Daridorexant

Daridorexant is a prescription medication used to treat insomnia characterized by difficulties with sleep onset and/or sleep maintenance. 

• Daridorexant is available under the following different brand names: Quviviq.

Common side effects of Daridorexant include:

• Headache or migraine headache, 
• Dizziness, 
• Nausea, 
• Vomiting,
• Tiredness, and
• Fatigue

Serious side effects of Daridorexant include:

• Hives, 
• Difficulty breathing, 
• Swelling of the face, lips, tongue, or throat, 
• Severe dizziness, 
• Sleepwalking (engaging in activities while not fully awake), 
• Increased depression, 
• Thoughts of self-harm, 
• Inability to move or speak as you wake up, 
• Hallucinations, 
• Weakness in the legs

Rare side effects of Daridorexant include:

• None 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Tablet: Schedule IV

• 25 mg
• 50 mg

Insomnia

Adult dosage

• 25-50 mg orally once per night

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Daridorexant has severe interactions with no other drugs.
• Daridorexant has serious interactions with at least 61 other drugs.
• Daridorexant has moderate interactions with at least 268 other drugs.
• Daridorexant has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Narcolepsy

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Daridorexant?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Daridorexant?”

Cautions

• Worsening depression or suicidal ideation may occur; caution in patients exhibiting symptoms of depression; monitor signs and symptoms of suicide and provide protective measures.
• Sleep paralysis (an inability to move or speak for up to several minutes during sleep-wake transitions) and hypnagogic/hypnopompic hallucinations (including vivid and disturbing perceptions) can occur; explain the nature of these events when prescribing.
• Cognitive and behavioral changes (. g, amnesia, anxiety, hallucinations, other neuropsychiatric symptoms) reported with hypnotics; “sleep-driving” and other complex behaviors (. g, preparing and eating food, making phone calls, having sex), with amnesia for the event, have been reported; discontinue therapy immediately if complex sleep behavior experienced.
• Consider effects on respiratory function if prescribed to patients with compromised respiratory function; not studied in patients with moderate obstructive sleep apnea (OSA) requiring continuous positive airway pressure, severe OSA, or severe chronic obstructive pulmonary disease.
• Reevaluate patients for comorbid conditions if insomnia persists after 7-10 days of treatment.
• CNS depressant effects
  • May impair daytime wakefulness, even when used as prescribed.
  • CNS-depressant effects may persist up to several days after discontinuing.
  • Advise patients of the potential for next-day somnolence
  • Increased risk of daytime impairment may occur if the dose is taken with less than a full night of sleep or with a higher than the recommended dose
  • Coadministration with other CNS depressants (. g, benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of CNS depression, which can cause daytime impairment
  • Dosage adjustments of Daridorexant and concomitant CNS depressants may be necessary when administered together because of potentially additive effects.
• Not recommended for concomitant use with other drugs for insomnia
• Alcohol consumption during therapy is not recommended.
• Patients, especially elderly individuals, may be at higher risk of falls owing to the potential for drowsiness.
• Symptoms similar to mild cataplexy reported with orexin receptor antagonists; such symptoms can include periods of leg weakness lasting from seconds to a few minutes, can occur either at night or during the day, and may not be associated with an identified triggering event (.g, laughter or surprise)
• Drug interaction overview
• Substrate of CYP3A4
  • Strong or moderate CYP3A4 inhibitors
  • Strong CYP3A4 inhibitors: Avoid coadministration.
  • Moderate CYP3A4 inhibitors: Not to exceed 25 mg/night.
  • Strong or moderate CYP3A4 inhibitors may increase exposure and risk of Daridorexant adverse reactions.
• Strong or moderate CYP3A4 inducers
  • Not recommended
  • Strong or moderate CYP3A4 inducers may decrease exposure and efficacy of Daridorexant.
• Alcohol and other CNS depressants
  • Avoid alcohol consumption.
  • Use with caution; consider a dosage adjustment of both Daridorexant and/or CNS depressants.
  • Alcohol and other CNS depressants may lead to additive impairment of psychomotor skills and risk of CNS depression.

Pregnancy and Lactation

• No data are available on use in pregnant females to evaluate for drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.
• Pregnancy exposure registry
• monitors pregnancy outcomes in females exposed to the drug during pregnancy.
• Encourage patients to call Idorsia Pharmaceutical Ltd. at 1-833-400-9611
• Lactation
• There are no data on the presence of the drug in human milk, its effects on breastfed infants, or its effects on milk production.
• Drug and metabolite are present i