Daridorexant for Insomnia

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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests daridorexant, a medication that helps people sleep better, on those who have trouble sleeping and frequently wake up at night to urinate. It works by calming brain activity to improve sleep. Daridorexant is a newly approved treatment for insomnia.

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 data supports the effectiveness of the drug Daridorexant for treating insomnia?

Research shows that Daridorexant helps improve sleep quality and daytime functioning in people with insomnia. In clinical trials, it was more effective than a placebo in reducing the time people stayed awake after initially falling asleep and increasing total sleep time. ^{1 2 3 4 5}

Is daridorexant safe for humans?

Daridorexant has been generally well tolerated in clinical trials for insomnia, with common side effects like fatigue, dizziness, and headache occurring at similar or slightly higher rates than placebo. Most side effects were mild, and no new safety concerns were found in a 12-month extension trial. ^{1 2 4 6 7}

How is the drug Daridorexant unique for treating insomnia?

Daridorexant is unique because it is the first dual orexin receptor antagonist approved for chronic insomnia, working by blocking the wake-promoting orexin receptors to improve sleep without affecting daytime functioning. ^{1 2 3 4 5}

Research Team

Clinical Trials

Principal Investigator

Idorsia Pharmaceuticals Ltd.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Daridorexant: First Approval. [2022]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Daridorexant in Insomnia Disorder: A Profile of Its Use. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of daridorexant in the treatment of insomnia: a systematic review and meta-analysis of randomized controlled trials. [2023]

4. New Zealand 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. [2021]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Long-Term Safety and Tolerability of Daridorexant in Patients with Insomnia Disorder. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Daridorexant: A New Dual Orexin Receptor Antagonist for Insomnia. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Daridorexant: Comprehensive Review of A New Oral Agent for the Treatment of Insomnia. [2023]