Daridorexant: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: March 12, 2026🚩 Report this page

Daridorexant

Orexin Receptor Antagonists

Sold as QUVIVIQ

GB MHRACA Health CanadaEU EMA

Drug class: Orexin Receptor Antagonists
Availability: See label
Routes: Oral
Markets covered: 3
Products on record: 5

Overview

Daridorexant is an active pharmaceutical ingredient in the Orexin Receptor Antagonists group (N05CJ). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	2	October 17, 2025
CA Canada	Health Canada	2	March 22, 2025
EU European Union	EMA	1	March 12, 2026

GBUnited Kingdom· MHRA

2 products

Uses

GBOfficial regulatory label· revised October 17, 2025[1]

QUVIVIQ is indicated for the treatment of adult patients with insomnia characterised by symptoms present for at least 3 months and considerable impact on daytime functioning.

How to take

CACanada· Health Canada

2 products

Uses

CAOfficial regulatory label· revised March 22, 2025[2]

QUVIVIQ (daridorexant) is indicated for the management of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. 1 Pediatrics Pediatrics (< 18 years of age): The safety and efficacy of QUVIVIQ in pediatric patients have not been established; therefore, Health Canada has not authorized an indication for pediatric use.
2 Geriatrics Geriatrics (≥ 65 years of age): No dose adjustment is required in patients over the age of 65 years.

How to take

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised March 12, 2026[3]

QUVIVIQ is indicated for the treatment of adult patients with insomnia characterised by symptoms present for at least 3 months and considerable impact on daytime functioning.

How to take

Sources & citations

[1]MHRA (UK) · PLGB487110003 · revised October 17, 2025
[2]Health Canada (DPD) · 02537435 · revised March 22, 2025
[3]European Medicines Agency · EMEA/H/C/005634 · revised March 12, 2026

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised October 17, 2025[1]

Summary of safety profile The most frequently reported adverse reactions were headache and somnolence. The majority of adverse reactions were mild to moderate in intensity. No evidence of a dose-relationship for the frequency or severity of adverse reactions was observed.
The adverse reaction profile in elderly subjects was consistent with younger subjects. Tabulated list of adverse reactions Table 1 shows adverse reactions that occurred in Study 1 and Study 2 or in post- marketing experience. The frequency of adverse reactions is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. The safety of daridorexant was evaluated in three placebo-controlled Phase 3 clinical studies. A total of 1847 subjects (including approximately 40% elderly subjects [≥ 65 years old]) received daridorexant 50 mg (N = 308); 25 mg (N = 618); or 10 mg (N = 306), or placebo (N = 615).
A total of 576 subjects were treated with daridorexant for at least 6 months and 331 for at least 12 months.
Table 1:
Adverse reactions System organ class Adverse reaction Frequency Immune system disorders Hypersensitivity (including rash, urticaria) Uncommon Hallucination Uncommon Abnormal dreams, nightmares Uncommon Psychiatric disorders Somnambulism Uncommon Headache Common Somnolence Common Dizziness Common Nervous system disorders Sleep paralysis Uncommon Gastrointestinal disorders Nausea Common General disorders and administration site conditions Fatigue Common Description of selected adverse reactions Somnolence Somnolence was reported in 3% and 2% of subjects treated with daridorexant 25 mg and 50 mg, respectively, compared to 2% of subjects on placebo.
3% subjects receiving daridorexant 25 mg and 50 mg, respectively, compared to no reports for placebo. 6% subjects receiving daridorexant 25 mg compared to no cases with daridorexant 50 mg or placebo. Sleep paralysis and hallucinations occur mainly during the first weeks of treatment.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

GBOfficial regulatory label· Warnings and precautions· revised October 17, 2025[1]

Elderly Because of the general risk of falls in the elderly, daridorexant should be used with caution in this population, although clinical studies did not show an increase in the incidence of falls on daridorexant compared to placebo.
QUVIVIQ should be administered with caution in patients older than 75 years since efficacy and safety data in this population are limited. 7). Caution should be exercised when prescribing QUVIVIQ concomitantly with CNS- depressant medicinal products due to potentially additive effects, and a dose adjustment of either QUVIVIQ or the concomitant CNS depressants should be considered.
5). 8). Symptoms similar to mild cataplexy have been reported with dual orexin receptor antagonists. Prescribers should explain the nature of these events to patients when prescribing QUVIVIQ. Should such events occur, patients need to be further evaluated and, depending on the nature and severity of the events, discontinuation of treatment should be considered.
Worsening of depression and suicidal ideation In primarily depressed patients treated with hypnotics, worsening of depression and suicidal thoughts and actions have been reported. As with other hypnotics, QUVIVIQ should be administered with caution in patients exhibiting symptoms of depression.
Isolated cases of suicidal ideation have been reported in Phase 3 clinical studies, in subjects with pre-existing psychiatric conditions and/or stressful living conditions, across all treatment groups, including placebo. Suicidal tendencies may be present in patients with depression and protective measures may be required.
Patients with psychiatric co-morbidities QUVIVIQ should be administered with caution in patients with psychiatric co- morbidities since efficacy and safety data in this patient population are limited. Patients with compromised respiratory function Daridorexant did not increase the frequency of apnoea/hypopnoea events or cause oxygen desaturation in patients with mild to moderate (5 to < 30 events per hour of sleep) or severe (≥ 30 events per hour of sleep) obstructive sleep apnoea (OSA).
Nor did it cause oxygen desaturation in patients with moderate chronic obstructive pulmonary disease (COPD). Daridorexant has not been studied in patients with severe COPD (FEV1 < 40% of predicted). Caution should be exercised when prescribing QUVIVIQ to patients with severe COPD.

This is not medical advice. Consult a qualified healthcare professional.

CAOfficial regulatory label· revised March 22, 2025[2]

1 Dosing Considerations Food Effect: QUVIVIQ can be taken with or without food, however, sleep onset may be delayed if taken with or soon after a high-fat and high-calorie meal. 5 Drug-Food Interactions.
Co-administration with CYP3A4 inhibitors:
The recommended dose of QUVIVIQ is 25 mg when used with moderate CYP3A4 inhibitors. Concomitant use of QUVIVIQ with strong inhibitors of CYP3A4 is contraindicated. 4 Drug-Drug Interactions, Effect of other compounds on the PK of daridorexant.
Co-administration with CNS-depressants:
In the case of co-administration of QUVIVIQ with CNS- depressant drugs, dose adjustments of QUVIVIQ and/or the other drug(s) may be required, based on clinical evaluation, due to potentially additive effects. 2 Drug Interactions Overview, CNS-active agents.
2 Recommended Dose and Dosage Adjustment The recommended dose of QUVIVIQ for adults is one tablet of 50 mg once per night, taken orally in the evening within 30 minutes before going to bed, with at least 7 hours remaining prior to planned awakening.
QUVIVIQ® (daridorexant) Page 5 of 29 Some patients may be treated with 25 mg once per night. See 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic and 9 DRUG INTERACTIONS.
Pediatrics (< 18 years of age):
The safety and efficacy of QUVIVIQ in pediatric patients have not been established. Therefore, Health Canada has not authorized an indication for pediatric use.
Geriatrics (≥ 65 years of age):
No dose adjustment is required in patients over the age of 65 years.
Patients with hepatic impairment:
No dose adjustment is required in patients with mild hepatic impairment. The recommended dose of QUVIVIQ is 25 mg in patients with moderate hepatic impairment. QUVIVIQ has not been studied and is not recommended in patients with severe hepatic impairment.
3 Pharmacokinetics, Special Populations and Conditions, Hepatic Impairment.
Patients with renal impairment:
No dose adjustment is required in patients with renal impairment (including severe). 3 Pharmacokinetics, Special Populations and Conditions, Renal Impairment. 5 Missed Dose QUVIVIQ should be taken within 30 minutes before going to bed.
If a patient forgets to take QUVIVIQ, they should not take it later during the night, otherwise they may feel drowsy in the morning.

This is not medical advice. Consult a qualified healthcare professional.

Side effects & warnings

CAOfficial regulatory label· Adverse reactions· revised March 22, 2025[2]

1 Adverse Reaction Overview The most frequently reported adverse reaction during the double-blind treatment period in Phase 3 clinical trials with QUVIVIQ (reported in at least 2% of patients and with a ≥ 1% difference vs placebo) was headache.
The majority of adverse reactions were mild to moderate in intensity. No evidence of a dose-relationship for the frequency or severity of adverse reactions was observed. The adverse reaction profile in elderly patients was consistent with younger patients.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials, therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. The safety of QUVIVIQ was evaluated in three placebo-controlled Phase 3 clinical studies (two 3-month confirmatory studies of identical design [Study 1 and Study 2], and a 9-month extension study [Study 3]).
Study 1 included the 50 and 25 mg doses of QUVIVIQ, while Study 2 included 25 and 10 mg QUVIVIQ. A total of 1847 patients (including approximately 39% elderly patients [≥ 65 years old]), received QUVIVIQ 50 mg (N = 308); 25 mg (N = 618); or 10 mg (N = 306) or placebo (N = 615).
A total of 576 patients were treated with QUVIVIQ for at least 6 months and 331 for at least 12 months. Table 2 shows adverse reactions that occurred in at least 2% of patients treated with QUVIVIQ and more frequently (≥ 1%) than in patients who received placebo in Study 1 and Study 2.
Table 2 – Adverse reactions reported with a frequency of ≥ 2% in QUVIVIQ-treated patients and greater (≥ 1%) than in placebo-treated patients in 3-month efficacy trials (Study 1 and Study 2) System organ class QUVIVIQ 25 mg* N = 618 (%) QUVIVIQ 50 mg* N = 308 (%) Placebo* N = 615 (%) Nervous system disorders Headache 5 6 4 Somnolence 3 2 2 Dizziness 2 2 1 General disorders and administration site conditions Fatigue 3 2 1 Gastrointestinal disorders Nausea 1 2 1 * 50 mg incidence rates are from Study 1, 25 mg rates from pooled data.
Placebo rates were the same in Study 1 and in the pooled data. QUVIVIQ® (daridorexant) Page 12 of 29 Unclassified / Non classifié The adverse reactions reported during long-term treatment up to 1 year were consistent with those observed during the first 3 months of treatment.
3% of patients receiving daridorexant 25 mg and 50 mg, respectively, compared to no reports for placebo. 6% of patients receiving daridorexant 25 mg compared to no cases with daridorexant 50 mg or placebo. See 7 WARNINGS AND PRECAUTIONS, General, Sleep paralysis, hallucinations, and cataplexy-like symptoms.
5 Post-Market Adverse Reactions Immune system disorders: Hypersensitivity (such as angioedema, rash, urticaria) Psychiatric disorders: Abnormal dreams or nightmares, complex sleep behaviours (see 7 WARNINGS AND PRECAUTIONS, General, Complex Sleep Behaviours)

CAOfficial regulatory label· Warnings and precautions· revised March 22, 2025[2]

2 Breast-feeding 11/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................
4 1 INDICATIONS ............................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................
4 4 DOSAGE AND ADMINISTRATION ................................................................................. 5 5 OVERDOSAGE..............................................................................................................
5 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 6 7 WARNINGS AND PRECAUTIONS .................................................................................. 10 8 ADVERSE REACTIONS ................................................................................................
12 9 DRUG INTERACTIONS ................................................................................................ 15 10 CLINICAL PHARMACOLOGY .......................................................................................
16 11 STORAGE, STABILITY, AND DISPOSAL ........................................................................ 17 PART II: SCIENTIFIC INFORMATION .......................................................................................
17 13 PHARMACEUTICAL INFORMATION ............................................................................ 17 14 CLINICAL TRIALS ........................................................................................................
19 16 NON-CLINICAL TOXICOLOGY ..................................................................................... 23 PATIENT MEDICATION INFORMATION ..................................................................................

This is not medical advice. Consult a qualified healthcare professional.

Side effects & warnings

EUOfficial regulatory label· Adverse reactions· revised March 12, 2026[3]

Summary of safety profile The most frequently reported adverse reactions were headache and somnolence. 8 The majority of adverse reactions were mild to moderate in intensity. No evidence of a dose- relationship for the frequency or severity of adverse reactions was observed.
The adverse reaction profile in elderly subjects was consistent with younger subjects. Tabulated list of adverse reactions Table 1 shows adverse reactions that occurred in Study 1 and Study 2 or in post-marketing experience. The frequency of adverse reactions is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. The safety of daridorexant was evaluated in three placebo-controlled Phase 3 clinical studies. A total of 1847 subjects (including approximately 40% elderly subjects [≥ 65 years old]) received daridorexant 50 mg (N = 308); 25 mg (N = 618); or 10 mg (N = 306), or placebo (N = 615).
A total of 576 subjects were treated with daridorexant for at least 6 months and 331 for at least 12 months.
Table 1:
Adverse reactions System organ class Adverse reaction Frequency Immune system disorders Hypersensitivity (including rash, urticaria) Uncommon Psychiatric disorders Hallucination Uncommon Abnormal dreams, nightmares Uncommon Somnambulism Uncommon Nervous system disorders Headache Common Somnolence Common Dizziness Common Sleep paralysis Uncommon Gastrointestinal disorders Nausea Common General disorders and administration site conditions Fatigue Common Description of selected adverse reactions Somnolence Somnolence was reported in 3% and 2% of subjects treated with daridorexant 25 mg and 50 mg, respectively, compared to 2% of subjects on placebo.
3% subjects receiving daridorexant 25 mg and 50 mg, respectively, compared to no reports for placebo. 6% subjects receiving daridorexant 25 mg compared to no cases with daridorexant 50 mg or placebo. Sleep paralysis and hallucinations occur mainly during the first weeks of treatment.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
9

EUOfficial regulatory label· Warnings and precautions· revised March 12, 2026[3]

Elderly Because of the general risk of falls in the elderly, daridorexant should be used with caution in this population, although clinical studies did not show an increase in the incidence of falls on daridorexant compared to placebo.
QUVIVIQ should be administered with caution in patients older than 75 years since efficacy and safety data in this population are limited. 7). Caution should be exercised when prescribing QUVIVIQ concomitantly with CNS-depressant medicinal products due to potentially additive effects, and a dose adjustment of either QUVIVIQ or the concomitant CNS depressants should be considered.
5). 8). Symptoms similar to mild cataplexy have been reported with dual orexin receptor antagonists. Prescribers should explain the nature of these events to patients when prescribing QUVIVIQ. Should such events occur, patients need to be further evaluated and, depending on the nature and severity of the events, discontinuation of treatment should be considered.
Worsening of depression and suicidal ideation In primarily depressed patients treated with hypnotics, worsening of depression and suicidal thoughts and actions have been reported. As with other hypnotics, QUVIVIQ should be administered with caution in patients exhibiting symptoms of depression.
Isolated cases of suicidal ideation have been reported in Phase 3 clinical studies, in subjects with pre- existing psychiatric conditions and/or stressful living conditions, across all treatment groups, including placebo. Suicidal tendencies may be present in patients with depression and protective measures may be required.
Patients with psychiatric co-morbidities QUVIVIQ should be administered with caution in patients with psychiatric co-morbidities since efficacy and safety data in this patient population are limited. Patients with compromised respiratory function Daridorexant did not increase the frequency of apnoea/hypopnoea events or cause oxygen desaturation in patients with mild to moderate (5 to < 30 events per hour of sleep) or severe (≥ 30 events per hour 5 of sleep) obstructive sleep apnoea (OSA).
Nor did it cause oxygen desaturation in patients with moderate chronic obstructive pulmonary disease (COPD). Daridorexant has not been studied in patients with severe COPD (FEV1 < 40% of predicted). Caution should be exercised when prescribing QUVIVIQ to patients with severe COPD.

This is not medical advice. Consult a qualified healthcare professional.

Overview

Regulatory status by market

GBUnited Kingdom· MHRA

CACanada· Health Canada

EUEuropean Union· EMA

Drugs in the same class

Sources & citations