- Daridorexant hydrochloride is central nervous system (CNS) depressant that can impair daytime wakefulness even when used as prescribed.
- CNS-depressant effects may persist in some patients for up to several days after discontinuing daridorexant hydrochloride. Advise patients about the potential for next-day somnolence.
- Driving ability was impaired in some subjects taking daridorexant hydrochloride 50 mg.
- The risk of daytime impairment is increased if daridorexant hydrochloride is taken with less than a full night of sleep remaining or if a higher than recommended dose is taken.
- If it is taken in these circumstances, avoid driving and other activities requiring complete mental alertness.
- Co-administration with other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of CNS depression, which can cause daytime impairment.
- Dosage adjustments of daridorexant hydrochloride and of concomitant CNS depressants may be necessary when administered together because of potentially additive effects.
- The use of daridorexant hydrochloride with other drugs to treat insomnia is not recommended.
- No consumption of alcohol in combination with daridorexant hydrochloride as it resulted in additive effects on psychomotor performanc.
- Can cause drowsiness, hence patients, particularly the elderly, are at a higher risk of falls.
- Discontinue immediately if a patient experiences a complex sleep behavior.
- Not been studied in patients with severe COPD, moderate OSA requiring CPAP or severe OSA.
Cautions: Use cautiously in
- Patients exhibiting symptoms of depression. Monitoring of suicide risk and protective measures may be required.
- Sleep paralysis, hypnagogic/hypnopompic hallucinations, mild cataplexy-like symptoms
Interaction
- Strong CYP3A4 inhibitors: Avoid concomitant use
- Moderate CYP3A4 inhibitors: Maximum recommended dose is 25 mg PO.
- Moderate or Strong CYP3A4 inducers: Avoid concomitant use
Pregnancy Category:NR. There are no available data on QUVIVIQ use in pregnant women to evaluate for drug-associated risks of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.
Breastfeeding: Safety unknown; there are no data on the presence of daridorexant in human milk, the effects on the breastfed infant, or the effects on milk production. Daridorexant and its metabolites were present in the milk of lactating rats. When a drug is present in animal milk, it is likely that the drug will be present in human milk.
