Uses

Vascular Headaches

Acute treatment of migraine attacks with or without aura.

Sub-Q for acute treatment of cluster headache episodes. Safety and efficacy of oral or intranasal sumatriptan for this use not established.

Not recommended for management of hemiplegic or basilar migraine or for prophylaxisof migraine or cluster headache.

Dosage and Administration

Administration

Administer orally, intranasally, or by sub-Q injection. Do not administer IM or IV; IV administration may induce coronary vasospasm.

To achieve maximum relief, initiate therapy as soon as possible after onset of migraine attack.

Oral Administration

Administer orally with fluids; swallow tablet whole.

Intranasal Administration

Administer intranasally as a single spray into 1 nostril.

Nasal solution unit contains only 1 spray; do not test before use.

To administer, remove unit from package just before use. While sitting down, gently blow nose to clear nasal passages. Keep head in upright position and gently close 1 nostril with index finger; exhale gently through mouth. With other hand, hold unit with thumb supporting at bottom and index and middle fingers on either side of nozzle. Insert nozzle into open nostril about ½ inch. While gently inhaling through nose (with closed mouth), release spray by firmly pressing plunger. 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. Consult administration instructions provided by manufacturer before use.

Sub-Q Administration

Administer only by sub-Q injection, preferably into lateral aspect of thigh or deltoid.

Do not administer IM or IV; IV administration may induce coronary vasospasm.

Autoinjection device available for use with prefilled syringes (each containing a 4- or 6-mg dose) to facilitate self-administration. Needles with this device penetrate approximately 5–6 mm (¼ inch); use injection sites with an adequate skin and subcutaneous thickness to accommodate needle length.

Dosage

Available as sumatriptan (nasal solution) and sumatriptan succinate (tablets and injection); dosage expressed in terms of sumatriptan.

Following failure to respond to first dose, reconsider diagnosis of migraine prior to administration of a second dose.

Adults

Vascular Headaches

Migraine

Oral

25, 50, or 100 mg as a single dose. 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.

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.

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.

Intranasal

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. Doses >20 mg provide no additional benefit.

To achieve a 10-mg dose, administer a single 5-mg dose into each nostril.

If headache recurs, dose may be repeated once after 2 hours, up to a maximum dosage of 40 mg daily.

Sub-Q

≤6 mg as a single dose. If dose-limiting adverse effects occur with 6-mg dose, lower doses (e.g., 4 mg) may be given. 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.

If headache recurs, a 6-mg sub-Q dose may be repeated once after ≥1 hour or additional oral doses may be administered at intervals ≥2 hours, up to a maximum oral dosage of 100 mg daily.

If patient does not respond to first 6-mg dose, additional doses are unlikely to provide benefit.

Cluster Headache

Sub-Q

≤6 mg as a single dose. If dose-limiting adverse effects occur with 6-mg dose, lower doses may be administered using only single-dose vials; use autoinjection device only with prefilled, unit-of-use syringes containing 6 mg.

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.

If patient does not respond to first 6-mg dose, additional doses are unlikely to provide benefit.

Prescribing Limits

Adults

Vascular Headaches

Migraine

Oral

Maximum 200 mg daily; do not exceed 100 mg daily if following an initial sub-Q dose.

Safety of treating an average of >4 headaches per 30-day period has not been established.

Intranasal

Maximum 40 mg daily.

Safety of treating an average of >4 headaches per 30-day period has not been established.

Sub-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.

Cluster Headache

Sub-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.

Special Populations

Dosage in Hepatic Impairment

Contraindicated in patients with severe hepatic impairment. Unpredictable increases in bioavailability following oraladministration in patients with hepatic impairment. If oral therapy is deemed advisable in these patients, do not exceed 50 mg as a single dose.

Patients Receiving MAO-A Inhibitors

Concurrent or recent (within 2 weeks) use of MAO-A inhibitor and oral or intranasal sumatriptan is contraindicated; sub-Qsumatriptan is not generally recommended, but if concomitant use is clinically warranted, decrease sumatriptan sub-Q dosage and administer under careful medical supervision.