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Dopamine-noradrenaline reuptake inhibitor Pregnancy: US label section 8.1: available data from case reports are not sufficient to determine drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, oral administration during organogenesis caused maternal and fetal toxicities in rats and rabbits and was teratogenic. A pregnancy exposure registry exists.

Solriamfetol

Brand names: Sunosi

Solriamfetol is a wakefulness-promoting agent used to improve wakefulness in adults with excessive daytime sleepiness due to narcolepsy or obstructive sleep apnoea.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Narcolepsy: 75 mg once daily initially (recommended range 75 mg to 150 mg once daily). Obstructive sleep apnoea: 37.5 mg once daily initially (recommended range 37.5 mg to 150 mg once daily)
Route: Oral
Frequency: Once daily upon awakening, with or without food; avoid taking within 9 hours of planned bedtime
Max: 150 mg once daily
SOURCE CAVEAT: no UK SPC was retrieved in this bundle. Dose is from the US FDA prescribing information for SUNOSI (Axsome Therapeutics) sections 2.2 to 2.4 — verify against the UK SPC. Based on efficacy and tolerability the dosage may be doubled at intervals of at least 3 days. Dosages above 150 mg daily do not confer increased effectiveness sufficient to outweigh dose-related adverse reactions. Ensure blood pressure is adequately controlled before initiating treatment (section 2.1), and measure heart rate and blood pressure before starting and periodically during treatment. The 75 mg tablets are functionally scored and can be split in half to give 37.5 mg. Paediatrics: section 8.4 states that safety and effectiveness in paediatric patients have not been established and that clinical studies in paediatric patients have not been conducted — verify any paediatric use against a children's formulary. Elderly: solriamfetol is predominantly eliminated by the kidney, so dosing may need adjustment based on eGFR; consider lower doses and close monitoring (section 8.5).

Dose adjustments

Renal

US label section 2.5. Moderate renal impairment (eGFR 30-59 mL/min/1.73 m2): initiate at 37.5 mg once daily; dose may be increased to a maximum of 75 mg once daily after at least 7 days. Severe renal impairment (eGFR 15-29 mL/min/1.73 m2): 37.5 mg once daily, and the maximum recommended daily dose is 37.5 mg. End stage renal disease (eGFR below 15 mL/min/1.73 m2): not recommended.

Dose auto-extracted from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days, because of the risk of hypertensive reaction

Side effects

  • Headache (most common adverse reactions, incidence at least 5% and greater than placebo)
  • Nausea
  • Decreased appetite
  • Insomnia
  • Anxiety
  • Dose-dependent increases in systolic and diastolic blood pressure and heart rate

Interactions

  • Monoamine oxidase inhibitors — do not administer concomitantly or within 14 days after discontinuing MAOI treatment; concomitant use of MAOIs and noradrenergic drugs may increase the risk of a hypertensive reaction (section 7.1)
  • Other drugs that increase blood pressure and/or heart rate — combination not evaluated; use with caution (section 7.2)
  • Dopaminergic drugs (those that increase dopamine levels or bind directly to dopamine receptors) — potential pharmacodynamic interactions; use caution (section 7.3)

Clinical monograph

How it works

It is a dopamine and noradrenaline reuptake inhibitor, increasing synaptic levels of these neurotransmitters to promote wakefulness.

Prescribing in practice

  • It can raise blood pressure and heart rate, so it is contraindicated with concurrent monoamine oxidase inhibitors and used with caution in those with cardiovascular disease, with blood pressure reviewed before and during treatment.
  • In obstructive sleep apnoea it treats residual sleepiness only and does not replace primary therapies such as continuous positive airway pressure.
  • The dose should be reduced in renal impairment and it is not recommended in end-stage renal disease.

Monitoring

Monitor blood pressure and heart rate before and periodically during treatment, and review the degree of daytime sleepiness.

Counselling the patient

  • Take the dose on waking and avoid taking it within several hours of bedtime to prevent difficulty sleeping.
  • Continue your underlying sleep apnoea therapy, such as CPAP, as this medicine does not replace it.
  • Report palpitations, chest pain or breathlessness, and attend blood pressure checks.

Evidence & guidelines

Solriamfetol improved wakefulness in narcolepsy and obstructive sleep apnoea in the randomised TONES trials and is licensed for these indications.

Reference: NICE TA758; SmPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.