SUNOSI

Clinical safety rating: caution

Comprehensive clinical and safety monograph for SUNOSI (SUNOSI).

How it works

Selective dopamine and norepinephrine reuptake inhibitor; also acts as a TAAR1 agonist, increasing cAMP levels in monoamine neurons.

What the body does with it

Metabolism	Primarily via CYP3A4; also CYP2D6 and CYP2C19 to a lesser extent. Main metabolite is desmethyl-solriamfetol (active).
Excretion	Primarily renal elimination (approximately 95% as unchanged drug and metabolites); biliary/fecal excretion accounts for <5%.
Half-life	Terminal elimination half-life is approximately 9.5 hours in healthy adults; clinically relevant for once-daily dosing.
Protein binding	Approximately 40% bound to plasma proteins (primarily albumin).
Volume of Distribution	Volume of distribution is approximately 2.7 L/kg, indicating extensive tissue distribution.
Bioavailability	Oral bioavailability is approximately 95%, indicating high systemic absorption after oral administration.
Onset of Action	Oral: Onset of clinical effect (wakefulness) occurs within 1-2 hours post-dose.
Duration of Action	Duration of clinical effect is approximately 12-15 hours, supporting once-daily dosing; may vary based on individual metabolism.

Classification & Brands

Dosing & administration

75 mg orally once daily upon awakening.

Dosage form	TABLET
Renal impairment	GFR 30-89 mL/min: 75 mg once daily; GFR 15-29 mL/min: 37.5 mg once daily; GFR <15 mL/min or ESRD: not recommended.
Liver impairment	Child-Pugh A or B: no adjustment; Child-Pugh C: not recommended.
Pediatric use	Not approved for pediatric use; no established pediatric dosing.
Geriatric use	No specific adjustment, but caution due to potential increased sensitivity; monitor for adverse effects.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for SUNOSI (SUNOSI).

Breastfeeding

No data on presence in human milk, effects on breastfed infant, or milk production. M/P ratio not available. Due to molecular weight (approximately 270 Da) and high protein binding (97%), excretion is likely minimal but not confirmed. Caution advised; consider alternative therapies or pump and discard during treatment.

Teratogenic Risk

In animal studies, solriamfetol (SUNOSI) administered during organogenesis resulted in developmental toxicity including increased fetal malformations (cardiac, skeletal) at exposures 3 times the maximum recommended human dose (MRHD). Data in pregnant women are insufficient. In first trimester, risk cannot be excluded; in second and third trimesters, potential for adverse effects on fetal growth and CNS development due to noradrenergic effects. Use only if potential benefit justifies risk.

Warnings & precautions

■ FDA Black Box Warning

None

Side Effect Profile

Serious Effects

Absolute Contraindications

["Concomitant use of monoamine oxidase inhibitors (MAOIs) or within 14 days of MAOI use","Uncontrolled hypertension or tachyarrhythmias","History of seizure disorder"]

Clinical Precautions

Precautions

["Hypertension (may increase heart rate and blood pressure, especially in patients with pre-existing hypertension)","Psychiatric symptoms (anxiety, insomnia, agitation; caution in patients with history of psychosis or bipolar disorder)","Seizures (potential to lower seizure threshold; avoid in patients with seizure disorders)","Potential for abuse and dependence (schedule IV controlled substance; monitor for signs of misuse)"]

Clinical Tips & Counseling

Drug interactions

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SUNOSI

Clinical safety rating: caution

Comprehensive clinical and safety monograph for SUNOSI (SUNOSI).

How it works

Selective dopamine and norepinephrine reuptake inhibitor; also acts as a TAAR1 agonist, increasing cAMP levels in monoamine neurons.

What the body does with it

Metabolism	Primarily via CYP3A4; also CYP2D6 and CYP2C19 to a lesser extent. Main metabolite is desmethyl-solriamfetol (active).
Excretion	Primarily renal elimination (approximately 95% as unchanged drug and metabolites); biliary/fecal excretion accounts for <5%.
Half-life	Terminal elimination half-life is approximately 9.5 hours in healthy adults; clinically relevant for once-daily dosing.
Protein binding	Approximately 40% bound to plasma proteins (primarily albumin).
Volume of Distribution	Volume of distribution is approximately 2.7 L/kg, indicating extensive tissue distribution.
Bioavailability	Oral bioavailability is approximately 95%, indicating high systemic absorption after oral administration.
Onset of Action	Oral: Onset of clinical effect (wakefulness) occurs within 1-2 hours post-dose.
Duration of Action	Duration of clinical effect is approximately 12-15 hours, supporting once-daily dosing; may vary based on individual metabolism.

Classification & Brands

Dosing & administration

75 mg orally once daily upon awakening.

Dosage form	TABLET
Renal impairment	GFR 30-89 mL/min: 75 mg once daily; GFR 15-29 mL/min: 37.5 mg once daily; GFR <15 mL/min or ESRD: not recommended.
Liver impairment	Child-Pugh A or B: no adjustment; Child-Pugh C: not recommended.
Pediatric use	Not approved for pediatric use; no established pediatric dosing.
Geriatric use	No specific adjustment, but caution due to potential increased sensitivity; monitor for adverse effects.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for SUNOSI (SUNOSI).

Breastfeeding

Teratogenic Risk

Warnings & precautions

■ FDA Black Box Warning

None

Side Effect Profile

Serious Effects

Absolute Contraindications

["Concomitant use of monoamine oxidase inhibitors (MAOIs) or within 14 days of MAOI use","Uncontrolled hypertension or tachyarrhythmias","History of seizure disorder"]