Classes
DEA Class; Rx
Common Brand Names; Belsomra
- Sedative/Hypnotics;
- Orexin Antagonists
Description
Used in adults with insomnia characterized by difficulties with sleep onset and/or sleep maintenance
May cause worsening of depression, suicidality, or complex sleep-related behaviors; adult females or obese patients may have increased exposure to the drug’s effects at usual doses
Indications
Indicated for insomnia characterized by difficulties with sleep onset and/or sleep maintenance
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
Contraindications
Narcolepsy
Adverse Effects
- 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%)
Warnings
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
Pregnancy and Lactation
Available data from postmarketing reports in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes
There are no data on presence of drug in human milk, effects on breastfed infant or on milk production; drug and metabolite are present in rat milk; when drug is present in animal milk, it is likely that the drug will be present in human milk
Maximum Dosage
20 mg/day PO.
20 mg/day PO.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Not indicated.
Not indicated.
How supplied
suvorexant
tablet: Schedule IV
- 5mg
- 10mg
- 15mg
- 20mg