Quviviq 25mg Tablets
It is used to treat sleep problems.
Drug Class
Hypnotic
Pharmacologic Class
Dual Orexin Receptor Antagonist (DORA)
Pregnancy Category
Not assigned; potential fetal harm based on animal data
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 (insomnia). It works by blocking certain brain chemicals that promote wakefulness, helping you fall asleep and stay asleep. It is not a sleeping pill in the traditional sense, but rather helps your brain switch from being awake to being asleep.
How to Use This Medicine
Taking Your Medication
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 (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. If you have questions about 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 (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. If you have questions about 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 exactly as prescribed, usually once a night, within 30 minutes before going to bed.
- Ensure you have at least 7 hours available for sleep after taking the medication.
- Do not take Quviviq with food or immediately after a meal, as this may delay its effect.
- Avoid alcohol consumption while taking Quviviq, as it can increase drowsiness and other side effects.
- Avoid driving or operating heavy machinery until you know how Quviviq affects you, as it may cause next-day drowsiness.
- Practice good sleep hygiene (e.g., consistent sleep schedule, comfortable sleep environment, avoiding caffeine/heavy meals before bed, regular exercise).
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
25 mg orally once nightly, within 30 minutes of going to bed, with at least 7 hours remaining before planned awakening.
Dose Range:
25 - 25 mg
Condition-Specific Dosing:
moderate_cyp3a4_inhibitors:
10 mg orally 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; use with caution
Hepatic Impairment:
Mild:
No dose adjustment needed (Child-Pugh A)
Moderate:
10 mg orally 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 the wake-promoting neuropeptides orexin A and orexin B to their receptors, OX1R and OX2R. By blocking the activation of orexin receptors, daridorexant suppresses wakefulness, thereby promoting sleep.
Pharmacokinetics
Absorption:
Bioavailability:
Not explicitly quantified as a percentage, but rapidly absorbed.
Tmax:
1-2 hours
FoodEffect:
High-fat, high-calorie meal delays Tmax by approximately 1.5 hours and decreases Cmax by 23%.
Distribution:
Vd:
Approximately 800 L
ProteinBinding:
>99%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 8 hours
Clearance:
Not available
ExcretionRoute:
Feces (approximately 60%), urine (approximately 30%)
Unchanged:
<1% (in urine)
Pharmacodynamics
OnsetOfAction:
Within 30 minutes (time to sleep onset)
PeakEffect:
Approximately 1-2 hours (consistent with Tmax)
DurationOfAction:
Approximately 8 hours
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help 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
+ Thoughts of suicide
Hallucinations (seeing or hearing things that are not there) while falling asleep or waking up
Temporary inability to move or speak, which can last from seconds to several minutes, and may occur while falling asleep or waking up
Muscle weakness, which can occur at any time, including at night or during the day, and can last from seconds to a few 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 any of the following side effects or if they persist or bother you:
Feeling sleepy the next day
Headache
Feeling tired or weak
Note: This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can provide medical advice about side effects.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help 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
+ Thoughts of suicide
Hallucinations (seeing or hearing things that are not there) while falling asleep or waking up
Temporary inability to move or speak, which can last from seconds to several minutes, and may occur while falling asleep or waking up
Muscle weakness, which can occur at any time, including at night or during the day, and can last from seconds to a few 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 any of the following side effects or if they persist or bother you:
Feeling sleepy the next day
Headache
Feeling tired or weak
Note: This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can provide medical advice about side effects.
Seek Immediate Medical Attention If You Experience:
- Excessive daytime sleepiness or drowsiness
- Dizziness or lightheadedness
- Nausea
- Headache
- Abnormal dreams or nightmares
- Sleep paralysis (inability to move or speak for a few minutes upon waking or falling asleep)
- Hypnagogic/hypnopompic hallucinations (seeing or hearing things that are not real while falling asleep or waking up)
- Any new or worsening thoughts of self-harm or depression
- Unusual or dangerous behaviors while asleep (e.g., sleep-driving, sleep-eating, making phone calls, walking) - if these occur, stop taking the medication and contact your doctor immediately.
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, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
Certain health conditions, including:
+ Narcolepsy (falling asleep unexpectedly)
+ Liver problems
Use of 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.
Concurrent use of other medications, including prescription and OTC drugs, natural products, and vitamins, that may interact with this medication. This is particularly important for certain medications used to treat:
+ HIV
+ Infections
+ Seizures
+ Other conditions
Please note that this is not an exhaustive list of interacting medications or health problems.
To ensure safe use, it is crucial to provide your doctor and pharmacist with a comprehensive list of all your medications (prescription and OTC), natural products, vitamins, and health problems. This will help determine whether it is safe to take this medication with your existing regimen. Never start, stop, or adjust 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, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
Certain health conditions, including:
+ Narcolepsy (falling asleep unexpectedly)
+ Liver problems
Use of 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.
Concurrent use of other medications, including prescription and OTC drugs, natural products, and vitamins, that may interact with this medication. This is particularly important for certain medications used to treat:
+ HIV
+ Infections
+ Seizures
+ Other conditions
Please note that this is not an exhaustive list of interacting medications or health problems.
To ensure safe use, it is crucial to provide your doctor and pharmacist with a comprehensive list of all your medications (prescription and OTC), natural products, vitamins, and health problems. This will help determine whether it is safe to take this medication with your existing regimen. Never start, stop, or adjust 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. Be aware that you may still experience drowsiness the day after taking this medication, which can impair your ability to drive and increase the risk of falling asleep while driving. If you experience excessive daytime sleepiness and drive, consult your doctor.
Do not exceed the prescribed dose or frequency of this medication. If your sleep problems persist, contact your doctor. Prolonged 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 in the evening or before bedtime. Before using marijuana, cannabis, or other prescription or over-the-counter medications that may cause drowsiness, consult your doctor.
Some individuals may perform tasks, such as driving, eating, or having sex, while not fully awake, often without remembering 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 or older, use this medication with caution, as you may be more susceptible to side effects.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks to 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. Be aware that you may still experience drowsiness the day after taking this medication, which can impair your ability to drive and increase the risk of falling asleep while driving. If you experience excessive daytime sleepiness and drive, consult your doctor.
Do not exceed the prescribed dose or frequency of this medication. If your sleep problems persist, contact your doctor. Prolonged 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 in the evening or before bedtime. Before using marijuana, cannabis, or other prescription or over-the-counter medications that may cause drowsiness, consult your doctor.
Some individuals may perform tasks, such as driving, eating, or having sex, while not fully awake, often without remembering 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 or older, use this medication with caution, as you may be more susceptible to side effects.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby.
Overdose Information
Overdose Symptoms:
- Somnolence (drowsiness)
- Sedation
- Fatigue
- Dizziness
- Headache
- Confusion
- Disorientation
- Slurred speech
- Ataxia (loss of coordination)
- Hypotension (low blood pressure)
- Respiratory depression (slow, shallow breathing)
- Coma
What to Do:
In case of suspected overdose, seek immediate medical attention or call a poison control center (1-800-222-1222). Management is primarily supportive, including monitoring vital signs, gastric lavage if appropriate, and general symptomatic and supportive measures. There is no specific antidote.
Drug Interactions
Contraindicated Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, cobicistat)
Major Interactions
Moderate Interactions
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort) - may significantly decrease daridorexant exposure and efficacy
- Other drugs metabolized by CYP3A4 (potential for altered metabolism)
Confidence Interactions
Monitoring
Baseline Monitoring
Insomnia severity and characteristics
Rationale: To establish baseline and assess treatment efficacy.
Timing: Prior to initiation
Sleep hygiene practices
Rationale: To identify and address contributing factors to insomnia.
Timing: Prior to initiation
Comorbid psychiatric conditions (e.g., depression, anxiety)
Rationale: To assess for underlying conditions that may worsen with treatment or require separate management.
Timing: Prior to initiation
Respiratory function (e.g., sleep apnea)
Rationale: To assess for conditions that may be exacerbated by CNS depressants.
Timing: Prior to initiation
Routine Monitoring
Efficacy (sleep onset, sleep maintenance, total sleep time)
Frequency: Periodically, as clinically indicated (e.g., 2-4 weeks after initiation, then every few months)
Target: Improved sleep parameters
Action Threshold: Lack of improvement or worsening of insomnia may require re-evaluation of treatment plan.
Adverse effects (e.g., daytime somnolence, dizziness, fatigue, abnormal dreams, sleep paralysis, hypnagogic/hypnopompic hallucinations)
Frequency: Regularly, especially during initial weeks of therapy and with dose changes
Target: Absence or tolerability of side effects
Action Threshold: Persistent or severe adverse effects may require dose reduction or discontinuation.
Signs of worsening depression or suicidal ideation
Frequency: Regularly, especially in patients with pre-existing psychiatric conditions
Target: Stable mood, absence of suicidal ideation
Action Threshold: Any new or worsening psychiatric symptoms require immediate clinical evaluation.
Complex sleep behaviors (e.g., sleep-driving, sleep-eating)
Frequency: Patient and caregiver education and inquiry at follow-up visits
Target: Absence of such behaviors
Action Threshold: Occurrence requires immediate discontinuation.
Symptom Monitoring
- Daytime somnolence
- Dizziness
- Fatigue
- Headache
- Nausea
- Abnormal dreams
- Sleep paralysis
- Hypnagogic/hypnopompic hallucinations
- Symptoms of worsening depression or suicidal thoughts
- Unusual behaviors during sleep (e.g., sleep-driving, sleep-eating, making phone calls while not fully awake)
Special Patient Groups
Pregnancy
Quviviq is not recommended during pregnancy. Animal studies have shown adverse developmental effects (e.g., skeletal abnormalities, reduced fetal weight) at exposures higher than those achieved clinically. There are no adequate and well-controlled studies in pregnant women.
Trimester-Specific Risks:
First Trimester:
Potential for fetal harm based on animal data.
Second Trimester:
Potential for fetal harm based on animal data.
Third Trimester:
Potential for fetal harm based on animal data; risk of CNS depression in neonate if used late in pregnancy.
Lactation
It is not known if daridorexant is excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, breastfeeding is not recommended during treatment with Quviviq.
Infant Risk:
Moderate risk (L3) - potential for sedation, poor feeding, and other CNS effects in the infant. Consider alternatives or discontinue breastfeeding.
Pediatric Use
Safety and effectiveness of Quviviq have not been established in pediatric patients (under 18 years of age).
Geriatric Use
No dose adjustment is required for elderly patients. However, elderly patients may be more sensitive to the effects of Quviviq, particularly the risk of falls and cognitive impairment due to residual daytime somnolence. Use with caution and monitor closely for adverse effects.
Clinical Information
Clinical Pearls
- Daridorexant is a non-controlled substance, offering an alternative to controlled hypnotics for chronic insomnia.
- Unlike benzodiazepine receptor agonists, DORAs like daridorexant do not appear to cause physical dependence or withdrawal symptoms upon discontinuation.
- Patients should be advised to take the medication only when they can dedicate at least 7 hours to sleep, to minimize next-day residual effects.
- The onset of action may be delayed if taken with or immediately after a meal.
- It is important to rule out underlying medical or psychiatric conditions contributing to insomnia before initiating treatment with daridorexant.
Alternative Therapies
- Other Dual Orexin Receptor Antagonists (DORAs): Lemborexant (Dayvigo), Suvorexant (Belsomra)
- GABA-A receptor agonists (Z-drugs): Zolpidem (Ambien), Eszopiclone (Lunesta), Zaleplon (Sonata)
- Melatonin receptor agonists: Ramelteon (Rozerem)
- Antidepressants with sedative properties: Trazodone, Doxepin (Silenor)
- Benzodiazepines: Temazepam (Restoril), Triazolam (Halcion)
- Cognitive Behavioral Therapy for Insomnia (CBT-I) - often considered first-line non-pharmacological treatment.
Cost & Coverage
Average Cost:
$450 - $550 per 30 tablets (25mg)
Insurance Coverage:
Tier 2 or Tier 3 (Brand-name drug, often requires prior authorization or step therapy)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult 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.