MedPath

Daridorexant

Generic Name
Daridorexant
Brand Names
Quviviq
Drug Type
Small Molecule
Chemical Formula
C23H23ClN6O2
CAS Number
1505484-82-1
Unique Ingredient Identifier
LMQ24G57E9

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

Published: Aug 5, 2025

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]

Continue reading the full research report

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
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
QUVIVIQ
02537443
Tablet - Oral
50 MG
7/12/2023
QUVIVIQ
02537435
Tablet - Oral
25 MG
N/A

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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