suvorexant (Rx)

Brand and Other Names:Belsomra
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet: Schedule IV

  • 5mg
  • 10mg
  • 15mg
  • 20mg

Insomnia

Indicated for insomnia characterized by difficulties with sleep onset and/or sleep maintenance

Recommended starting dose: 10 mg PO taken no more than once per night and within 30 minutes of going to bed, with at least 7 hr remaining before the planned time of awakening

Use the lowest dose effective for the patient If 10 mg dose is well-tolerated but not effective, the dose can be increased

Not to exceed 20 mg once daily

Dosage Modifications

Renal impairment: No dosage adjustment required

Hepatic impairment

  • Mild-to-moderate: No dosage adjustment required
  • Severe: Not recommended

Coadministration with CYP3A4 inhibitors

  • Strong: Not recommended
  • Moderate: Decrease suvorexant recommended dose to 5 mg PO HS; if tolerated but not effective, may increase dose, not to exceed 10 mg/dose

Dosing Considerations

Systemic exposure increased in obese compared with nonobese patients, and in women compared with men

Particularly in obese women, the increased risk of exposure-related adverse effects should be considered before increasing the dose

Safety and efficacy not established

See adult dosing

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Interactions

Interaction Checker

and suvorexant

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            Adverse Effects

            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%)

            Postmarketing Reports

            Cardiac disorders: Palpitations, tachycardia

            Nervous system disorders: Psychomotor hyperactivity

            Psychiatric disorders: Anxiety

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            Warnings

            Contraindications

            Narcolepsy

            Cautions

            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

            Patients should not use suvorexant if they drank alcohol that evening or before bed; coadministration with other CNS depressants (eg, benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of CNS depression

            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

            Caution patients taking 20 mg to refrain from next-day driving and other activities requiring full mental alertness

            Reevaluate patients for comorbid conditions if insomnia persists after 7-10 days of treatment

            Cognitive and behavioral changes (eg, amnesia, anxiety, hallucinations, and other neuropsychiatric symptoms) reported with hypnotics; “sleep driving” and other complex behaviors (eg, preparing and eating food, making phone calls, or having sex), with amnesia for the event, have been reported

            The use of alcohol and other CNS depressants may increase the risk of cognitive changes listed above; discontinuation should be strongly considered

            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 or those taking a strong CYP3A inhibitor

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: Unknown if distributed in human breast milk

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            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

            Absorption

            Bioavailability: 82%

            Peak plasma time: 2 hr (range 30 min to 6 hr)

            Taking after a high-fat meal delays peak concentration by ~1.5 hr

            Distribution

            Protein bound: >99% to human serum albumin and α1-acid glycoprotein

            Not preferentially distribute into RBCs

            Vd: 49 L

            Metabolism

            Mainly eliminated by metabolism, primarily by CYP3A with a minor contribution from CYP2C19

            Metabolite: hydroxy-suvorexant (not active)

            Elimination

            Half-life: ~12 hr

            Excretion: 66% feces; 23% urine

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            Administration

            Oral Administration

            May take with or without food; however, for faster sleep onset, do not administer soon after a meal because food will delay the onset of action

            If alcohol consumed in the evening or before bed, do not take suvorexant

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
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            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.