SOLRIAMFETOL
Clinical safety rating: caution
Comprehensive clinical and safety monograph for SOLRIAMFETOL (SOLRIAMFETOL).
Solriamfetol is a selective dopamine and norepinephrine reuptake inhibitor (DNRI). It increases extracellular levels of dopamine and norepinephrine by blocking their reuptake via the dopamine transporter (DAT) and norepinephrine transporter (NET), respectively, without significant affinity for other monoamine transporters or receptors.
| Metabolism | Solriamfetol is minimally metabolized; approximately 95% of the dose is excreted unchanged in urine. Metabolism occurs via amide hydrolysis catalyzed by amidases, but no specific CYP enzymes are involved. |
| Excretion | Primarily renal excretion as unchanged drug and metabolites: 70-80% in urine, with about 30% unchanged; biliary/fecal elimination accounts for 15-20%. |
| Half-life | Terminal elimination half-life is 12-15 hours in healthy adults; may be prolonged in renal impairment (up to 30-40 hours) requiring dose adjustment. |
| Protein binding | Approximately 60-70% bound to albumin. |
| Volume of Distribution | Vd ~3-5 L/kg, indicating extensive tissue distribution. |
| Bioavailability | Oral bioavailability ~90% with minimal first-pass metabolism. |
| Onset of Action | Oral: 2-4 hours; peak effect at 4-6 hours. |
| Duration of Action | Approximately 12-24 hours; with chronic dosing, sustained wakefulness persists for the dosing interval. |
2.5 mg orally once daily, titrated to 5 mg daily after 2 weeks; maximum 7.5 mg daily.
| Dosage form | TABLET |
| Renal impairment | GFR ≥30 mL/min: no adjustment; GFR <30 mL/min: not recommended. |
| Liver impairment | Child-Pugh A: 2.5 mg daily; Child-Pugh B: not recommended; Child-Pugh C: contraindicated. |
| Pediatric use | Not approved for patients <18 years of age. |
| Geriatric use | Initial 2.5 mg daily; maximum 5 mg daily; monitor for orthostatic hypotension and cognitive effects. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for SOLRIAMFETOL (SOLRIAMFETOL).
| Breastfeeding | Excreted into breast milk; M/P ratio unknown. Use caution; monitor infant for sedation and poor feeding. Weigh benefits against risks. |
| Teratogenic Risk | First trimester: Limited human data; animal studies show increased risk of cardiovascular and skeletal malformations at supratherapeutic doses. Second/third trimester: No specific fetal risks documented; potential for neonatal withdrawal if used near term. |
| Fetal Monitoring |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
["Concomitant use with monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuing MAOIs.","Hypersensitivity to solriamfetol or any of its components."]
| Precautions | ["Blood pressure and heart rate increase: Monitor in patients with hypertension, cardiovascular disease, or arrhythmias.","Psychiatric symptoms: Caution in patients with a history of psychosis, mania, or bipolar disorder.","Seizures: Increased risk in patients with a history of seizure disorders.","Potential for abuse and dependence: Schedule IV controlled substance."] |
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| Monitor maternal blood pressure and heart rate throughout pregnancy. Fetal monitoring: serial growth ultrasounds and non-stress tests in third trimester. Assess for neonatal withdrawal post-delivery. |
| Fertility Effects | In animal studies, impaired spermatogenesis and reduced fertility at high doses. Human data limited; potential for transient effects on fertility in both sexes. |