Suvorexant

Suvorexant is used to treat insomnia.

Suvorexant is available under the following different brand names: Belsomra.

Tablet: Schedule IV

• 5 mg
• 10 mg
• 15 mg
• 20 mg

Dosage Considerations – Should be Given as Follows:

Insomnia

• Indicated for insomnia characterized by difficulties with sleep onset and/or sleep maintenance
• Recommended starting dose: 10 mg orally taken no more than once per night and within 30 minutes of going to bed, with at least 7 hours 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 orally at night; 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
• The safety and efficacy of suvorexant for pediatric patients have not been established.

Common side effects of suvorexant include:

• Drowsiness/sleepiness
• Headache
• Dizziness
• Abnormal dreams
• Cough
• Diarrhea
• Dry mouth
• Upper respiratory tract infection

Postmarketing side effects of suvorexant reported include:

• Palpitations
• Fast heart rate
• Psychomotor hyperactivity
• Anxiety

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Suvorexant has no listed severe interactions with other drugs.
• Suvorexant has serious interactions with at least 40 different drugs.
• Suvorexant has moderate interactions with at least 108 different drugs.
• Suvorexant has mild interactions with at least 101 different drugs.

Warnings

This medication contains suvorexant. Do not take Belsomra if you are allergic to suvorexant or any ingredients contained in this drug.

Contraindications

• Narcolepsy

Effects of Drug Abuse

• No information available.

Short-Term Effects

• See "What Are Side Effects Associated with Using Suvorexant?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Suvorexant?"

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 (e.g., 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 (e.g., amnesia, anxiety, hallucinations, and other neuropsychiatric symptoms) reported with hypnotics; “sleep driving” and other complex behaviors (e.g., 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

Pregnancy and Lactation

Use suvorexant with caution during pregnancy if benefits outweigh risks. Animal studies show risk and human studies are not available or neither animal nor human studies were done. It is unknown if suvorexant is distributed in human breast milk; consult your doctor before breastfeeding.