SUVOREXANT

Class

• Dual orexin receptor antagonist (DORA); hypnotic

SUVOREXANT commonly prescribed for

(Bold for FDA approved)

How SUVOREXANT works

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

How long until SUVOREXANT works

• Generally takes effect in less than an hour

Notable Side Effects

• Sedation, headache, dizziness, abnormal dreams

Life Threatening Side Effects

• Sleep paralysis and hypnagogic/ hypnopompic hallucinations (rare)

• Dose-dependent symptoms similar to mild cataplexy (rare)

weight gain

unusual

sedation

common

What to do about SUVOREXANT side effects

• Wait

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

• Lower the dose

• Switch to a different hypnotic

usual dosage range

• 10 mg/night

Dosage Forms

• Tablet 5 mg, 10 mg, 15 mg, 20 mg

long term use

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

habit forming

• Suvorexant is a Schedule IV drug

• There was no evidence of physiological dependence or withdrawal symptoms with prolonged use of suvorexant

Renal Impairment

• Dose adjustment not necessary

Hepatic Impairment

• Dose adjustment not necessary in mild to moderate hepatic impairment

• Not recommended in patients with severe hepatic impairment

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

• Effective June 30, 2015, the FDA requires changes to the content and format of pregnancy and lactation information in prescription drug labels, including the elimination of the pregnancy letter categories; the Pregnancy and Lactation Labeling Rule (PLLR or final rule) applies only to prescription drugs and will be phased in gradually for drugs approved on or after June 30, 2001

• Controlled studies have not been conducted in pregnant women

• When administered during organogenesis, the no observed adverse effect levels (NOAELs) for fetal toxicity are 25 and 28 times the maximum recommended human dose (MRHD) based on AUC in rats and rabbits, respectively

• When administered during pregnancy and lactation, the NOAEL for developmental toxicity is 25 times the MRHD based on AUC in rats

Breast Feeding

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

• Recommended to either discontinue drug or bottle feed