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Triptan (5-HT1 agonist) / Antimigraine Pregnancy: UK SPC §4.6 verbatim: 'Post-marketing data from the use of sumatriptan during the first trimester in over 1,000 women are available. Although these data contain insufficient information to draw definitive conclusions, they do not point to an increased risk of congenital defects. Experience with the use of sumatriptan in the second and third trimester is limited. Evaluation of experimental animal studies does not indicate direct teratogenic effects or harmful effects on peri- and postnatal development. However, embryonic and foetal death may occur in rabbits. Administration of sumatriptan should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus.' Breast-feeding, §4.6: 'Sumatriptan is secreted into breast milk, with average relative infant doses of 4% following administration of a single dose of sumatriptan. Infant exposure can be minimised by avoiding breast feeding for 12 hours after treatment, during which time any breast milk expressed should be discarded. There have been reports of breast pain and/or nipple pain following sumatriptan use in breast-feeding women. The pain was usually transient and disappeared in 3 to 12 hours.' US label §8.1 adds that 'Data from a prospective pregnancy exposure registry and epidemiological studies of pregnant women have not detected an increased frequency of birth defects or a consistent pattern of birth defects among women exposed to sumatriptan compared with the general population', while 'In developmental toxicity studies in rats and rabbits, oral administration of sumatriptan to pregnant animals was associated with embryolethality, fetal abnormalities, and pup mortality.'

Sumatriptan

Brand names: Imigran, Migraitan

Used in: Headache & Migraine

Sumatriptan is a triptan used for acute migraine and cluster headache; it is for treating attacks, not for prevention.

Adult dose

Dose: 50 mg (one tablet) as a single dose, taken as early as possible after the onset of a migraine attack; some patients may require 25 mg or 100 mg
Route: Oral - §4.2: 'The tablets should be swallowed whole with water.'
Frequency: One dose per attack. §4.2: 'If the patient has responded to the first dose but the symptoms recur a second dose may be given provided that there is a minimum interval of two hours between the two doses.'
Max: Maximum 300 mg oral in any 24-hour period - §4.2: 'No more than 300 mg should be taken in any 24-hour period.'
SCOPE - THIS RECORD COVERS THE ORAL ROUTE ONLY, which is this page's primary route. Showing an injection ceiling beside an oral one on the same card is exactly the defect an earlier adversarial-verify pass held this record for; source the UK SPC for each additional route separately before adding it. || §4.2 verbatim: 'Sumatriptan is indicated for the acute intermittent treatment of migraine. It should not be used prophylactically. The recommended dose of sumatriptan should not be exceeded. It is advisable that sumatriptan be given as early as possible after the onset of a migraine attack, but it is equally effective at whatever stage of the attack it is administered. The recommended dose of oral sumatriptan is a 50 mg tablet. Some patients may require 25 mg or 100 mg.' || §4.2: 'The tablet cannot be divided into two equal doses; if necessary, the use of other medicinal product with the same active ingredient, dosage and pharmaceutical form available in divisible tablet should be considered.' || NON-RESPONSE, §4.2: 'Patients who do not respond to the prescribed dose of sumatriptan should not take a second dose for the same attack. In these cases, the attack can be treated with paracetamol, acetylsalicylic acid or non-steroidal anti-inflammatory drugs. Sumatriptan may be taken for subsequent attacks.' || §4.2: 'Sumatriptan is recommended as monotherapy for the acute treatment of migraine and should not be given concomitantly with ergotamine or derivatives of ergotamine (including methysergide).' || ELDERLY, §4.2: 'Experience of the use of sumatriptan in patients aged over 65 years is limited. The pharmacokinetics do not differ significantly from a younger population but until further clinical data are available, the use of sumatriptan in patients aged over 65 years is not recommended.' || PAEDIATRIC, §4.2: 'The efficacy and safety of sumatriptan film-coated tablets in children aged less than 10 years have not been established. No clinical data are available in this age group. The efficacy and safety of sumatriptan film-coated tablets in children 10 to 17 years of age have not been demonstrated in the clinical trials performed in this age group. Therefore, the use of sumatriptan film-coated tablets in children 10 to 17 years of age is not recommended.' The US label §8.4 adds that five controlled trials of oral sumatriptan in patients aged 12 to 17 years 'did not establish the efficacy of oral sumatriptan compared with placebo in the treatment of migraine in pediatric patients', and that two controlled trials of the nasal spray in that age group likewise did not establish efficacy. paedDose is therefore null. || DIAGNOSIS, §4.4: 'Sumatriptan should only be used where there is a clear diagnosis of migraine. Sumatriptan is not indicated for use in the management of hemiplegic, basilar or opthalmoplegic migraine.'

Dose adjustments

Renal

No renal dose adjustment is stated in the UK SPC. §4.4: 'Sumatriptan should be administered with caution to patients with conditions which may affect significantly the absorption, metabolism or excretion of drugs, e.g. impaired hepatic (see section 5.2) or renal function (see section 5.2).' Some sections of the product information we used were incomplete — check the full SPC.

Hepatic

UK SPC §4.2, Hepatic impairment, in full: 'Dosage adjustment is necessary in these patients (see sections 4.4 and 5.2).' §4.3 contraindicates sumatriptan outright in SEVERE hepatic impairment ('Sumatriptan should not be administered to patients with severe hepatic impairment'), and the US injection label likewise lists severe hepatic impairment among its contraindications.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

US labelling (FDA)

Reference — US labelling, may differ from UK

• For subcutaneous use only (2.1) • Acute treatment of migraine: single dose of 1 to 6 mg (2.1) • Acute treatment of cluster headache: single dose of 6 mg (2.1) • Maximum dose in a 24-hour period: 12 mg, separate doses by at least 1 hour (2.1) • Patients receiving doses other than 4 or 6 mg: Use the 6-mg single-dose vial (2.3) 2.1 Dosing Information The maximum single recommended adult dose of Sumatriptan injection, USP for the acute treatment of migraine or cluster headache is 6 mg injected subcutaneously. For the treatment of migraine, if side effects are dose limiting, lower doses (1 mg to 5 mg) may be used [see Clinical Studies (14.1)]. For the treatment of cluster headache, the …

Source: US FDA prescribing information (openFDA / DailyMed), label dated 2024-09-28. Accessed 2026-06-12. US dosing and indications can differ from UK practice — use UK sources for prescribing decisions.

Contraindications

  • UK SPC §4.3: 'Hypersensitivity to the active substance or to any of the excipients listed in section 6.'
  • UK SPC §4.3: 'Sumatriptan should not be given to patients who have had myocardial infarction or have ischaemic heart disease, coronary vasospasm (Prinzmetal's angina), peripheral vascular disease or patients who have symptoms or signs consistent with ischaemic heart disease.'
  • UK SPC §4.3: 'Sumatriptan should not be administered to patients with a history of cerebrovascular accident (CVA) or transient ischaemic attack (TIA).'
  • UK SPC §4.3: 'Sumatriptan should not be administered to patients with severe hepatic impairment.'
  • UK SPC §4.3: 'The use of sumatriptan in patients with moderate and severe hypertension and mild uncontrolled hypertension is contraindicated.'
  • UK SPC §4.3: 'Concurrent administration of reversible and irreversible monoamine oxidase inhibitors and sumatriptan is contraindicated. Sumatriptan tablets must not be used within two weeks of discontinuation of therapy with monoamine oxidase inhibitors.'
  • UK SPC §4.3: 'The concomitant administration of ergotamine or derivatives of ergotamine (including methysergide) or any triptan/5-hydroxytryptamine 1 (5-HT 1 ) receptor agonist or lithium with sumatriptan is contraindicated.'
  • Listed additionally on the US SUBCUTANEOUS-INJECTION label §4 (a different product and route from the oral dose above, recorded here as a safety cross-check): Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders; history of hemiplegic or basilar migraine; ischemic bowel disease; uncontrolled hypertension; recent use (within 24 hours) of an ergotamine-containing or ergot-type medication or another 5-HT1 agonist; hypersensitivity to sumatriptan (angioedema and anaphylaxis seen)

Side effects

  • Common (UK §4.8): dizziness, somnolence, sensory disturbance including paraesthesia and hypoaesthesia
  • Common: transient increases in blood pressure arising soon after treatment; flushing
  • Common: dyspnoea
  • Common: nausea and vomiting - §4.8 notes 'it is unclear if this is related to sumatriptan or the underlying condition'
  • Common: 'Sensations of heaviness (usually transient and may be intense and can affect any part of the body including the chest and throat)'; myalgia
  • Common: 'Pain, sensations of heat or cold, pressure or tightness (these events are usually transient and may be intense and can affect any part of the body including the chest and throat); feelings of weakness, fatigue'
  • Rare: breast pain. Very rare: 'Minor disturbances in liver function tests have occasionally been observed.'
  • Not known: hypersensitivity reactions ranging from cutaneous hypersensitivity (such as urticaria) to anaphylactic reactions; anxiety; hyperhidrosis
  • Not known: 'Seizures, although some have occurred in patients with either a history of seizures or concurrent conditions predisposing to seizures. There are also reports in patients where no such predisposing factors are apparent.' Tremor, dystonia, nystagmus, visual field defect
  • Not known (eye): 'Flickering, diplopia, reduced vision. Loss of vision including reports of permanent defects. However, visual impairment may also occur during a migraine attack itself.'
  • Not known (cardiac): 'Bradycardia, tachycardia, palpitations, cardiac arrhythmias, transient ischaemic ECG changes, coronary artery vasospasm, angina pectoris, myocardial infarction'; hypotension, Raynaud's phenomenon
  • Not known (GI): ischaemic colitis, diarrhoea, dysphagia. Not known (musculoskeletal): neck stiffness, arthralgia
  • UK §4.4: 'Following administration, sumatriptan can be associated with transient symptoms including chest pain and tightness, which may be intense and involve the throat. Where such symptoms are thought to indicate ischaemic heart disease, no further doses of sumatriptan should be given and appropriate evaluation should be carried out.'
  • Serotonin syndrome, UK §4.4: 'There have been rare post-marketing reports describing patients with serotonin syndrome (including altered mental status, autonomic instability and neuromuscular abnormalities) following the use of a selective serotonin reuptake inhibitor (SSRI) and sumatriptan. Serotonin syndrome has been reported following concomitant treatment with triptans and serotonin noradrenaline reuptake inhibitors (SNRIs).'

Monitoring

  • UK SPC §4.4: 'Before treating with sumatriptan, care should be taken to exclude potentially serious neurological conditions, e.g. cerebrovascular accident (CVA), transient ischaemic attack (TIA), if the patient presents with atypical symptoms or if they have not received an appropriate diagnosis for sumatriptan use.'
  • UK SPC §4.4: 'Sumatriptan should not be given to patients with risk factors for ischaemic heart disease, including those patients who are diabetics, heavy smokers or users of nicotine substitution therapies, without prior cardiovascular evaluation. Special consideration should be given to postmenopausal women and males over 40 with these risk factors.'
  • UK SPC §4.4: where chest pain or tightness is thought to indicate ischaemic heart disease, 'no further doses of sumatriptan should be given and appropriate evaluation should be carried out'
  • Blood pressure - UK SPC §4.4: 'Sumatriptan should be administered with caution to patients with mild controlled hypertension, since transient increases in blood pressure and peripheral vascular resistance have been observed in a small proportion of patients.' Transient increases in blood pressure soon after treatment are a COMMON adverse reaction (§4.8).
  • UK SPC §4.4: 'If concomitant treatment with sumatriptan and an SSRI/SNRI is clinically warranted, appropriate observation of the patient is advised.'
  • US injection label §5.6 (safety cross-check): 'Medication overuse headache: Detoxification may be necessary.' US §8.5: 'A cardiovascular evaluation is recommended for geriatric patients who have other cardiovascular risk factors (e.g., diabetes, hypertension, smoking, obesity, strong family history of CAD) prior to receiving sumatriptan.'

Clinical monograph

How it works

It is a 5-HT1B/1D receptor agonist that constricts cranial blood vessels and inhibits release of pro-inflammatory neuropeptides.

Prescribing in practice

  • It is contraindicated in ischaemic heart disease, previous myocardial infarction, uncontrolled hypertension and cerebrovascular disease, because of vasoconstriction.
  • Take it early in the headache phase; overuse can cause medication-overuse headache.
  • Use caution with other serotonergic drugs.

Monitoring

Review attack frequency and response, and watch for medication-overuse headache.

Counselling the patient

  • Take it as soon as the migraine headache (not the aura) begins.
  • Do not exceed the recommended number of doses in a day or month.
  • Report chest tightness or pain.

Evidence & guidelines

A first-line acute migraine treatment, often combined with an NSAID or antiemetic, per NICE CG150.

Reference: NICE NG150 Headaches; SIGN 155 Migraine; 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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