Neuroprotective Agent — ALS/Motor Neurone Disease Pregnancy: Contraindicated in pregnancy and in breast-feeding (§4.3). Clinical experience in pregnant women is lacking; it is not known whether riluzole is excreted in human milk.

Riluzole

Brand names: Rilutek, Teglutik (oral suspension)

Riluzole is a glutamate-modulating agent and is the principal disease-modifying drug licensed for amyotrophic lateral sclerosis (motor neurone disease).

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: 100 mg daily (50 mg every 12 hours)

Route: Oral

Frequency: Every 12 hours (twice daily)

The recommended daily dose in adults or elderly is 100 mg (50 mg every 12 hours). No significant increased benefit can be expected from higher daily doses (the SPC does not state a separate maximum dose). Treatment should only be initiated by specialist physicians with experience in the management of motor neurone diseases. Elderly: based on pharmacokinetic data there are no special instructions. Renal impairment: not recommended (repeated-dose studies have not been conducted in this population). Hepatic: contraindicated in hepatic disease or baseline transaminases greater than 3 times the upper limit of normal. Monitoring: serum transaminases including ALT should be measured before and during therapy because of the risk of hepatitis — monthly during the first 3 months, every 3 months for the remainder of the first year, and periodically thereafter; discontinue riluzole if ALT increases to 5 times the ULN (re-administration in this situation cannot be recommended). Patients should report any febrile illness — check white cell count and discontinue if neutropenia. Paediatric: not recommended for use in children, due to a lack of data on safety and efficacy in any neurodegenerative disease occurring in children or adolescents.

Dose adjustments

Renal

Not recommended for use in patients with impaired renal function, as studies at repeated doses have not been conducted in this population.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC — 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
Hepatic disease or baseline transaminases greater than 3 times the upper limit of normal
Patients who are pregnant or breast-feeding

Side effects

Asthenia (very common)
Nausea (very common); diarrhoea, abdominal pain and vomiting (common)
Abnormal liver function tests (very common); hepatitis (uncommon)
Headache, dizziness, oral paraesthesia and somnolence (common); tachycardia (common)
Severe neutropenia (uncommon) and interstitial lung disease (uncommon) — both require immediate review/discontinuation

Interactions

No clinical studies have been performed to evaluate interactions of riluzole with other medicinal products (SPC §4.5)
CYP1A2 is the principal isozyme involved in the initial oxidative metabolism of riluzole (in vitro human liver microsome data)
Inhibitors of CYP1A2 (e.g. caffeine, diclofenac, diazepam, nicergoline, clomipramine, imipramine, fluvoxamine, phenacetin, theophylline, amitriptyline and quinolones) could potentially decrease the rate of riluzole elimination
Inducers of CYP1A2 (e.g. cigarette smoke, charcoal-broiled food, rifampicin and omeprazole) could increase the rate of riluzole elimination

Clinical monograph

How it works

It is thought to act by inhibiting glutamate release and stabilising voltage-dependent sodium channels, reducing glutamate-mediated excitotoxicity of motor neurones.

Prescribing in practice

It can cause hepatotoxicity and dose-dependent rises in transaminases, so liver function must be checked before and regularly during treatment and the drug stopped if enzymes rise markedly.
Neutropenia has been reported, and any febrile illness should prompt a full blood count.
It modestly prolongs survival rather than improving symptoms, and expectations should be set accordingly.

Monitoring

Monitor liver transaminases before treatment and periodically thereafter, and check a full blood count if the patient develops a febrile illness.

Counselling the patient

Report any fever, sore throat or other signs of infection promptly so that blood counts can be checked.
Report symptoms of liver problems such as jaundice, dark urine or unexplained nausea.
The medicine aims to slow disease progression rather than relieve existing symptoms.

Evidence & guidelines

Riluzole was shown to prolong survival in amyotrophic lateral sclerosis in landmark randomised controlled trials and is recommended by NICE for this indication.

Reference: NICE TA20 (Riluzole in ALS); Motor Neurone Disease Association (MNDA) Guidelines; 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).

Curated clinical cross-links plus same-class fallbacks.

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