Overview
Daridorexant, formerly known as nemorexant, is a selective dual orexin receptor antagonist used to treat insomnia. Insomnia is characterized by difficulties with sleep onset and/or sleep maintenance and impairment of daytime functioning. It chronically affects the person's daily functioning and long-term health effects, as insomnia is often associated with comorbidities such as hypertension, diabetes, and depression. Conventional treatments for insomnia include drugs targeting gamma-aminobutyric acid type-A (GABA-A), serotonin, histamine, or melatonin receptors; however, undesirable side effects are frequently reported, such as next-morning residual sleepiness, motor incoordination, falls, memory and cognitive impairment. Novel drugs that target orexin receptors gained increasing attention after discovering the role of orexin signalling pathway in wakefulness and almorexant, an orexin receptor antagonist that improved sleep. Daridorexant was designed via an intensive drug discovery program to improve the potency and maximize the duration of action while minimizing next-morning residual activity. Daridorexant works on orexin receptors OX1R and OX2R to block the binding of orexins, which are wake-promoting neuropeptides and endogenous ligands to these receptors. Daridorexant reduces overactive wakefulness: in the investigational trials, daridorexant reportedly improved sleep and daytime functioning in patients with insomnia. It was approved by the FDA on January 10, 2022, under the name QUVIVIQ. as the second orexin receptor antagonist approved to treat insomnia following suvorexant. Daridorexant was approved by the European Commission on May 3, 2022, as the first dual orexin receptor antagonist approved in the market, and by Health Canada on April 26, 2023.
Indication
In the US and Europe, daridorexant is indicated for the treatment of adult patients with insomnia characterized by difficulties with sleep onset and/or sleep maintenance. The European prescribing information states that insomnia should be characterized by symptoms that are present for at least three months and have a considerable impact on daytime functioning.
Associated Conditions
- Insomnia
Research Report
Daridorexant (Quviviq®): A Comprehensive Pharmacological and Clinical Review
1.0 Introduction and Overview of Daridorexant (Quviviq®)
1.1 Executive Summary
Daridorexant is a novel, small-molecule therapeutic agent developed by Idorsia Pharmaceuticals and marketed under the brand name Quviviq®.[1] It is classified as a dual orexin receptor antagonist (DORA) and is indicated for the treatment of adult patients with chronic insomnia disorder characterized by difficulties with sleep onset and/or sleep maintenance.[3] The development of daridorexant represents a significant evolution in the pharmacological management of insomnia. Its mechanism of action, which involves the targeted antagonism of the orexin system, addresses the underlying pathophysiology of hyperarousal in insomnia, a departure from the broad central nervous system (CNS) sedation induced by traditional hypnotic agents.[5] This targeted approach, combined with a meticulously engineered pharmacokinetic profile, allows daridorexant to improve both nighttime sleep parameters and, uniquely, daytime functioning, while minimizing the residual effects that have long been a limitation of older therapies.
1.2 The Shifting Paradigm in Insomnia Treatment
Insomnia disorder is increasingly recognized not merely as a nighttime complaint but as a complex and debilitating 24-hour condition. It is defined by persistent difficulties with initiating or maintaining sleep, which leads to significant impairment of daytime functioning, including fatigue, cognitive deficits, and mood disturbances.[3] Chronic insomnia is associated with a substantial long-term health burden, including an increased risk for comorbidities such as hypertension, type 2 diabetes, and major depressive disorder.[3]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/08/22 | Not Applicable | Not yet recruiting | |||
2025/06/19 | Phase 3 | Recruiting | Nxera Pharma Korea Co., Ltd. | ||
2024/10/08 | Phase 2 | Completed | |||
2024/07/12 | N/A | Recruiting | |||
2024/05/01 | N/A | Active, not recruiting | |||
2024/03/22 | Phase 1 | Completed | |||
2024/03/15 | N/A | ENROLLING_BY_INVITATION | PeriPharm | ||
2023/08/24 | Phase 3 | Completed | |||
2023/07/17 | Phase 2 | Recruiting | Global Coalition for Adaptive Research | ||
2023/06/29 | Phase 4 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Idorsia Pharmaceuticals Ltd | 80491-7850 | ORAL | 50 mg in 1 1 | 10/31/2023 | |
Idorsia Pharmaceuticals Ltd | 80491-7825 | ORAL | 25 mg in 1 1 | 10/31/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 4/29/2022 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
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No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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No TGA approvals found for this drug. |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
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No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
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No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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No UK EMC drug information found for this drug. |
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