Quviviq 50mg Tablets
It is used to treat sleep problems.
Drug Class
Hypnotic
Pharmacologic Class
Dual Orexin Receptor Antagonist (DORA)
Pregnancy Category
Not available
FDA Approved
Jan 2022
DEA Schedule
Not Controlled
Overview
What is this medicine?
Quviviq is a medication used to help adults who have trouble falling asleep or staying asleep. It works by blocking certain chemicals in your brain that keep you awake, helping you to fall asleep more easily and stay asleep through the night.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication effectively, follow your doctor's instructions and read all accompanying information carefully. Take the medication within 30 minutes of bedtime, with or without food. Note that taking it with or immediately after a meal may delay its onset of action. If you continue to experience sleep difficulties after 7 to 10 days, consult your doctor.
It is crucial to take this medication only when you can devote a full night's sleep, lasting at least 7 to 8 hours, before resuming activities. This ensures your safety and the medication's effectiveness.
Storing and Disposing of Your Medication
Store the medication at room temperature in a dry location, avoiding bathrooms. Keep it in a secure, inaccessible place, such as a locked box or area, to prevent accidental ingestion by children, other individuals, or pets. Dispose of unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. For guidance on disposal, consult your pharmacist, who may be aware of local drug take-back programs.
Missing a Dose
If you miss a dose, take it as soon as possible. However, if taking the missed dose would result in less than 7 hours of sleep before your next activity, skip the dose and resume your regular schedule. Do not take more than one dose of this medication in a 24-hour period.
To use this medication effectively, follow your doctor's instructions and read all accompanying information carefully. Take the medication within 30 minutes of bedtime, with or without food. Note that taking it with or immediately after a meal may delay its onset of action. If you continue to experience sleep difficulties after 7 to 10 days, consult your doctor.
It is crucial to take this medication only when you can devote a full night's sleep, lasting at least 7 to 8 hours, before resuming activities. This ensures your safety and the medication's effectiveness.
Storing and Disposing of Your Medication
Store the medication at room temperature in a dry location, avoiding bathrooms. Keep it in a secure, inaccessible place, such as a locked box or area, to prevent accidental ingestion by children, other individuals, or pets. Dispose of unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. For guidance on disposal, consult your pharmacist, who may be aware of local drug take-back programs.
Missing a Dose
If you miss a dose, take it as soon as possible. However, if taking the missed dose would result in less than 7 hours of sleep before your next activity, skip the dose and resume your regular schedule. Do not take more than one dose of this medication in a 24-hour period.
Lifestyle & Tips
- Take Quviviq within 30 minutes of going to bed, and only if you have at least 7 hours available for sleep.
- Avoid taking Quviviq with or immediately after a heavy meal, as this may delay its effects.
- Practice good sleep hygiene: maintain a consistent sleep schedule, create a comfortable sleep environment, avoid caffeine and alcohol before bed, and limit screen time before sleep.
- Do not take more than the prescribed dose.
- Do not take Quviviq if you have narcolepsy.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
50 mg orally once nightly, within 30 minutes of going to bed, with at least 7 hours remaining before planned awakening.
Dose Range:
25 - 50 mg
Condition-Specific Dosing:
concomitant moderate CYP3A4 inhibitors:
25 mg once nightly
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment needed
Moderate:
No dose adjustment needed
Severe:
No dose adjustment needed
Dialysis:
Not studied in patients with end-stage renal disease (ESRD) on dialysis; use with caution.
Hepatic Impairment:
Mild:
No dose adjustment needed (Child-Pugh A)
Moderate:
Maximum dose 25 mg once nightly (Child-Pugh B)
Severe:
Not recommended (Child-Pugh C)
Pharmacology
Mechanism of Action
Daridorexant is a dual orexin receptor antagonist (DORA) that blocks the binding of wake-promoting neuropeptides orexin A and orexin B to orexin receptors OX1R and OX2R. By blocking the activation of orexin receptors, daridorexant suppresses wakefulness, thereby promoting sleep.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 62%
Tmax:
1 to 2 hours
FoodEffect:
High-fat meal delays Tmax by approximately 1.3 hours and decreases Cmax by 23%. Take without food or at least 2 hours after a meal for faster onset.
Distribution:
Vd:
Approximately 83 L
ProteinBinding:
Approximately 90%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 8 hours
Clearance:
Not available
ExcretionRoute:
Feces (approximately 57%), Urine (approximately 28%)
Unchanged:
<1% (in urine)
Pharmacodynamics
OnsetOfAction:
Within 30 minutes (time to sleep onset)
PeakEffect:
Not directly applicable as a sleep aid, but related to Cmax for sleep-promoting effects.
DurationOfAction:
Approximately 8 hours (sufficient for a full night's sleep)
Confidence:
High
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
New or worsening behavioral or mood changes, including depression or suicidal thoughts
Hallucinations (seeing or hearing things that are not there) when falling asleep or waking up
Temporary inability to move or speak, lasting up to several minutes, when falling asleep or waking up
Muscle weakness, which can occur at any time of day and last from seconds to several minutes
If you experience muscle weakness, contact your doctor immediately.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience:
Daytime sleepiness
Headache
Feeling tired or weak
These are not all the possible side effects of this medication. If you have questions or concerns about side effects, consult your doctor.
Reporting Side Effects
To report side effects, you can:
Call your doctor for medical advice
Contact the FDA at 1-800-332-1088
* Visit the FDA's MedWatch website at https://www.fda.gov/medwatch
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
New or worsening behavioral or mood changes, including depression or suicidal thoughts
Hallucinations (seeing or hearing things that are not there) when falling asleep or waking up
Temporary inability to move or speak, lasting up to several minutes, when falling asleep or waking up
Muscle weakness, which can occur at any time of day and last from seconds to several minutes
If you experience muscle weakness, contact your doctor immediately.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience:
Daytime sleepiness
Headache
Feeling tired or weak
These are not all the possible side effects of this medication. If you have questions or concerns about side effects, consult your doctor.
Reporting Side Effects
To report side effects, you can:
Call your doctor for medical advice
Contact the FDA at 1-800-332-1088
* Visit the FDA's MedWatch website at https://www.fda.gov/medwatch
Seek Immediate Medical Attention If You Experience:
- Excessive daytime sleepiness or dizziness the next day
- Unusual sleep behaviors such as sleep-driving, sleep-eating, or making phone calls while not fully awake (stop taking the medication and contact your doctor immediately if these occur)
- Worsening depression or new thoughts of harming yourself
- Temporary inability to move or speak (sleep paralysis) or vivid, disturbing dreams/hallucinations upon falling asleep or waking up
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as narcolepsy (falling asleep unexpectedly) or liver problems.
If you are taking any sleep aids, including prescription or over-the-counter (OTC) medications, natural products, or supplements. If you are unsure about specific products, consult your doctor or pharmacist.
Any medications, including prescription and OTC drugs, natural products, or vitamins, that you are currently taking. This is crucial because some medications, such as those used to treat HIV, infections, seizures, and other conditions, may interact with this medication.
* Note that this is not an exhaustive list of all potential interactions. Therefore, it is vital to discuss all your medications and health conditions with your doctor.
To ensure your safety, inform your doctor and pharmacist about all your medications, including prescription and OTC drugs, natural products, and vitamins, as well as any health problems you have. This will help determine whether it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as narcolepsy (falling asleep unexpectedly) or liver problems.
If you are taking any sleep aids, including prescription or over-the-counter (OTC) medications, natural products, or supplements. If you are unsure about specific products, consult your doctor or pharmacist.
Any medications, including prescription and OTC drugs, natural products, or vitamins, that you are currently taking. This is crucial because some medications, such as those used to treat HIV, infections, seizures, and other conditions, may interact with this medication.
* Note that this is not an exhaustive list of all potential interactions. Therefore, it is vital to discuss all your medications and health conditions with your doctor.
To ensure your safety, inform your doctor and pharmacist about all your medications, including prescription and OTC drugs, natural products, and vitamins, as well as any health problems you have. This will help determine whether it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
After taking this drug, avoid driving and other activities that require alertness for at least 8 hours, or until you feel fully awake. You may still experience drowsiness the day after taking this medication, which can impair your driving abilities and increase the risk of falling asleep while driving. If you feel excessively sleepy during the day after taking this drug and plan to drive, consult your doctor.
Do not exceed the prescribed dose or frequency of this medication. If your sleep problems persist, contact your doctor. Long-term use of this drug may lead to dependence.
Avoid consuming alcohol while taking this medication, and do not take it if you have had alcohol that evening or before bedtime. Before using marijuana, other forms of cannabis, or prescription or over-the-counter drugs that may cause drowsiness, consult your doctor.
Some individuals have reported performing tasks, such as driving, cooking, eating, or having sex, while not fully awake, often without recalling these events. If this occurs, inform your doctor.
If you regularly consume grapefruit juice or eat grapefruit, discuss this with your doctor, as it may interact with the medication.
This drug can cause drowsiness and reduced alertness, increasing the risk of falls, particularly in older adults. If you have concerns, consult your doctor. Additionally, if you have sleep apnea, chronic obstructive pulmonary disease (COPD), or other breathing problems, discuss the potential effects of this medication on your breathing with your doctor.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding, as you will need to discuss the benefits and risks of this medication for both you and your baby.
After taking this drug, avoid driving and other activities that require alertness for at least 8 hours, or until you feel fully awake. You may still experience drowsiness the day after taking this medication, which can impair your driving abilities and increase the risk of falling asleep while driving. If you feel excessively sleepy during the day after taking this drug and plan to drive, consult your doctor.
Do not exceed the prescribed dose or frequency of this medication. If your sleep problems persist, contact your doctor. Long-term use of this drug may lead to dependence.
Avoid consuming alcohol while taking this medication, and do not take it if you have had alcohol that evening or before bedtime. Before using marijuana, other forms of cannabis, or prescription or over-the-counter drugs that may cause drowsiness, consult your doctor.
Some individuals have reported performing tasks, such as driving, cooking, eating, or having sex, while not fully awake, often without recalling these events. If this occurs, inform your doctor.
If you regularly consume grapefruit juice or eat grapefruit, discuss this with your doctor, as it may interact with the medication.
This drug can cause drowsiness and reduced alertness, increasing the risk of falls, particularly in older adults. If you have concerns, consult your doctor. Additionally, if you have sleep apnea, chronic obstructive pulmonary disease (COPD), or other breathing problems, discuss the potential effects of this medication on your breathing with your doctor.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding, as you will need to discuss the benefits and risks of this medication for both you and your baby.
Overdose Information
Overdose Symptoms:
- Somnolence
- Fatigue
- Headache
- Dizziness
- Nausea
What to Do:
In case of overdose, contact a poison control center immediately (e.g., call 1-800-222-1222 in the US) or seek emergency medical attention. Treatment should be symptomatic and supportive. Gastric lavage or activated charcoal may be considered if appropriate.
Drug Interactions
Contraindicated Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, cobicistat, indinavir, nelfinavir, saquinavir, telithromycin, conivaptan)
Major Interactions
- Moderate CYP3A4 inhibitors (e.g., fluconazole, diltiazem, erythromycin, verapamil, grapefruit juice) - reduce daridorexant dose to 25 mg
- Strong or moderate CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital, St. John's Wort, efavirenz) - avoid co-administration
Moderate Interactions
Confidence Interactions
Monitoring
Baseline Monitoring
Comprehensive sleep history and evaluation
Rationale: To rule out underlying sleep disorders (e.g., sleep apnea, restless legs syndrome) or psychiatric/medical conditions that may contribute to insomnia.
Timing: Prior to initiation of therapy
Mental health assessment
Rationale: To screen for depression or suicidal ideation, as insomnia may be a symptom of underlying depression, and treatment with hypnotics may unmask or worsen suicidal ideation.
Timing: Prior to initiation of therapy
Routine Monitoring
Efficacy of sleep improvement
Frequency: Periodically, as clinically indicated
Target: Improved sleep onset, sleep maintenance, and daytime functioning
Action Threshold: Lack of efficacy may warrant re-evaluation of diagnosis or treatment plan.
Adverse effects (e.g., somnolence, dizziness, headache, fatigue, nausea)
Frequency: Regularly, especially during initial treatment
Target: Absence or minimal severity of side effects
Action Threshold: Persistent or severe adverse effects may require dose reduction or discontinuation.
Signs of complex sleep behaviors (e.g., sleep-driving, sleep-eating, making phone calls while not fully awake)
Frequency: Regularly
Target: Absence of such behaviors
Action Threshold: If observed, discontinue daridorexant immediately.
Worsening depression or emergence of suicidal thoughts/behaviors
Frequency: Regularly, especially in patients with pre-existing psychiatric conditions
Target: Stable mood and absence of suicidal ideation
Action Threshold: Prompt psychiatric evaluation and intervention if observed.
Symptom Monitoring
- Daytime somnolence
- Dizziness
- Headache
- Fatigue
- Nausea
- Abnormal dreams
- Sleep paralysis
- Hypnagogic/hypnopompic hallucinations
- Complex sleep behaviors (e.g., sleep-driving, sleep-eating, preparing and eating food, making phone calls, having sex, sleepwalking)
- Worsening depression
- Suicidal ideation or behavior
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of daridorexant in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
No human data available; animal studies showed developmental toxicity at high doses.
Second Trimester:
No human data available.
Third Trimester:
No human data available.
Lactation
It is not known if daridorexant is excreted in human milk. Daridorexant and its metabolites were present in the milk of lactating rats. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for daridorexant and any potential adverse effects on the breastfed infant.
Infant Risk:
Unknown; potential for somnolence or other CNS depression in breastfed infant.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients (under 18 years of age).
Geriatric Use
No dose adjustment is required based on age alone. However, elderly patients may be more sensitive to the effects of hypnotics and should be monitored for adverse reactions such as falls, dizziness, and cognitive impairment. The 25 mg dose should be considered if there are concerns about tolerability.
Clinical Information
Clinical Pearls
- Instruct patients to take Quviviq only when they are able to get a full night's sleep (at least 7 hours) before they need to be active again.
- Advise patients that Quviviq may cause next-day impairment, including impaired driving. Patients should be cautioned against driving or engaging in other activities requiring complete mental alertness until they know how Quviviq affects them.
- Assess patients for underlying medical or psychiatric conditions that may contribute to insomnia, as Quviviq treats the symptom of insomnia but not its underlying cause.
- Patients should be warned about the risk of complex sleep behaviors, which can occur with or without memory of the event. If such behaviors occur, the drug should be discontinued.
- Quviviq is not indicated for the treatment of narcolepsy.
Alternative Therapies
- Other Dual Orexin Receptor Antagonists (e.g., Suvorexant, Lemborexant)
- GABA-A receptor agonists (e.g., Zolpidem, Eszopiclone, Zaleplon, Temazepam)
- Melatonin receptor agonists (e.g., Ramelteon)
- Antidepressants with sedating properties (e.g., low-dose Doxepin, Trazodone)
- Cognitive Behavioral Therapy for Insomnia (CBT-I)
Cost & Coverage
Average Cost:
$450 - $600 per 30 tablets
Insurance Coverage:
Tier 2 or Tier 3 (Brand-name prescription drug, may require prior authorization)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment.