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QUVIVIQ 50 mg FILM-COATED TABLETS

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About the medicine

How to use QUVIVIQ 50 mg FILM-COATED TABLETS

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the Patient

QUVIVIQ 25 mg Film-Coated Tablets

QUVIVIQ 50 mg Film-Coated Tablets

daridorexant

This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of this leaflet includes information on how to report side effects.

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

  • Keep this leaflet, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

  1. What QUVIVIQ is and what it is used for
  2. What you need to know before you take QUVIVIQ
  3. How to take QUVIVIQ
  4. Possible side effects
  5. Storage of QUVIVIQ
  6. Contents of the pack and other information

1. What QUVIVIQ is and what it is used for

QUVIVIQ contains the active substance called daridorexant, which belongs to a class of medicines called «orexin receptor antagonists».

QUVIVIQ is used to treat insomnia in adults.

How QUVIVIQ works

Orexin is a substance produced by the brain that helps keep you awake. By blocking the action of orexin, QUVIVIQ helps you fall asleep faster, sleep longer, and improves your ability to function normally during the day.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. What you need to know before you take QUVIVIQ

Do not take QUVIVIQ

  • If you are allergic to daridorexant or any of the other ingredients of this medicine (listed in section 6).
  • If you have narcolepsy, a condition that makes you suddenly fall asleep at any time.
  • If you are taking medicines that may increase QUVIVIQ levels in the blood, such as:
  • oral medicines for treating fungal infections, such as ketoconazole, posaconazole, voriconazole, itraconazole.
  • certain medicines for treating bacterial infections, such as the antibiotics clarithromycin, josamycin, telithromycin, troleandomycin.
  • certain medicines for treating HIV infection, such as ritonavir, elvitegravir, indinavir, saquinavir, telaprevir, danoprevir, lopinavir, nelfinavir, boceprevir.
  • certain medicines for treating cancer, such as ceritinib, idelalisib, ribociclib, tucatinib.

Talk to your doctor if the medicine you are taking prevents you from taking QUVIVIQ.

Warnings and precautions

Talk to your doctor or pharmacist before starting QUVIVIQ:

  • if you have depression or have had suicidal thoughts
  • if you have a psychiatric disorder
  • if you are taking medicines that affect the brain, such as treatments for anxiety or depression
  • if you have regularly used drugs (except as medicines) or have been addicted to drugs or alcohol
  • if you have liver problems: depending on the severity, QUVIVIQ may not be recommended, or a lower dose may be required.
  • if you have breathing difficulties (such as severe chronic obstructive pulmonary disease)
  • if you have a history of falls and are over 65 years old (because the risk of falling is generally higher in patients >65 years).

Your doctor may want to monitor how the medicine affects you.

Talk to your doctor if you experience any of the following side effects while taking QUVIVIQ:

  • sleep paralysis: temporary inability to move or talk for several minutes when waking up or falling asleep
  • hallucinations: seeing or hearing vivid or disturbing things that are not real when waking up or falling asleep

If you suffer from depression and experience worsening or have thoughts of self-harm, contact your doctor immediately.

Children and adolescents

This medicine is not for children and adolescents under 18 years old because QUVIVIQ has not been tested in this age group.

Other medicines and QUVIVIQ

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, because:

  • certain antibiotics (erythromycin, ciprofloxacin, clarithromycin, rifampicin), immunosuppressants (ciclosporin), antifungals (itraconazole), cancer treatments (ceritinib), or HIV treatments (ritonavir, efavirenz) may increase or decrease the amount of QUVIVIQ in the blood. Some of these medicines may be contraindicated with QUVIVIQ (see the section “Do not take QUVIVIQ”). Your doctor will advise you.
  • certain medicines that act on the brain (e.g., diazepam, alprazolam) may interact with QUVIVIQ. Your doctor will advise you.
  • certain medicines for treating blood coagulation disorders, such as dabigatran, may interact with QUVIVIQ, requiring certain precautions. Your doctor will advise you.
  • certain medicines for treating heart failure, such as digoxin, may interact with QUVIVIQ, requiring certain precautions. Your doctor will advise you.

Taking QUVIVIQ with food, drinks, and alcohol

Taking alcohol with QUVIVIQ may increase the risk of balance and coordination disorders.

Avoid taking grapefruit or grapefruit juice at night, as it may increase the amount of QUVIVIQ in the blood.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before taking this medicine.

It is not known if QUVIVIQ can harm the fetus.

A small amount of QUVIVIQ passes into breast milk. Consult your doctor on the best way to feed your baby during treatment with QUVIVIQ.

It is not known if QUVIVIQ affects human fertility.

Driving and using machines

It is recommended that a period of approximately 9 hours elapses between taking QUVIVIQ and driving or using machines. Be careful when driving or using machines in the morning after taking QUVIVIQ. Do not engage in potentially hazardous activities if you are not sure you are fully awake, especially shortly after waking up in the first days of treatment.

QUVIVIQ contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially “sodium-free”.

3. How to take QUVIVIQ

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

How much QUVIVIQ to take

Your doctor will inform you of the dose of QUVIVIQ you should take.

The recommended dose is one 50 mg QUVIVIQ tablet per night.

If you have liver problems or are taking certain medicines, your doctor may prescribe a lower dose, one 25 mg QUVIVIQ tablet per night.

The duration of treatment should be as short as possible. After 3 months, your doctor will periodically reassess the need to continue treatment.

  • Take QUVIVIQ once a night, orally, 30 minutes before bedtime.
  • You can take QUVIVIQ with food or without food; however, if you take it with or immediately after a heavy meal, it may take longer to work.

If you take more QUVIVIQ than you should

If you have taken too much QUVIVIQ, you may experience excessive sleepiness and muscle weakness. Contact your doctor immediately.

If you forget to take QUVIVIQ

If you forget to take QUVIVIQ at bedtime, do not take it later during the night, or you may feel drowsy the next morning. Do not take a double dose to make up for forgotten tablets.

If you stop taking QUVIVIQ

Treatment with QUVIVIQ can be stopped without the need to gradually reduce the dose, and without harmful effects.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

Medicine questions

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Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur with this medicine:

Common(may affect up to 1 in 10 people):

  • headache
  • excessive sleepiness
  • dizziness
  • fatigue
  • feeling sick (nausea)

Uncommon(may affect up to 1 in 100 people):

  • temporary inability to move or talk (sleep paralysis) lasting several minutes when sleeping or waking up (see section 2).
  • seeing or hearing vivid or disturbing things that are not real (hallucinations; see section 2).
  • allergic reactions (including skin rash, hives)
  • abnormal dreams, nightmares
  • sleepwalking

If you experience any of these side effects, tell your doctor.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of QUVIVIQ

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after «EXP».

The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of QUVIVIQ

The active substance is daridorexant.

QUVIVIQ 25 mg film-coated tablets

Each tablet contains daridorexant hydrochloride, equivalent to 25 mg of daridorexant.

QUVIVIQ 50 mg film-coated tablets

Each tablet contains daridorexant hydrochloride, equivalent to 50 mg of daridorexant.

The other ingredients are:

Tablet core: mannitol (E421), microcrystalline cellulose (E460), povidone, sodium croscarmellose (see section 2 «QUVIVIQ contains sodium»), silicon dioxide, magnesium stearate

Coating: hypromellose (E464), microcrystalline cellulose (E460), glycerol, talc (E553), titanium dioxide (E171), red iron oxide (E172), black iron oxide (E172), yellow iron oxide (E172; only for 50 mg tablets).

Appearance and packaging

Film-coated tablet (tablet)

QUVIVIQ 25 mg film-coated tablets

Light purple triangular tablet with «25» engraved on one side and «i» (Idorsia logo) on the other.

QUVIVIQ 50 mg film-coated tablets

Light orange triangular tablet with «50» engraved on one side and «i» (Idorsia logo) on the other.

QUVIVIQ is available in blister packs containing 10, 20, or 30 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder

Idorsia Pharmaceuticals Deutschland GmbH

Marie-Curie-Strasse 8

79539 Lörrach

Germany

Manufacturer

Idorsia Pharmaceuticals Deutschland GmbH

Marie-Curie-Strasse 8

79539 Lörrach

Germany

PharmaKorell GmbH

Georges-Koehler-Str. 2

79539 Lörrach

Germany

Date of last revision of this leaflet 06/2023

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

Online doctors for QUVIVIQ 50 mg FILM-COATED TABLETS

Discuss questions about QUVIVIQ 50 mg FILM-COATED TABLETS, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Doctor

Tarek Agami

General medicine 11 years exp.

Dr. Tarek Agami is a general practitioner registered in both Portugal and Israel, with broad experience in family and preventive medicine. He offers online consultations for adults and children, providing personalised support for primary care needs, chronic disease management, and everyday health concerns.

Dr. Agami received clinical training and worked in leading medical institutions in Israel (Kaplan Medical Center, Barzilai Medical Center, Wolfson Medical Center) and Portugal (European Healthcare City, Viscura Internacional, Hospital Dr. José Maria Grande, Hospital Vila Franca de Xira). His approach combines international medical standards with individualised attention to each patient.

Main areas of consultation:

  • Diagnosis and treatment of acute and chronic conditions (high blood pressure, diabetes, respiratory infections, cardiovascular symptoms)
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  • Treatment adjustments and lifestyle recommendations based on your personal history
Dr. Agami provides medical support for patients using GLP-1 medications (such as Ozempic or Mounjaro) as part of a weight loss strategy. He offers individualised treatment planning, regular follow-up, dose adjustment, and advice on combining medication with sustainable lifestyle changes. Consultations follow the medical standards accepted in Portugal and Israel.

Dr. Agami is committed to evidence-based, patient-centred care, ensuring that each person receives trusted medical support tailored to their health goals.

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Nuno Tavares Lopes

Family medicine 18 years exp.

Dr. Nuno Tavares Lopes is a licensed physician in Portugal with 17 years of experience in emergency medicine, family and general practice, and public health. He is the Director of Medical and Public Health Services at an international healthcare network and serves as an external consultant for the WHO and ECDC.

  • Emergency care: infections, fever, chest/abdominal pain, minor injuries, paediatric emergencies
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  • Sick leave (Baixa médica) connected to Segurança Social in Portugal
  • IMT medical certificates for driving licence exchange
Dr. Nuno Tavares Lopes provides medical support for patients using GLP-1 medications (Mounjaro, Wegovy, Ozempic, Rybelsus) as part of a weight loss strategy. He offers individualised treatment planning, regular follow-up, dose adjustment, and advice on combining medication with sustainable lifestyle changes. Consultations follow the medical standards accepted in Europe.

Dr. Lopes also provides interpretation of medical tests, follow-up care for complex patients, and multilingual support. Whether for urgent concerns or long-term care, he helps patients act with clarity and confidence.

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Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques.

For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance.

Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults.

In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions.

Patients commonly seek his care for:

  • seasonal and perennial allergies
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  • urticaria, atopic dermatitis and skin reactions
  • recurrent infections in children
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  • general family medicine concerns
Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.
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Anastasiia Hladkykh

Psychiatry 15 years exp.

Dr Anastasiia Hladkykh is a physician-psychotherapist and psychologist with over 14 years of experience working with individuals struggling with various types of addictions and their families. She provides online consultations for adults, combining medical knowledge with deep psychological support and practical tools.

Key areas of expertise:

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Therapeutic approach:
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  • Certified in multiple evidence-based methods: CBT, NLP (Master Practitioner), Ericksonian hypnosis, symbol drama, art therapy, and systemic therapy.
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Experience and background:
  • Member of the German association Gesundheitpraktikerin and the NGO “Mit dem Sonne in jedem Herzen.”
  • More than 18 publications in international peer-reviewed journals, translated into several languages.
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€130

Frequently Asked Questions

Is a prescription required for QUVIVIQ 50 mg FILM-COATED TABLETS?
QUVIVIQ 50 mg FILM-COATED TABLETS requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in QUVIVIQ 50 mg FILM-COATED TABLETS?
The active ingredient in QUVIVIQ 50 mg FILM-COATED TABLETS is daridorexant. This information helps identify medicines with the same composition but different brand names.
Who manufactures QUVIVIQ 50 mg FILM-COATED TABLETS?
QUVIVIQ 50 mg FILM-COATED TABLETS is manufactured by Idorsia Pharmaceuticals Deutschland Gmbh. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of QUVIVIQ 50 mg FILM-COATED TABLETS online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether QUVIVIQ 50 mg FILM-COATED TABLETS is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to QUVIVIQ 50 mg FILM-COATED TABLETS?
Other medicines with the same active substance (daridorexant) include QUVIVIQ 25 mg FILM-COATED TABLETS, BUCCOLAM 10 mg ORAL SOLUTION, BUCCOLAM 2.5 mg ORAL SOLUTION. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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