DARIDOREXANT

Class

• Dual orexin receptor antagonist (DORA); hypnotic

DARIDOREXANT commonly prescribed for

(Bold for FDA approved)

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

Notable Side Effects

• Sedation, headache

Life Threatening Side Effects

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

weight gain

unusual

sedation

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

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

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