Nuvigil
Nuvigil
Generic Name
Nuvigil
Mechanism
- Selective dopamine reuptake inhibition:
- Increases extracellular dopamine levels, particularly in the locus coeruleus and basal forebrain.
- Modulation of norepinephrine:
- Amplifies catecholaminergic tone, enhancing vigilance.
- Indirect orexin facilitation:
- Through dopaminergic pathways, it augments orexin (hypocretin) signaling, a key regulator of wakefulness.
Result: A balanced stimulant effect that improves wakefulness without the broader CNS activation seen with methylphenidate.
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Pharmacokinetics
| Parameter | Detail | |
| Absorption | Rapid; Tmax ≈ 2–4 h post‑dose; ~80 % bioavailability (food reduces Cmax by 70 % unchanged; urinary half‑life ~10–11 h. | |
| Half‑life | 5–7 h (steady‑state ~6 h). | |
| Drug interactions | Mild with CYP inhibitors/inducers (no major interactions). |
> Note – Dose adjustment recommended for moderate hepatic impairment (UI ≤ 5 L). No adjustment in mild renal impairment.
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Indications
- Narcolepsy with EDS (both adults and adolescents ≥ 12 y).
- OSA‑related EDS as adjunct to CPAP or other therapies.
*Not indicated* for cataplexy, REM sleep behavior disorder, or drug‑induced EDS.
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Contraindications
- Contraindications
- Hypersensitivity to solriamfetol or any excipient.
- Warnings / Precautions
- Cardiovascular: use cautiously in uncontrolled hypertension, ischemic heart disease, or arrhythmias; can raise BP/HR.
- Psychiatric: monitor for onset or exacerbation of mania, depression, or anxiety; screen for suicidal ideation.
- Pregnancy: Category N; avoid if possible.
- Drug‑Safety: not for patients with known stimulant abuse; has mild abuse potential.
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Dosing
| Population | Initial Dose | Titration | Max Dose | Formulation |
| Adults (≥ 18 y) | 150 mg PO once daily (morning) | Increase by 150 mg at week 2 if tolerated | 300 mg once daily (or 150 mg BID) | 150 mg and 300 mg tablets |
| Children ≥ 12 y (off‑label) | 75 mg PO daily | Increase to 150 mg as needed | 150 mg daily | – |
• Split dosing (75 mg AM + 75 mg PM) can reduce GI side effects.
• Missed dose: take as soon as remembered; skip if close to next dose.
• Refill: do not exceed 4 weeks without provider review.
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Adverse Effects
- Common (≥ 10 % incidence)
- Headache
- Nausea / vomiting
- Decreased appetite
- Insomnia / restlessness
- Dry mouth
- Elevated systolic/diastolic blood pressure
- Serious (≤ 1 % incidence)
- Severe hypertension / tachycardia
- Preeclampsia‑like syndrome (rare)
- Psychiatric events (mania, psychosis)
- Suicidal ideation / behavior
- Orthostatic hypotension with reflex tachycardia
> Monitoring: severe side effects are usually dose‑related and often resolve with dose adjustment or discontinuation.
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Monitoring
- Baseline:
- Blood pressure, heart rate, fasting glucose, basic metabolic panel, ECG (if cardiac history).
- On‑therapy:
- BP & HR at each visit (≥ monthly initially).
- Weight and appetite changes.
- Mood and suicidality screening.
- Renal function if dose adjusted or liver impairment present.
- Special populations:
- Re‑evaluate dosing in women trying to conceive.
- Consider close titration in adolescents with a history of psychiatric illness.
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Clinical Pearls
- Selective dopamine release but minimal norepinephrine re‑uptake → less jitteriness than methylphenidate.
- No Schedule‑II status: lower regulatory risk for inpatient use (e.g., ICU delirium management).
- Adjunctive potential: can be paired with CPAP or modafinil—monitor cumulative cardiovascular load.
- Food effect: only mild; patients can take with or without food.
- Splitting the dose mitigates GI upset and can provide smoother wakefulness.
- Use with caution in patients on monoamine oxidase inhibitors: theoretical risk of hypertensive reaction.
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