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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

Started taking the medicine and have questions?

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.

5.0 (2)
Doctor

Svetlana Kolomeeva

Cardiology 18 years exp.

Dr. Svetlana Kolomeeva is a general practitioner and internal medicine doctor providing online consultations for adults. She helps patients manage acute symptoms, chronic conditions, and preventive care. Her clinical focus includes cardiovascular health, hypertension control, and managing symptoms like fatigue, weakness, sleep issues, and overall low energy.

Patients commonly seek her help for:

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Dr Kolomeeva combines clinical expertise with personalised care. She clearly explains diagnoses, guides patients through symptoms and treatment options, and provides actionable plans. Her consultations are designed not only to address current complaints but also to stabilise chronic conditions and prevent future complications. She supports patients through every stage of care – from first symptoms to ongoing health management.

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Марія Мартеллі

Anaesthesiology 12 years exp.

Dr Maria Martelli is a medical doctor specialising in anaesthesiology and pain medicine. She provides online consultations for adults, focusing on the assessment and management of acute, chronic, and complex pain conditions, as well as supportive care in serious illness.

She graduated from the Medical University of Silesia in Katowice and completed her specialisation in Anaesthesiology and Intensive Care. Alongside hospital work, she has extensive experience in home and inpatient hospice care, supporting patients with severe pain and advanced disease. Since 2021, she has been a certified specialist and continues to work in anaesthesiology, intensive care, and pain treatment.

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Dr Martelli takes a structured, evidence-based approach, carefully analysing symptoms, previous treatments, and overall health status. Her consultations focus on realistic pain control goals, safety of therapy, and improving daily functioning.

She is especially attentive to patients living with long-term pain or serious illness, providing clear explanations, compassionate guidance, and medically sound recommendations adapted to each individual situation.

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Дарія Портнова

Psychiatry 31 years exp.

Dr Daria Portnova is a psychiatrist and psychotherapist with over 30 years of clinical experience. She works with adults and adolescents aged 14 and over, providing online psychiatric and psychotherapeutic consultations.

In her practice, Dr Portnova supports patients facing the onset of mental health conditions, chronic psychiatric disorders, psychotic symptoms, trauma-related states, and complex emotional crises. Her work is structured and safety-focused, with an emphasis on stabilisation, accurate diagnosis, and long-term improvement in quality of life.

Patients consult Dr Daria Portnova for the following concerns:

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Dr Portnova combines psychiatric assessment with a psychotherapeutic approach. She works with evidence-based methods, including cognitive behavioural therapy (CBT) and third-wave approaches such as ACT, FACT, and CFT. Consultations are focused on clear clinical understanding, practical recommendations, and ongoing support over time.
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Sergey Ilyasov

Psychiatry 7 years exp.

Dr Sergey Ilyasov is an experienced neurologist and qualified psychiatrist who provides online consultations for adults and adolescents. Combining deep neurological expertise with a modern psychiatric approach, he ensures comprehensive diagnostics and effective treatment for a wide range of conditions affecting both physical and mental health.

Dr. Ilyasov helps patients in the following cases:

  • Chronic headaches (migraine, tension-type headache), back pain, neuropathic pain, dizziness, numbness in limbs, coordination disorders.
  • Anxiety disorders (panic attacks, generalized anxiety disorder), depression (including atypical and treatment-resistant forms), sleep disturbances (insomnia, hypersomnia, nightmares), stress, burnout.
  • Chronic pain syndromes and psychosomatic symptoms (e.g., irritable bowel syndrome related to stress, vegetative-vascular dystonia).
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  • Memory impairments, phobias, obsessive-compulsive disorder (OCD), emotional swings, and support for post-traumatic stress disorder (PTSD).

Thanks to his dual specialization in neurology and psychiatry, Dr Sergey Ilyasov offers integrated and evidence-based care for complex conditions requiring a multidisciplinary approach. His consultations focus on accurate diagnosis, development of an individualized treatment plan (including pharmacotherapy and psychotherapeutic methods), and long-term support adapted to each patient's unique needs.

Book an online consultation with Dr. Sergey Ilyasov to receive qualified assistance and improve your well-being today.

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€89
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Doctor

Taisiia Proida

Psychiatry 7 years exp.

Dr. Taisiia Proida is a psychiatrist and cognitive behavioural therapist (CBT), and a member of the European Psychiatric Association. She offers online consultations for adults aged 18 and over, combining evidence-based medicine with an individualised approach to mental health care.

She specialises in consultations and ongoing support for a wide range of mental health concerns, including:

  • Mood disorders: depression, bipolar disorder, postpartum depression.
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  • Post-traumatic stress disorder (PTSD) and complex PTSD.
  • Attention deficit hyperactivity disorder (ADHD) and autism spectrum disorder (ASD). Assessment is provided only after an initial psychiatric evaluation and during a follow-up appointment.
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  • Cyclothymia and mood fluctuations.
  • Schizophrenia spectrum and related conditions.

Dr. Proida combines clinical expertise with an empathetic approach, offering structured support based on evidence-based practices. Her work integrates CBT techniques with medical management, with a focus on anxiety and depressive disorders.

She works with clients from different countries and cultural backgrounds, adapting her communication style and recommendations to individual needs. With experience in international clinical trials (Pfizer, Merck), she values clarity, trust, and collaborative partnership in patient care.

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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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