Class: Selective Serotonin Agonists
VA Class: CN105
Chemical Name: C14H21N3O2S
Molecular Formula: C14H21N3O2S•C4H6O4
CAS Number: 103628-46-2
Brands: Alsuma, Imitrex, Sumavel, Treximet
Uses for Sumatriptan Succinate
Sumatriptan Succinate Dosage and Administration
Administer sumatriptan tablets orally with fluids; swallow tablet whole.148
Administer sumatriptan/naproxen fixed-combination tablets with or without food; do not split, crush, or chew.281
Administer intranasally as a single spray into 1 nostril.249
Nasal solution unit contains only 1 spray; do not test before use.249
To administer, remove unit from package just before use.249 While sitting down, gently blow nose to clear nasal passages.249 Keep head in upright position and gently close 1 nostril with index finger; exhale gently through mouth.249 With other hand, hold unit with thumb supporting at bottom and index and middle fingers on either side of nozzle.249 Insert nozzle into open nostril about ½ inch.249 While gently inhaling through nose (with closed mouth), release spray by firmly pressing plunger.249 Remove nozzle from nostril while keeping head level for 10–20 seconds and gently inhaling through nose and exhaling through mouth; do not inhale deeply.249 Consult administration instructions provided by manufacturer before use.249
Injection pen for use with prefilled cartridges (each containing a 4- or 6-mg dose): Needle penetrates approximately 5–6 mm (¼ inch); use injection sites with an adequate skin and subcutaneous thickness to accommodate needle length (e.g., lateral thigh, upper arm).1 284
Prefilled injection pen (containing 6-mg dose): Needle projects ¼ inch following activation of device; use injection sites with an adequate skin and subcutaneous thickness to accommodate needle length (e.g., lateral thigh, upper arm).279
Prefilled needleless injection device (containing 6-mg dose): Use administration sites on abdomen (avoiding 2-inch area around the umbilicus) or thigh with an adequate subcutaneous thickness to accommodate penetration of the solution into the subcutaneous space.280 Avoid using administration sites on upper arm, since delivered dose may be suboptimal.280
In patients receiving doses other than 4 or 6 mg, only the single-dose vials containing 6 mg/0.5 mL should be used to provide the desired dose.1
25, 50, or 100 mg as a single dose.148 Individualize dosage selection, weighing the possible benefit (greater effectiveness) and risks (increased adverse effects) of the 50- or 100-mg dose; 100-mg dose may not provide substantially greater effect than 50-mg dose.148
If headache recurs or partial response occurs after initial dose, additional oral doses may be administered at intervals of ≥2 hours, up to a maximum oral dosage of 200 mg daily.148
If headache recurs after an initial sub-Q dose, additional oral doses may be administered at intervals ≥2 hours, up to a maximum oral dosage of 100 mg daily.148Oral (Sumatriptan/Naproxen)
Sumatriptan 85 mg (with naproxen sodium 500 mg) as a single dose.281
5, 10, or 20 mg as a single dose; individualize dosage selection, weighing the possible benefit (greater effectiveness) and risks (increased adverse effects) of the 20-mg dose.249 Doses >20 mg provide no additional benefit.249
To achieve a 10-mg dose, administer a single 5-mg dose into each nostril.249
If headache recurs, dose may be repeated once after 2 hours, up to a maximum dosage of 40 mg daily.249Sub-Q
≤6 mg as a single dose.1 If dose-limiting adverse effects occur with 6-mg dose, lower doses (e.g., 1–5 mg) may be given.
If headache recurs, 6-mg dose may be repeated once after ≥1 hour, up to a maximum dosage of 12 mg in any 24-hour period.1
Maximum 200 mg daily; do not exceed 100 mg daily if following an initial sub-Q dose.148
Safety of treating an average of >4 headaches per 30-day period has not been established.148Oral (Sumatriptan/Naproxen)
Maximum 2 doses (total sumatriptan dosage of 170 mg) in any 24-hour period.281
Safety of treating an average of >5 headaches per 30-day period has not been established.281Intranasal
Maximum 40 mg daily.249
Safety of treating an average of >4 headaches per 30-day period has not been established.249Sub-Q
Maximum 6 mg as a single dose; do not exceed 12 mg (i.e., two 6-mg doses given ≥1 hour apart) in any 24-hour period.1
Maximum 6 mg as a single dose; do not exceed 12 mg (i.e., two 6-mg doses given ≥1 hour apart) in any 24-hour period.1
Unpredictable increases in bioavailability following oral administration in patients with hepatic impairment.148 If oral therapy is deemed advisable in these patients, do not exceed 50 mg as a single dose.148 Avoid use of fixed-combination tablets containing sumatriptan 85 mg and naproxen sodium 500 mg, since sumatriptan dosage cannot be appropriately adjusted.281
Select dosage with caution, usually starting at the low end of the dosage range.1
Cautions for Sumatriptan Succinate
Wolff-Parkinson-White syndrome or cardiac arrhythmias associated with other accessory pathway conduction disorders.1
Careful Diagnosis of Migraine
Use oral or intranasal sumatriptan only in patients in whom a clear diagnosis of migraine has been established.148 249 Use sub-Q sumatriptan only in patients in whom a clear diagnosis of migraine or cluster headache has been established.1
If first migraine attack treated with sumatriptan fails to respond to the drug, reconsider diagnosis before administering sumatriptan to treat subsequent attacks.1
Exclude other potentially serious neurologic disorders before administering sumatriptan to patients not previously diagnosed with migraine or cluster headache or to those with atypical symptoms.1 61 148 236 237 249
Possible myocardial ischemia and/or infarction and coronary vasospasm, even in patients without a history of CAD.1 148 249 Contraindicated in patients with ischemic or vasospastic heart disease.1 148 249
Contraindicated in patients with Wolff-Parkinson-White syndrome or cardiac arrhythmias associated with other accessory pathway conduction disorders.1
Tightness, pain, pressure, and heaviness in the precordium, throat, neck, and jaw occur frequently but usually are noncardiac in origin.1 148 249 Manufacturer states that cardiovascular evaluation should be performed if patient is at high cardiac risk.1
Patients with symptoms suggestive of angina after receiving sumatriptan should be evaluated for presence of CAD or predisposition to Prinzmetal variant angina before receiving additional doses;1 148 249 if administration resumed and such signs or symptoms recur, ECG evaluation recommended.148 249
Patients at Risk for CAD
Perform cardiovascular evaluation prior to initiating therapy in patients with multiple cardiovascular risk factors (e.g., postmenopausal women; men >40 years of age; patients with risk factors such as hypertension, hypercholesterolemia, smoking, obesity, diabetes, family history of CAD) who have not previously received 5-HT1 receptor agonist therapy.1 34 148 164 249
Other Vasospastic Effects
Possible noncoronary vasospastic reactions (e.g., peripheral vascular ischemia, GI ischemia and infarction with abdominal pain and bloody diarrhea, splenic infarction, Raynaud’s syndrome); transient or permanent blindness and partial vision loss reported very rarely in patients receiving 5-HT1 receptor agonists.1 148 249
Monitor BP in all patients receiving the drug.1
Potentially life-threatening serotonin syndrome reported in patients receiving 5-HT1 receptor agonists, particularly in those receiving SSRIs or SNRIs concomitantly.1 148 249 272 (See Specific Drugs under Interactions.) Also may occur in patients receiving MAO inhibitors or tricyclic antidepressants concomitantly.1
Symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile BP, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination), and/or GI symptoms (e.g., nausea, vomiting, diarrhea).1 148 249 272
Medication Overuse Headache
Overuse of drugs indicated for management of acute migraine attacks (e.g., use of 5-HT1 receptor agonists, ergotamine, opiates, or certain analgesic combinations on a regular basis for ≥10 days per month) may result in migraine-like daily headaches or a marked increase in frequency of migraine attacks.1 148 249 276 277
Detoxification, including withdrawal of overused drugs; treatment of withdrawal symptoms (e.g., transient worsening of headaches); and consideration of prophylactic migraine therapy may be necessary.1 148 249 276 277
Possible transient irritation in nose and throat (e.g., burning, numbness, paresthesia, discharge, pain/soreness), sometimes severe, after intranasal administration; symptoms usually resolve in <2 hours.249 Effects of extended and repeated use on nasal and/or respiratory mucosa not systematically evaluated.249
Hypersensitivity reactions (e.g., anaphylaxis/anaphylactoid reactions), possibly life-threatening or fatal, reported rarely; increased risk in patients with history of sensitivity to multiple allergens.1 148 249
Use of Fixed Combinations
When used in fixed combination with naproxen, consider the cautions, precautions, and contraindications associated with naproxen.281
Distributed into human milk.14 40 148 242 249 279 280 283 Caution advised if sumatriptan is used.279 280 Expressing and discarding all milk for 8 hours after receiving a sub-Q dose may minimize exposure to the limited amount of drug distributed into milk.242 283 The manufacturers recommend avoiding breast-feeding for 12 hours after receiving sumatriptan oral tablets or nasal spray.148 249
Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.1
Due to important role of the liver in presystemic clearance of oral sumatriptan, dosage adjustment recommended if oral therapy is deemed advisable in patients with hepatic impairment.148 (See Hepatic Impairment under Dosage and Administration.)
Pharmacokinetics of sub-Q sumatriptan not substantially altered in patients with moderate hepatic impairment.1
Common Adverse Effects
With oral therapy, pain/pressure sensations in chest/neck/throat/jaw, paresthesia, warm or cold sensation, malaise/fatigue, vertigo.148
With intranasal therapy, taste disturbances, nausea, vomiting, disorder/discomfort of nasal cavity or sinuses.249
With sub-Q therapy, injection site reaction; atypical sensations (e.g., tingling, warm/hot sensation, burning, feeling of heaviness, pressure, tightness, numbness, paresthesia); dizziness/vertigo; flushing; discomfort of throat, jaw, sinuses, or nasal cavity; weakness, neck pain/stiffness, myalgia; drowsiness/sedation; headache; sweating; chest discomfort (tightness, pressure); nausea and vomiting.1
Interactions for Sumatriptan Succinate
Metabolized principally by MAO-A isoenzyme in vitro.148
Pretreatment with oral sumatriptan followed by acetaminophen affected rate, but not extent of acetaminophen absorption over 8 hours187
Antidepressants, SSRIs (e.g., citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline) and SNRIs (e.g., duloxetine, venlafaxine)
Observe carefully if used concomitantly, particularly during treatment initiation, dosage increases, or when another serotonergic agent is initiated272
Ergot alkaloids (e.g., ergotamine, dihydroergotamine, methysergide [no longer commercially available in the US])
Topical application of xylometazoline to nasal mucosa 15 minutes prior to intranasal sumatriptan did not affect sumatriptan pharmacokinetics249
Sumatriptan Succinate Pharmacokinetics
Absorbed rapidly after oral, intranasal, or sub-Q administration, with peak plasma concentrations attained within approximately 0.5–5 hours, 0.8–1.8 hours, or 5–20 minutes, respectively.1 2 3 13 45 61 78 79 89 96 123 146 148 166 168 236 280
Bioavailability after sub-Q administration averages 97% of that obtained with IV administration;1 44 bioavailability after oral or intranasal administration averages only about 15 or 17%, respectively, principally due to presystemic metabolism and in part due to incomplete absorption.2 13 14 44 45 61 89 146 148 166 168 249
Oral absorption is not appreciably affected by gastric stasis that may occur during migraine attack,3 13 45 146 but time to peak concentration is prolonged by about 30 minutes;3 13 45 96 146 148 pharmacokinetics after sub-Q injection or after oral administration in fixed combination with naproxen sodium appear to be similar during migraine attacks and pain-free periods.1 281
Oral administration of sumatriptan 85 mg/naproxen sodium 500 mg (as fixed combination) or sumatriptan 100 mg alone resulted in similar peak concentrations and AUCs of sumatriptan; time to peak concentration was about 30 minutes shorter when administered as the fixed combination.281
Following sub-Q administration via needleless device at sites on the abdomen or thigh, peak concentrations and time to peak concentrations were similar; administration using this technique at sites on the upper arm may result in delivery of a suboptimal dose.280
In patients with hepatic impairment, bioavailability after oral administration may be markedly increased.148 In a small study, AUC and peak plasma concentrations increased approximately 70% and time to peak plasma concentrations occurred 40 minutes earlier after oral administration compared with such values in healthy adults.13 44 148 236
After oral administration, onset of relief of migraine symptoms generally occurs within 1–3 hours after single doses (25–100 mg),92 148 162 178 191 with maximum pain relief attained within 3–6 hours.148 178 191
After sub-Q administration, onset of pain relief usually occurs within 10–34 minutes in patients with moderate to severe migraine headache pain, with maximum relief attained within 1–2 hours;1 8 9 13 47 56 162 176 181 onset of pain relief generally occurs within 4–7 minutes in patients with cluster headache, with headache resolution shortly thereafter.40 49 75 184
Plasma Protein Binding
Metabolized in the liver and possibly in the GI tract principally to inactive indole acetic acid metabolite and other minor metabolites;1 2 3 13 14 104 148 166 metabolized principally by MAO-A isoenzyme in vitro.1 37 48 148
After oral administration, excreted in urine (57–60%) and feces (37–40%); only 3 and 9% of dose is excreted as unchanged drug in urine and feces, respectively.14 45 148 13 45 148 166 168 After sub-Q administration, approximately 22 or 38–53% of dose is excreted in urine unchanged or as indole acetic acid metabolite, respectively;1 45 168 0.6 and 3.3% of dose is excreted in feces as unchanged drug and indole acetic acid metabolite, respectively.2 13 14 45
2–30°C; protect from light.249
Cartridge, vial: 2–30°C; protect from light.1
Prefilled injection pen: 25°C (may be exposed to 15–30°C); protect from light; do not refrigerate.279
Prefilled needleless device: 20–25°C (may be exposed to 15–30°C); do not freeze.280
Precise mechanism of action not established;4 6 9 13 77 87 may ameliorate migraine and cluster headache through selective constriction of certain large cranial blood vessels and/or inhibition of neurogenic inflammatory processes in the CNS.1 2 3 6 7 9 10 13 47 66 73 77 88 110 119 131 177 184 186 217 236 237
Advice to Patients
Risk of serious cardiovascular or cerebrovascular events (e.g., MI, stroke) or other vasospastic reactions.1 148 249 Importance of seeking medical care if symptoms of such reactions (e.g., shortness of breath, weakness, slurring of speech, sudden or severe abdominal pain, difficulty in seeing, or tightness, pain, pressure, or heaviness in chest, throat, jaw, or neck) occur and of not taking sumatriptan again until evaluated by a clinician.1 148 249
Importance of contacting clinician immediately if symptoms suggestive of hypersensitivity (e.g., shortness of breath, wheezing, palpitations, rash, urticaria, swelling of mouth, tongue, or throat) occur.1 148 249
Importance of providing patient a copy of manufacturer’s patient information.1 148 249 Importance of clinician providing adequate instructions, as well as the written administration instructions supplied with the autoinjection device or nasal spray, before first use.1 171 249 279 280
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal supplements, as well as any concomitant illnesses (e.g., cardiovascular disease).1 148 249
Importance of informing patients of risk of serotonin syndrome, particularly with concurrent use of sumatriptan and an SSRI, SNRI, MAO inhibitor, or tricyclic antidepressant.1 148 249 272 Importance of seeking immediate medical attention if symptoms of serotonin syndrome develop.1 148 249 272
Overuse of drugs indicated for the management of acute migraine attacks may exacerbate headaches; importance of recording headache frequency and drug use to monitor effectiveness of treatment.1 148 249 276
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
5 mg/0.1 mL*
Imitrex Nasal Spray
Sumatriptan Nasal Spray
20 mg/0.1 mL*
Imitrex Nasal Spray
Sumatriptan Nasal Spray
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
25 mg (of sumatriptan)*
Sumatriptan Succinate Tablets
50 mg (of sumatriptan)*
Sumatriptan Succinate Tablets
100 mg (of sumatriptan)*
Sumatriptan Succinate Tablets
Injection, for subcutaneous use only
4 mg (of sumatriptan) per 0.5 mL*
Imitrex (available in 0.5-mL unit-of-use injection-pen cartridges)
Sumatriptan Succinate Injection (available in 0.5-mL unit-of-use injection-pen cartridges)
6 mg (of sumatriptan) per 0.5 mL*
Alsuma (available in prefilled disposable single-use 0.5-mL injection pen)
Imitrex (available in 0.5-mL unit-of-use injection-pen cartridges and as 0.5-mL single-dose vials)
Sumatriptan Succinate Injection (available in 0.5-mL unit-of-use injection-pen cartridges and as 0.5-mL single-dose vials)
Sumavel (available in prefilled disposable single-use 0.5-mL needleless delivery device)
85 mg (of sumatriptan) with 500 mg Naproxen Sodium
AHFS DI Essentials. © Copyright, 2004-2016, Selected Revisions August 5, 2013. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
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