What side effects are associated with this type of intervention?

Common treatments for insomnia, such as eszopiclone, zolpidem, and lemborexant, have varying side effect profiles. Eszopiclone may cause substantial adverse events, while zolpidem is associated with a higher number of dropouts due to side effects like dizziness and visual disturbances. Lemborexant has a favorable profile, but long-term safety data are inconclusive. Daridorexant, another Dual Orexin Receptor Antagonist, is effective but may have poor tolerability, with side effects including potential changes in alertness and sleepiness. Overall, these medications can be effective but require careful consideration of their side effects.

What prior FDA approvals exist?

Daridorexant is a Dual Orexin Receptor Antagonist (DORA) used for the treatment of insomnia. Other FDA-approved drugs in this class include Suvorexant and Lemborexant. Suvorexant was the first DORA approved by the FDA, followed by Lemborexant. These medications work by blocking the action of orexin, a neurotransmitter involved in wakefulness, thereby promoting sleep. In addition to DORAs, other classes of drugs approved for insomnia include benzodiazepine receptor agonists (e.g., Eszopiclone, Zolpidem) and melatonin receptor agonists (e.g., Ramelteon).

What other types of research exist?

Promising novel alternatives to Daridorexant for insomnia patients in 2024 include: 1) TAK-925, an orexin 2 receptor agonist, which has shown potential in early-phase trials for improving sleep regulation. 2) Suvorexant, another dual orexin receptor antagonist, which has been effective in treating insomnia and may offer a different profile of benefits. 3) Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered via telehealth, which is gaining traction as a non-pharmacological approach with long-term benefits.

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Orexin Antagonist

Daridorexant for Insomnia

Verified Trial

Phase 4

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

Be older than 18 years old

Timeline

Screening 21 days

Treatment 3 months

Follow Up 10 days

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects of Daridorexant are not listed here, common ones may include drowsiness during the day, headache, dizziness or lightheadedness. Side effects can vary from person to person.

Timeline

Screening ~ 21 days1 visit

Treatment ~ 3 months5 visits

Follow Up ~ 10 days2 visits

Screening ~ 21 days

Treatment ~ 3 months

Follow Up ~10 days

This trial's timeline: 21 days for screening, 3 months for treatment, and 10 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 Week 4 in subjective total sleep time (sTST)

Side effects data

From 2020 Phase 3 trial • 924 Patients • NCT03575104

12%

Nasopharyngitis

Headache

100%

80%

60%

40%

20%

Study treatment Arm

Daridorexant 10 mg

Daridorexant 25 mg

Placebo

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: 50 mg daridorexantExperimental Treatment1 Intervention

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

Group II: PlaceboPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Daridorexant

2020

Completed Phase 3

~1300

Do I qualify?Apply below to find out

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

The most common treatments for insomnia include benzodiazepines, non-benzodiazepine hypnotics (e.g., zolpidem), melatonin receptor agonists (e.g., ramelteon), and Dual Orexin Receptor Antagonists (DORAs) like daridorexant. Benzodiazepines and non-benzodiazepine hypnotics enhance the effect of the neurotransmitter GABA, promoting sedation. Melatonin receptor agonists mimic the sleep-regulating hormone melatonin, aiding in sleep onset. DORAs, such as daridorexant, work by blocking orexin receptors, which play a role in wakefulness, thereby promoting sleep. Understanding these mechanisms helps patients and doctors choose the most appropriate treatment based on the specific sleep issues and potential side effects, leading to better management of insomnia.