Suvorexant (2 brand names, 1 dosage form, 1 route)
Available dosage forms: TABLET.
Routes of administration: ORAL.
Brand Names
- BELSOMRA
- SUVOREXANT
Indications and Usage
BELSOMRA® (suvorexant) is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.
Contraindications
BELSOMRA is contraindicated in patients with narcolepsy.
Adverse Reactions
The following serious adverse reactions are discussed in greater detail in other sections: CNS Depressant Effects and Daytime Impairment [see Warnings and Precautions (5.1)] Worsening of Depression/Suicidal Ideation [see Warnings and Precautions (5.2)] Complex Sleep Behaviors [see Warnings and Precautions (5.3)] Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, Cataplexy-Like Symptoms [see Warnings and Precautions (5.4)] Patients with Compromised Respiratory Function [see Warnings and Precautions (5.5)]
Mechanism of Action
The mechanism of action of suvorexant in the treatment of insomnia is presumed to be through antagonism of orexin receptors. The orexin neuropeptide signaling system plays a role in wakefulness. Blocking the binding of wake-promoting neuropeptides orexin A and orexin B to receptors OX1R and OX2R is thought to suppress wake drive.
Overdosage
There is limited premarketing clinical experience with an overdosage of BELSOMRA. In clinical pharmacology studies, healthy subjects who were administered morning doses of up to 240 mg of suvorexant showed dose-dependent increases in the frequency and duration of somnolence. General symptomatic and supportive measures should be used, along with immediate gastric lavage where appropriate. Intravenous fluids should be administered as needed. As in all cases of drug overdose, vital signs should be monitored and general supportive measures employed. The value of dialysis in the treatment of overdosage has not been determined. As suvorexant is highly protein-bound, hemodialysis is not expected to contribute to elimination of suvorexant. As with the management of all overdosage, the possibility of multiple drug ingestion should be considered. Consider contacting a poison control center for up-to-date information on the management of hypnotic drug product overdosage.