60%

40%

20%

Study treatment Arm

Daridorexant 25 mg

Daridorexant 50 mg

Placebo

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Daridorexant 50 mgExperimental Treatment1 Intervention

Group II: Daridorexant 25 mgExperimental Treatment1 Intervention

Group III: Daridorexant 10 mgExperimental Treatment1 Intervention

Group IV: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Daridorexant 10 mg

2023

Completed Phase 3

~850

Daridorexant 25 mg

2023

Completed Phase 3

~1810

Daridorexant 50 mg

2018

Completed Phase 3

~1770

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Dual Orexin Receptor Antagonists (DORAs), such as daridorexant, work by blocking the action of orexins, neuropeptides that promote wakefulness, thereby facilitating sleep onset and maintenance. Melatonin and its agonists, like ramelteon, mimic the natural hormone melatonin to regulate the sleep-wake cycle, making them particularly useful for sleep-onset insomnia. Other common treatments include benzodiazepine receptor agonists and atypical antidepressants, which enhance the effect of GABA or modulate serotonin, respectively, to promote sedation. Understanding these mechanisms is crucial for insomnia patients as it helps tailor treatments to their specific sleep issues, improving efficacy and minimizing side effects.