Dr. Ahmed
Drug Name: Daridorexant
Brand Name: Quviviq
FDA Approval Date: 7th January 2022 [Ref]
Manufacturer: Idorsia Pharmaceuticals US Inc.
Primary Indication: Insomnia
Daridorexant (Quviviq) is an Orexin receptor inhibitor. It is a hypnotic drug that is used to induce sleep. Other drugs from the same class include:
Daridorexant (Quviviq) Uses:
Quviviq is a sleeping pill indicated only for the treatment of adults who have difficulty falling asleep or maintaining a sound sleep overnight.
It is not indicated for use in children, in combination with other sleeping pills, or for daytime siesta.
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Daridorexant (Quviviq) Dose:
The usual starting dose is 25 mg at bedtime or within 30 minutes of going to bed. The dose may be increased to 50 mg if no effect is seen with 25 mg.
It is recommended to be taken only once per night. Taking Quviviq with meals may delay its onset of action, hence, it is best to take 2 hours after the night meal.
Quviviq dose adjustment in various conditions:
Quviviq is metabolized by the liver enzyme CYP3A4 which is also involved in the metabolism of other medicines. The concentration and effects of Quviviq are altered by various drugs which are metabolized by the CYP3A4 pathway.
Use in combination with drugs that are either inducers or inhibitors of CYP3A4:
Avoid with Strong CYP3A4 inhibitors | Avoid with Strong CYP3A4 inducers |
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Reduce the dose of Quviviq to 25 mg when used with concomitant Moderate CYP3A4 inhibitors | Avoid with Moderate CYP3A4 inducers |
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Dose adjustment in liver disease:
Do not take it if you have severe hepatic impairment. In cases of moderate hepatic impairment, reduce the dose to a maximum of 25 mg per day.
Use in pregnancy and breastfeeding:
Data is not available in pregnant and lactating mothers. Any exposure during pregnancy should be reported. If used during breastfeeding, the child should be monitored for excessive sleepiness.
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Daridorexant (Quviviq) Contraindications and Warnings:
It should be avoided in individuals with Narcolepsy, a condition characterized by daytime sleepiness.
CNS depressant effects:
Quviviq inhibits wakefulness and induces sleep. Patients are likely to develop daytime sleepiness or impairment in cognition and perform higher motor functions such as driving or operating heavy machinery.
In addition to their impaired ability to perform these tasks, individuals taking Quviviq may also put themselves and the life of other people at risk.
It is, therefore, not recommended to perform these tasks. Alcohol and other CNS depressants may have an additive effect when used with Quviviq and so result in more daytime drowsiness.
The concomitant use of Quiviviq with other CNS depressants should be avoided.
Suicidal thoughts and Depression:
Quviviq blocks the Orexin receptors which are involved in the reward systems and mood apart from its inhibitory effects on wakefulness.
It may worsen underlying depression or induce mood changes that can progress to a state of suicidal ideas and thoughts.
The drug, like other hypnotic drugs, should be given with caution to patients with underlying depression. Patients on Quviviq must be warned to report any symptoms that may trigger suicide.
Sleepwalking and cataplexy:
Abnormal sleep patterns, cataplexy, and motor weakness may occur with treatment. Cataplexy is a transient loss of muscle power or tone that has been observed with Orexin inhibitors including Quviviq.
Complex sleeping behaviors:
Quviviq users have reported abnormal sleeping behaviors including sleepwalking, making phone calls, having sex, and indulging in other activities including criminal ones.
These events may occur after the first dose or after subsequent doses. The patient usually does not remember these events.
If a family member of the person reports any such behavior, Quviviq treatment should be stopped.
Sleep apnea:
Sleeping pills including Quviviq are not indicated for use in patients with sleep apnea of moderate to severe intensity.
It has not been studied in patients with chronic lung conditions, however, it is best to avoid it in conditions like severe uncontrolled asthma, COPD, and ILD because of the risk of respiratory depression.
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Quviviq Side Effects:
In clinical trials, the following side effects were commonly observed [Ref]:
CNS-related side effects:
- Headache including tension headache, and migraine headache with or without aura
- Fatigue, tiredness, and lethargy
- Sleepiness and sedation
- Dizziness including vertigo
GI side effects:
- Nausea and vomiting
Other rare side effects included sleep paralysis and hallucinations
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Daridorexant (Quviviq) Mechanism of Action (MOA):
Daridorexant blocks the binding of Orexin A and Orexin B to its receptors, OX1R and OX2R. Neuronal transmission from these neuropeptides is involved in multiple body processes, including:
- Wakefulness
- Reward
- Mood
- energy consumption, and
- Feeding Behaviors [Ref]
By blocking neuronal transmission mediated by Orexin receptors, Quviviq induces sleep, apart from other effects.
Effect on QT interval: No effect when administered in the usual doses
Co-administration with Alcohol: The effects of Quviviq and alcohol are additive, however, the blood levels of alcohol or the drug are not altered when they are used in combination
Co-administration with Citalopram: The combined use of Quviviq and Citalopram did not alter the blood levels or had any significant psychomotor effects.
Maximum Plasma Concentration: 1 – 2 hours of administration
Bioavailability: 62%
Effect of food on its absorption: Absorption of Quviviq is delayed by about 1.3 hours.
Metabolism: Extensively metabolized by CYP3A4 (up to 89% is metabolized by this enzyme pathway).
Excretion: 57% via feces, 28% via urine
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