suvorexant BELSOMRA
Class: Dual Orexin Receptor AntagonistsFDA Indications: Insomnia
Off-Label Use: NONE
Prescribing
FDA Schedule IVForms: 5, 10, 15, 20mg tablet
Dose Range: 5-20 mg/day
Starting: Recommended dose is 10 mg, 30 min prior to going to bed, with at least 7° remaining before the planned time of awakening. If the 10 mg dose is well-tolerated but not effective, the dose can be ↑'d to 20 mg
Precautions
Contraindications: Do not use in patients with narcolepsySerious Side Effects: Nighttime "sleep-driving" and other complex behaviors while out of bed and not fully awake. Risk increases with dose, with use of CNS depressants, and with alcohol.
Side Effects: sedation/somnolence
Pharmacokinetics
t½: 12° TMAX: 2°Substrate of: 3A4; 2C19
Inhibits: ∅ ; Induces: ∅
Active Metabolites: ∅
DDIs
- - CNS depression with combined use of opioids & other CNS depressants
- - recommended dose is 5 mg when used with moderate 3A4 inhibitors
- - dose can be ↑'d to 10 mg qd if the 5 mg dose is not effective
- - 3A4 inhibitors can ↑ levels; likewise, 3A4 inducers can ↓ levels
Misc
- - ∅ rebound insomnia or risk of dependence
- - some experience a daytime "hangover"
- - FDAs recommended cautious dose ↑ in obese females with a noted ↑ in AUC and Cmax by 46% & 25%, respectively
Special Populations
Category C—Based on animal data, may cause fetal harm
Suvorexant & its hydroxyl-suvorexant metabolite were excreted in rat milk at levels higher (9 & 1.5 times, respectively) than that in maternal plasma. It is not known whether this drug is secreted in human milk
No dosage adjustment necessary
No dosage adjustment necessary
Not recommended in severe hepatic impairment
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