Insomnia Hypersensitivity. Narcolepsy

Miscellaneous sedatives & hypnotics

Suvorexant is a highly selective antagonist for orexin receptors OX1R and OX2R. The mechanism by which Suvorexant exerts its therapeutic efect in insomnia is presumed to be through antagonism of orexin receptors. The orexin neuropeptide signaling system is a central promoter of wakefulness. Blocking the binding of wake-promoting neuropeptides orexin A and orexin B to receptors OX1R and OX2R is thought to suppress wake drive.

Administration: May be taken with or without food. Adult Dose: Insomnia Recommended starting dose: 10 mg PO taken no more than once per night and within 30 minutes of going to bed. Not to exceed 20 mg once daily. Hepatic impairment Mild-to-moderate: No dosage adjustment required Severe: Not recommended Child Dose: Safety and efficacy not established Renal Dose: Renal impairment: No dosage adjustment required

CNS-Active Drugs: An additive effect on psychomotor performance was observed when a single dose of 40 mg of Suvorexant was co-administered with a single dose of 0.7 g/kg alcohol. Suvorexant does not afect alcohol concentrations and alcohol does not afect Suvorexant concentrations.effect s of Other Drugs on Suvorexant: Strong (e.g., ketoconazole or itraconazole) and moderate (e.g., diltiazem) CYP3A inhibitors signifcantly increased Suvorexant exposure. Strong CYP3A inducers (e.g., rifampin) substantially decreases Suvorexant exposure.effect s of Suvorexant on Other Drugs: Suvorexant is unlikely to cause clinically signifcant inhibition of human CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 or CYP2D6. Chronic administration of Suvorexant is unlikely to induce the metabolism of drugs metabolized by major CYP isoforms.

Hypersensitivity. Narcolepsy

1-10% Somnolence, females (8%),Somnolence (7%),Headache (7%),Somnolence, males (3%),Dizziness (3%),Abnormal dreams (2%),Cough (2%), Diarrhea (2%),Dry mouth (2%),Upper respiratory tract infection (2%)

Pregnancy Category C. There is no adequate and well-controlled studies in pregnant women. Suvorexant should be used during pregnancy only if the potential beneft justifes the potential risk to the fetus.

Precaution: Can impair daytime wakefulness; CNS depressant effects can last for up to several days after discontinuation Can impair driving skills and may increase the risk of falling asleep while driving Dosage adjustments of suvorexant and concomitant CNS depressants may be necessary when administered together because of potentially additive effects Use with other drugs to treat insomnia is not recommended Risk of next-day impairment, including impaired driving, is increased if taken with less than a full night of sleep remaining, if a higher than the recommended dose is taken, if coadministered with other CNS depressants, or if coadministered with other drugs that increase suvorexant blood levels Dose-dependent increase in suicidal ideation was observed in patients taking suvorexant, as assessed by questionnaire; immediately evaluate patients with suicidal ideation or any new-onset behavioral changes; worsening depression or suicidal thinking, thoughts, and actions have been reported with the use of sedative-hypnotic Consider effect on respiratory function Risk of sleep paralysis, hypnagogic/hypnopompic hallucinations, and cataplexy-like symptoms increases with increasing doses Not recommended for patients with severe hepatic impairment

Store in dry and cool place, protect from light & keep away from children.

Miscellaneous sedatives & hypnotics

Orexin receptor antagonist; orexin, also called hypocretin, is a neurotransmitter that regulates arousal, wakefulness, and appetite Blocking the binding of wake-promoting neuropeptides orexin A and orexin B to receptors OX1R and OX2R is thought to suppress wake drive

Pregnancy Category C. There is no adequate and well-controlled studies in pregnant women. Suvorexant should be used during pregnancy only if the potential beneft justifes the potential risk to the fetus.