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DARIDOREXANT

ClassDARIDOREXANT commonly prescribed forHow DARIDOREXANT worksHow long until DARIDOREXANT worksNotable Side EffectsLife Threatening Side Effectsweight gainsedationWhat to do about DARIDOREXANT side effectsusual dosage rangeDosage Formslong term usehabit formingRenal ImpairmentHepatic ImpairmentCardiac ImpairmentElderlyChildren and AdolescentsPregnancyBreast Feeding

THERAPEUTICS

Class

  • Dual orexin receptor antagonist (DORA); hypnotic

DARIDOREXANT commonly prescribed for

(Bold for FDA approved)

• Insomnia (problems with sleep onset and/ or maintenance)

How DARIDOREXANT works

• Orexin serves to stabilize and promote wakefulness; daridorexant binds to orexin 1 and orexin 2 receptors, blocking orexin from binding there and thus preventing it from promoting wakefulness

How long until DARIDOREXANT works

• Generally takes effect in less than an hour

SIDE EFFECTS

Notable Side Effects

• Sedation, headache

Life Threatening Side Effects

• Sleep paralysis, hypnagogic/hypnopompic hallucinations, and cataplexy-like symptoms (rare)

weight gain

unusual

unusual

sedation

common

common

What to do about DARIDOREXANT side effects

• Wait

• To avoid problems with memory, take daridorexant only if planning to have a full night’s sleep

• Lower the dose

• Switch to a different hypnotic

DOSING AND USE

usual dosage range

• 25–50 mg/night

Dosage Forms

• Tablet 25 mg, 50 mg

long term use

• Has been evaluated and found effective in trials up to 1 year

habit forming

• Schedule IV drug

• No evidence of physiological dependence or withdrawal symptoms in clinical trials

SPECIAL POPULATIONS

Renal Impairment

• Dose adjustment not necessary

Hepatic Impairment

• Dose adjustment not necessary for mild hepatic impairment

• Maximum recommended dose is 25 mg/ night for moderate hepatic impairment (Child–Pugh score 7–9)

• Not recommended for patients with severe hepatic impairment (Child–Pugh score ≥10)

Cardiac Impairment

• Not studied in patients with cardiac impairment

Elderly

• Some patients may tolerate lower doses better

Children and Adolescents

• Safety and efficacy have not been established

Pregnancy

• Controlled studies have not been conducted in pregnant women

• When administered during organogenesis, the no observed adverse effect levels (NOAELs) for fetal toxicity are approximately 8 and 10 times the maximum recommended human dose (MRHD) based on AUC in rats and rabbits, respectively

• When administered during organogenesis, the NOAELs for maternal toxicity are approximately 8 and 4 times the MRHD based on AUC in rats and rabbits, respectively

• When administered during pregnancy and lactation, the NOAEL for maternal and developmental toxicity is 9 times the MRHD based on AUC in rats

Breast Feeding

Unknown if daridorexant is secreted in human breast milk, but all psychotropics are assumed to be secreted in breast milk

• Recommended either to discontinue drug or formula feed

Based on data Published online by Cambridge University Press

Compiled by Dr. Jash Ajmera