Safety profile of QUVIVIQ™
The safety profile of QUVIVIQ™, when taken nightly, has been demonstrated with up to 12 months of continuous treatment1,4
The safety and efficacy of QUVIVIQ™ were evaluated in two 12-week, multicentre, randomised, double-blind, parallel-group, placebo-controlled phase III studies.2
Following completion of the 12-week study period, participants were able to join a 40‑week placebo‑controlled extension study.4
View the study designs
*Including over-the-counter medication and herbal medicines.2
†A 25 mg dose is recommended for patients with moderate hepatic impairment or those using moderate CYP3A4 inhibitors (eg erythromycin, ciprofloxacin, cyclosporine).1
‡A 10 mg dose is not licensed for use, and therefore not presented.1
CYP3A4: cytochrome P450 3A4; DSM-5: Diagnostic and Statistical Manual of Mental Disorders, 5th edn
TEAEs during the 40-week extension trial of Study 1 and Study 2 4§
| Adverse event, % | QUVIVIQ™ 50 mg (n=137) | QUVIVIQ™ 25 mg (n=268) | Placebo (n=128) |
| Patients with ≥1 TEAE | 40.1 | 38.4 | 35.2 |
| Patients with ≥1 serious TEAE | 5.1 | 4.5 | 1.6 |
| TEAEs leading to discontinuation | 6.6 | 3.7 | 4.7 |
| TEAEs of special interest‖ Hallucinations Excessive daytime sleepiness Suicide/ self-injury |
0.7 0.7 0 0 |
0.4 0 0.4 0 |
0.8 0 0 0.8 |
| Nasopharyngitis | 8.0 | 4.9 | 4.7 |
| Accidental overdose | 2.9 | 1.1 | 0 |
| Somnolence | 2.9 | 0.7 | 0 |
| Fall | 2.2 | 2.2 | 1.6 |
| Headache | 2.2 | 2.2 | 1.6 |
| Cough | 2.2 | 0.7 | 0 |
| Pneumonia | 2.2 | 0.4 | 0 |
| Back pain | 1.5 | 1.9 | 0 |
| Tonsilitis | 0.7 | 0.4 | 0 |
| Upper respiratory tract infection | 0 | 2.2 | 1.6 |
| Urinary tract infection | 0 | 0.4 | 0.8 |
| Myalgia | 0 | 0.4 | 0.8 |
| Sinusitis | 0 | 0.4 | 1.6 |
| Hepatic enzyme increased | 0 | 0 | 0 |
Adapted from Kunz D et al, 20234
§In the 40-week extension trial of Studies 1 and 2, patients who completed the initial 12-week trial period underwent a 7-day single-blind placebo run-in period before continuing their original treatment for 40 weeks. Patients in the placebo arm underwent 1:1 re-randomisation to placebo or QUVIVIQ™ 25 mg.2,4
‖Identified as TEAEs of special interest after an independent safety board adjudication.4
Adverse reactions observed in Study 1 and Study 2 or in post-marketing experience1
- The majority of adverse reactions were mild to moderate in intensity
- No evidence of a dose-response relationship for the frequency or severity of adverse reactions was observed
- The adverse reaction profile in elderly participants was consistent with that in younger participants
| System organ class | Adverse reaction | Frequency¶ |
| Psychiatric disorders | Hallucination Abnormal dreams, nightmares Somnambulism |
Uncommon Uncommon Uncommon |
| Nervous system disorders | Headache Somnolence Dizziness Sleep paralysis |
Common Common Common Uncommon |
| Gastrointestinal disorders | Nausea | Common |
| General disorders and administration site conditions | Fatigue | Common |
| Immune system disorders | Hypersensitivity | Uncommon |
Adapted from QUVIVIQ™ SPC1
¶Common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100).1
Somnolence was reported in 3% and 2% of participants treated with QUVIVIQ™ 25 mg and 50 mg, respectively, compared with 2% of participants on placebo. Sleep paralysis was reported in 0.5% and 0.3% of participants receiving QUVIVIQ™ 25 mg and 50 mg, respectively, compared with no reports for placebo. Hypnagogic and hypnopompic hallucinations were reported in 0.6% of participants receiving QUVIVIQ™ 25 mg and in no participants receiving QUVIVIQ™ 50 mg or placebo.1
Upon discontinuation of QUVIVIQ™, after 12 months of continuous nightly use, there was:1,4
no evidence of physical dependence
no evidence of abuse or withdrawal symptoms
no sign of rebound insomnia
Treatment duration should be as short as possible. Treatment should be assessed within 3 months and periodically thereafter.1
This medicine is subject to additional monitoring.
Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/. Adverse events should also be reported to Idorsia at ds.safety.uk@idorsia.com.
This information is intended for UK healthcare professionals.
References
- QUVIVIQ™ (daridorexant) Summary of Product Characteristics
- Mignot E, Mayleben D et al. Safety and efficacy of daridorexant in patients with insomnia disorder: results from two multicentre, randomised, double-blind, placebo-controlled, phase 3 trials. Lancet Neurol 2022;21:125-139
- Robbins R, Quan S F et al. A nationally representative survey assessing restorative sleep in US adults. Front Sleep 2022;1:935228
- Kunz D, Dauvilliers Y et al. Long-term safety and tolerability of daridorexant in patients with insomnia disorder. CNS Drugs 2023;37(1):93-106
- Hudgens S, Phillips-Beyer A et al. Development and validation of the insomnia daytime symptoms and impacts questionnaire (IDSIQ). Patient 2021;14:249-268
- Phillips-Beyer A, Kawata A K et al. Meaningful within-patient change on the insomnia daytime symptoms and impacts questionnaire (IDSIQ): analysis of phase III clinical trial data of daridorexant. Pharmaceut Med 2023;37:291-303
- Hudgens S, Phillips-Beyer A et al. Summary of research: development and validation of the insomnia daytime symptoms and impacts questionnaire (IDSIQ). Adv Ther 2023;40:2573-2576
© NICE 2023. Daridorexant for treating long-term insomnia. Available from www.nice.org.uk/guidance/TA922. All rights reserved. Subject to Notice of rights.
NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/ publication.
UK-DA-00919 | Last updated: July 2025
QUV-Pro.idorsia QUVIVIQ Safety_June 2025
