Daridorexant for Insomnia

No longer recruiting at 19 trial locations

Overseen By Idorsia Clinical Trials Information

Age: 18+

Sex: Any

Travel: May Be Covered

Trial Phase: Phase 4

Sponsor: Idorsia Pharmaceuticals Ltd.

Disqualifiers: Narcolepsy, Diabetes, Cancer, 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: 2

Duration: 4 weeks

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 people who have trouble sleeping and frequently wake up at night to urinate (known as nocturia). The study compares the effects of taking daridorexant with a placebo (a pill with no active medication) to assess its safety and effectiveness. Suitable participants have experienced insomnia for at least three months and have been getting up to use the bathroom at least three times a night for the past month. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits more patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team to understand any specific requirements.

What is the safety track record for daridorexant?

Research has shown that daridorexant has undergone thorough safety testing. Earlier studies found it to be well-tolerated by people with insomnia. The FDA approved daridorexant in 2022 for treating insomnia in adults, following positive results from several trials that focused on its safety and effectiveness.

These studies found that most participants did not experience serious side effects. Common mild side effects included headache and drowsiness. Overall, daridorexant has a strong safety record, making it a promising option for those seeking new treatments for insomnia. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Most treatments for insomnia, like benzodiazepines or Z-drugs, work by enhancing the effect of a neurotransmitter called GABA to induce sleep. But daridorexant works differently, targeting and blocking orexin receptors, which play a role in wakefulness. This new mechanism of action helps to promote sleep without the risk of dependency commonly associated with traditional sleep medications. Researchers are excited about daridorexant because it has the potential to improve sleep quality and duration with fewer side effects, offering a promising alternative for those struggling with insomnia.

What is the effectiveness track record for daridorexant in treating insomnia?

Research shows that daridorexant, which participants in this trial may receive, effectively treats insomnia. Approved for use in adults, it helps people fall asleep and stay asleep. Studies have found that daridorexant improves sleep quality by helping individuals fall asleep faster and reducing nighttime awakenings. It works by blocking orexin, a brain chemical that keeps people awake. Several clinical trials have demonstrated positive results, confirming its effectiveness in managing insomnia symptoms. ^{1 2 3 6 7}

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 men and women over 55 who have trouble sleeping (insomnia) and need to urinate at least three times a night (nocturia). They should be able to communicate clearly, understand the study's requirements, have an ISI© score ≥ 13, own a smartphone, and have had these sleep issues for at least three months.

Inclusion Criteria

You have a score of 13 or higher on the ISI© at Visit 1.

You have signed and dated the ICF prior to any study-mandated procedure.

I can communicate clearly and understand the study's needs.

Exclusion Criteria

Do you work the nightshift?

You drink caffeinated beverages regularly after 4 pm.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive either daridorexant or placebo once daily in the evening for 4 weeks

4 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Daridorexant
• Placebo

Trial Overview The study is testing Daridorexant's effectiveness in improving sleep among those with insomnia and frequent nighttime urination. Participants will either receive Daridorexant or a placebo (a pill without active medication), to compare outcomes between the two groups.

How Is the Trial Designed?

Group I: 50 mg daridorexant Experimental Treatment 1 Intervention

Daridorexant will be taken orally, once daily in the evening within approximately 30 min before going to bed.

Group II: Placebo Placebo Group 1 Intervention

Matching placebo will be taken orally, once daily in the evening within approximately 30 min before going to bed.

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]

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]

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, 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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022395625006090

Efficacy and Safety Profiles of FDA-Approved Dual Orexin ... A total of 19 studies were included in this review. DORAs demonstrated significant improvements in sleep onset latency, wake after sleep onset, ...

2. simcere.com simcere.com/news/detail.aspx?mtt=1511

QUVIVIQ ® - The World's New Generation Anti-Insomnia ... Results from the Phase III clinical trial in China show particularly significant improvements in sleep maintenance during the latter half of ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9553778/

Efficacy and Safety of Daridorexant in Older and Younger ... Daridorexant was approved in 2022 for the treatment of insomnia in adults following positive results in two trials that showed daridorexant ...

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

Quviviq - accessdata.fda.gov QUVIVIQ is indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance [see Clinical ...

5. en.wikipedia.org en.wikipedia.org/wiki/Daridorexant

Daridorexant Daridorexant, sold under the brand name Quviviq, is an orexin antagonist medication which is used for the treatment of insomnia.

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/20/NCT05597020/Prot_000.pdf

Daridorexant (ACT-541468) Insomnia and comorbid ... Safety and efficacy of daridorexant in patients with insomnia disorder: results from two multicentre, randomised, double-blind, placebo ...

7. simcere.com simcere.com/en/news/detail.aspx?mtt=1511

QUVIVIQ ® - The World's New Generation Anti-Insomnia ... Results from the Phase III clinical trial in China show particularly significant improvements in sleep maintenance during the latter half of ...