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Selective MAO-B inhibitor + glutamate modulation Pregnancy: Safinamide is not recommended during pregnancy or in women of childbearing potential not using contraception — there are no or limited data in pregnant women and animal studies have shown reproductive toxicity. Safinamide should not be given to women of childbearing potential unless adequate contraception is practised, and should not be used during breast-feeding.

Safinamide

Brand names: Xadago

Safinamide is a selective, reversible monoamine oxidase-B (MAO-B) inhibitor used as an add-on to levodopa in mid-to-late-stage Parkinson's disease with motor fluctuations.

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: Start at 50 mg per day; the daily dose may be increased to 100 mg/day on the basis of individual clinical need
Route: Oral — taken with water, with or without food
Frequency: Once daily
Max: 100 mg/day
If a dose is missed, the next dose should be taken at the usual time the next day. Elderly: no change in dose is required; experience in patients over 75 years of age is limited. Hepatic impairment: no dose adjustment in mild impairment; the lower dose of 50 mg/day is recommended in moderate impairment; use is contraindicated in severe hepatic impairment, and safinamide should be stopped if a patient progresses from moderate to severe impairment. Renal impairment: no change in dose required. At least 7 days must elapse between discontinuation of safinamide and initiation of an MAO inhibitor or pethidine. Safinamide used as an adjunct to levodopa may potentiate levodopa side effects and exacerbate pre-existing dyskinesia, which may require a decrease in the levodopa dose. Paediatric: safety and efficacy in children and adolescents under 18 years of age have not been established — no data are available.

Dose adjustments

Renal

No change in dose is required for patients with renal impairment.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; 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

  • Hypersensitivity to the active substance or to any of the excipients
  • Concomitant treatment with other monoamine oxidase (MAO) inhibitors
  • Concomitant treatment with pethidine
  • Severe hepatic impairment
  • Albinism, retinal degeneration, uveitis, inherited retinopathy or severe progressive diabetic retinopathy

Side effects

  • Dyskinesia — the most common adverse reaction when used in combination with levodopa alone or with other Parkinson's disease treatments (very common)
  • Somnolence, dizziness, headache and worsening of Parkinson's disease (common); paraesthesia, balance disorder, dystonia, dysarthria and syncope (uncommon)
  • Insomnia (common); hallucination, depression, abnormal dreams, anxiety, confusional state, psychotic disorder and restlessness (uncommon)
  • Cataract (common); blurred vision, scotoma, diplopia, photophobia, retinal disorder, conjunctivitis and glaucoma (uncommon)
  • Serious reactions reported with concomitant SSRIs, SNRIs, tricyclic/tetracyclic antidepressants and MAO inhibitors — hypertensive crisis, neuroleptic malignant syndrome, serotonin syndrome and hypotension; also impulse control disorders (pathological gambling, hypersexuality, compulsive spending or buying, binge eating)

Interactions

  • Other MAO inhibitors, including moclobemide — must not be co-administered; risk of non-selective MAO inhibition leading to hypertensive crisis (contraindicated)
  • Pethidine — contraindicated; serious adverse reactions have been reported with concomitant use of pethidine and MAO inhibitors. Allow at least 7 days between stopping safinamide and starting an MAO inhibitor or pethidine
  • SSRIs — may generally be used at the lowest effective dose with caution for serotonergic symptoms; concomitant use with fluoxetine or fluvoxamine should be avoided, or if necessary these should be used at low doses. Consider a washout of 5 half-lives of the previous SSRI before starting safinamide
  • Levodopa — safinamide as an adjunct may potentiate levodopa side effects and exacerbate pre-existing dyskinesia, requiring a levodopa dose decrease
  • BCRP substrates — refer to the SmPC of the co-administered product when safinamide is given with a BCRP substrate

Clinical monograph

How it works

It inhibits MAO-B to increase dopamine availability and additionally modulates glutamate release through state-dependent sodium channel blockade.

Prescribing in practice

  • It should not be combined with other MAO inhibitors, pethidine or potent serotonergic drugs because of the risk of serotonin syndrome and hypertensive reactions.
  • Because of its retinal pharmacology it is contraindicated in patients with severe pre-existing retinal disorders such as retinitis pigmentosa or advanced diabetic retinopathy.
  • As an adjunct to levodopa it may worsen dyskinesia, which can require a reduction in the levodopa dose.

Monitoring

Monitor for dyskinesia, impulse-control disorders, blood pressure changes and, in those with risk factors, ophthalmological status.

Counselling the patient

  • Report any new impulsive or compulsive behaviour, such as gambling or excessive spending.
  • Tell other prescribers you take safinamide before starting antidepressants or certain painkillers.
  • Mention any change in vision to your clinician.

Evidence & guidelines

Safinamide's efficacy as an adjunct to levodopa in fluctuating Parkinson's disease was shown in randomised controlled trials and it is recommended as an option by NICE.

Reference: NICE NG71; 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.

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