Almotriptan

Almotriptan binds with high affinity to 5-HT 1D , 5-HT 1B , and 5-HT 1F receptors. Almotriptan has weak affinity for 5-HT 1A and 5-HT 7 receptors, but has no significant affinity or pharmacological activity at 5-HT 2 , 5-HT 3 , 5-HT 4 , 5-HT 6 ; alpha or beta adrenergic; adenosine (A 1 , A 2 ); angiotensin (AT 1 , AT 2 ); dopamine (D 1 , D 2 ); endothelin (ET A , ET B ); or tachykinin (NK 1 , NK 2 , NK 3 ) binding sites.

• Almotriptan tablets are a 5HT 1B/1D receptor agonist (triptan) indicated for: • Acute treatment of migraine attacks in adults with a history of migraine with or without aura ( 1.1 ) • Acute treatment of migraine headache pain in adolescents age 12 to 17 years with a history of migraine with or without aura, and who have migraine attacks usually lasting 4 hours or more ( 1.1 ) Important Limitations: • Use only after a clear diagnosis of migraine has been established ( 1.2 ) • In adolescents age 12 to 17 years, efficacy of almotriptan tablets on migraine-associated symptoms was not established ( 1.2 ) • Not intended for the prophylactic therapy of migraine ( 1.2 ) • Not indicated for the treatment of cluster headache ( 1.2 ) 1.1 Acute Treatment of Migraine Attacks Adults Almotriptan tablets (almotriptan malate) are indicated for the acute treatment of migraine attacks in patients with a history of migraine with or without aura. Adolescents Age 12 to 17 Years Almotriptan tablets are indicated for the acute treatment of migraine headache pain in patients with a history of migraine attacks with or without aura usually lasting 4 hours or more (when untreated).ICD-10: G43.909, R51.9

• • Ischemic heart disease, coronary artery vasospasm, or other significant underlying cardiovascular disease ( 4.1 ) • Cerebrovascular syndromes (e.g., history of stroke or TIA) ( 4.2 ) • Peripheral vascular disease (including ischemic bowel disease) ( 4.3 ) • Uncontrolled hypertension ( 4.4 ) • Do not use almotriptan tablets within 24 hours of an ergotamine-containing, or ergot-type medication, or of another 5-HT 1 agonist, e.g., another triptan ( 4.5 , 4.6 ) • Hemiplegic or basilar migraine ( 4.7 ) • Known hypersensitivity to almotriptan tablets ( 4.8 ) 4.1 Ischemic or Vasospastic Coronary Artery Disease, or Other Significant Underlying Cardiovascular Disease Do not use almotriptan tablets (almotriptan malate) in patients with ischemic heart disease (angina pectoris, history of myocardial infarction, or documented silent ischemia), or in patients who have symptoms or findings consistent with ischemic heart disease, coronary artery vasospasm, including Prinzmetal’s variant angina, or other significant underlying cardiovascular disease [see Warnings and Precautions (5.1) ] .contraindicated

• Adults and adolescents age 12 to 17 years: 6.25 mg or 12.5 mg single dose; may repeat after 2 hours if headache returns; benefit of second dose in patients who have failed to respond to first dose has not been established; maximum daily dose 25 mg ( 2.1 ) • Patients with hepatic or severe renal impairment: 6.25 mg starting dose; maximum daily dose 12.5 mg ( 2.2 , 2.3 ) 2.1 Acute Treatment of Migraine Attacks The recommended dose of almotriptan tablets (almotriptan malate) in adults and adolescents age 12 to 17 years is 6.25 mg to 12.5 mg, with the 12.5 mg dose tending to be a more effective dose in adults. As individuals may vary in their response to different doses of almotriptan tablets, the choice of dose should be made on an individual basis. If the headache is relieved after the initial almotriptan tablet dose but returns, the dose may be repeated after 2 hours. The effectiveness of a second dose has not been established in placebo-controlled trials. The maximum daily dose should not exceed 25 mg. The safety of treating an average of more than four migraines in a 30-day period has not been established. 2.2 Hepatic Impairment The recommended starting dose of almotriptan tablets in patients with hepatic impairment is 6.25 mg. The maximum daily dose should not exceed 12.5 mg over a 24-hour period [see Warnings and Precautions (5.9) and Clinical Pharmacology (12.3) ] . 2.3 Renal Impairment The recommended starting dose of almotriptan tablets in patients with severe renal impairment is 6.25 mg.

• Serious adverse cardiac events, including acute myocardial infarction and life-threatening disturbances of cardiac rhythm ( 5.1 ) • It is strongly recommended that almotriptan tablets not be given to patients in whom unrecognized coronary artery disease (CAD) is predicted by the presence of risk factors. In very rare cases, serious cardiovascular events have been reported in association with almotriptan tablet use in the absence of known cardiovascular disease. If almotriptan tablets are considered, patients should first have a cardiovascular evaluation. If the evaluation is satisfactory, first dose should take place in a physician’s office setting ( 5.1 ) • Sensations of pain, tightness, pressure, and heaviness in the chest, throat, neck, and jaw: generally not associated with myocardial ischemia, but patients with signs or symptoms suggestive of angina should be evaluated for the presence of CAD ( 5.2 ) • Cerebrovascular events, some fatal ( 5.3 ) • Gastrointestinal ischemic events and peripheral vasospastic reactions (e.g., Raynaud’s syndrome) ( 5.4 ) • Potentially life-threatening serotonin syndrome, particularly in combination with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs).

Serious cardiac reactions, including myocardial infarction, have occurred following the use of almotriptan (almotriptan malate) tablets. These reactions are extremely rare and most have been reported in patients with risk factors predictive of CAD. Reactions reported in association with triptans have included coronary artery vasospasm, transient myocardial ischemia, myocardial infarction, ventricular tachycardia, and ventricular fibrillation [see Contraindications (4.1) and Warnings and Precautions (5.1) ] . The following adverse reactions are discussed in more detail in other sections of the labeling: • Risk of Myocardial Ischemia and Infarction and Other Adverse Cardiac Events [see Warnings and Precautions (5.1) ] • Sensations of Pain, Tightness, Pressure in the Chest and/or Throat, Neck, and Jaw [see Warnings and Precautions (5.2) ] • Cerebrovascular Events and Fatalities [see Warnings and Precautions (5.3) ] • Other Vasospasm-Related Events, Including Peripheral Vascular Ischemia and Colonic Ischemia [see Warnings and Precautions (5.4) ] • Serotonin Syndrome [see Warnings and Precautions (5.5) ] • Increases in Blood Pressure [see Warnings and Precautions (5.7) ] Adverse events were assessed in controlled clinical trials that included 1840 adult patients who received one or two doses of almotriptan tablets and 386 adult patients who received placebo. The most common adverse reactions during treatment with almotriptan tablets were nausea, somnolence, headache, paresthesia, and dry mouth.

• Pregnancy: based on animal data, may cause fetal harm ( 8.1 ) • Nursing mothers: use almotriptan tablets with caution ( 8.3 ) • Pediatric use: almotriptan tablets have not been studied in children under 12 years ( 8.4 ) • Geriatric use: insufficient safety and efficacy data; use with caution, usually starting with the 6.25 mg dose ( 8.5 ) • Hepatic impairment: use single 6.25 mg tablet as a starting dose; maximum daily dose 12.5 mg ( 2.2 , 8.6 ) • Severe renal impairment: use single 6.25 mg tablet as a starting dose; maximum daily dose 12.5 mg ( 2.3 , 8.7 ) 8.1 Pregnancy Pregnancy Category C In animal studies, almotriptan produced developmental toxicity (increased embryolethality and fetal skeletal variations, and decreased offspring body weight) at doses greater than those used clinically. There are no adequate and well-controlled studies in pregnant women; therefore, almotriptan tablets (almotriptan malate) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. When almotriptan (125 mg/kg/day, 250 mg/kg/day, 500 mg/kg/day, or 1000 mg/kg/day) was administered orally to pregnant rats throughout the period of organogenesis, increased incidences of fetal skeletal variations (decreased ossification) were noted at a dose of 250 mg/kg/day or greater and an increase in embryolethality was seen at the highest dose.

Metabolism

Absorption The absolute bioavailability of almotriptan is about 70%, with peak plasma levels occurring 1 to 3 hours after administration; food does not affect pharmacokinetics. Distribution Almotriptan is minimally protein bound (approximately 35%) and the mean apparent volume of distribution is approximately 180 to 200 liters.

10.1 Signs and Symptoms Patients and volunteers receiving single oral doses of 100 mg to 150 mg of almotriptan did not experience significant adverse events. Six additional normal volunteers received single oral doses of 200 mg without serious adverse events. During clinical trials with almotriptan tablets (almotriptan malate), one patient ingested 62.5 mg in a 5-hour period and another patient ingested 100 mg in a 38-hour period. Neither patient experienced adverse reactions. Based on the pharmacology of triptans, hypertension or other more serious cardiovascular symptoms could occur after overdosage. 10.2 Recommended Treatment There is no specific antidote to almotriptan tablets. In cases of severe intoxication, intensive care procedures are recommended, including establishing and maintaining a patent airway, ensuring adequate oxygenation and ventilation, and monitoring and support of the cardiovascular system. Clinical and electrocardiographic monitoring should be continued for at least 20 hours even if clinical symptoms are not observed. It is unknown what effect hemodialysis or peritoneal dialysis has on plasma concentrations of almotriptan.

• Jul 7, 2015ANDAANDA078027Teva Pharms Usa
• Nov 9, 2015ANDAANDA205171Mylan
• Mar 3, 2016ANDAANDA205523Ajanta Pharma Ltd

1. 1Hyperhidrosis41343%
2. 2Drug Ineffective41243%
3. 3Nightmare38040%
4. 4Sedation37840%
5. 5Nausea36238%
6. 6Off Label Use35137%
7. 7Product Use In Unapproved Indication30232%
8. 8Nephrolithiasis29431%
9. 9Headache778.1%
10. 10Migraine747.8%
11. 11Fatigue656.8%
12. 12Pain606.3%
13. 13Somnolence495.1%
14. 14Product Used For Unknown Indication424.4%
15. 15Vomiting384.0%

The 10 most recently updated of 16 ClinicalTrials.gov registrations naming Almotriptan as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• ACT Therapy for HF Migraine
  Completed · Interventional · 64 enrolled · Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
  NCT03461874updated 2026-02-11
• Evaluation of the Efficacy of Almotriptan and Ubrogepant for the Acute Treatment of Migraine
  Terminated · Phase 4 · Interventional · 8 enrolled · Messoud Ashina, MD
  NCT05214001updated 2025-05-31
• Treatments of Migraine with Triptans in Individuals with Elevated Cardiovascular Risk and in Pregnant Women
  Completed · Observational · 68,419 enrolled · Mayo Clinic
  NCT05854992updated 2024-12-02
• Does Treximet Improve Productivity and Patient Satisfaction Due to Sustained Response and Consistency of Response?
  Completed · Phase 4 · Interventional · 60 enrolled · The Cleveland Clinic
  NCT01086358updated 2018-05-01
• Treximet ™ Pharmacy Budget Impact Model Database Validation Study
  Completed · Observational · 61,737 enrolled · GlaxoSmithKline
  NCT01332500updated 2017-05-30
• Non-steroidal Anti-inflammatory Drugs Alone or With a Triptan and Reports of Transition From Episodic to Chronic Migraine
  Completed · Observational · 11,249 enrolled · GlaxoSmithKline
  NCT01435941updated 2017-05-16
• Standardized sTudy With Almotriptan in eaRly Treatment of Migraine
  Completed · Observational · 501 enrolled · Almirall, S.A.
  NCT00725140updated 2015-06-01
• A 1-year Study in Adolescents to Assess the Long-term Safety of Almotriptan Malate When Treating Their Migraine Headaches
  Completed · Phase 3 · Interventional · 447 enrolled · Janssen-Ortho LLC
  NCT00257010updated 2014-02-21
• A Combination Product of Sumatriptan and Naproxen Sodium Versus Single-entity Oral Triptans: An Analysis of Real World Data
  Completed · Observational · 1 enrolled · GlaxoSmithKline
  NCT01381523updated 2013-02-25
• Impact of Migraine on Work Productivity in Patients Treated With a Combination Product Containing Sumatriptan and Naproxen Sodium or Triptan Monotherapy
  Completed · Observational · 1 enrolled · GlaxoSmithKline
  NCT01381497updated 2012-08-27

Frequently asked questions

How does Almotriptan work?

Almotriptan binds with high affinity to 5-HT 1D , 5-HT 1B , and 5-HT 1F receptors. Almotriptan has weak affinity for 5-HT 1A and 5-HT 7 receptors, but has no significant affinity or pharmacological activity at 5-HT 2 , 5-HT 3 , 5-HT 4 , 5-HT 6 ; alpha or beta adrenergic; adenosine (A 1 , A 2 ); angiotensin (AT 1 , AT 2 ); dopamine (D 1 , D 2 ); endothelin (ET A , ET B ); or tachykinin (NK 1 , NK 2 , NK 3 ) binding sites.

What is Almotriptan used for?

According to FDA labeling, Almotriptan carries indications including: Almotriptan tablets are a 5HT 1B/1D receptor agonist (triptan) indicated for: • Acute treatment of migraine attacks in adults with a history of migraine with or without aura ( 1.1 ) • Acute treatment of migraine headache pain in adolescents age 12 to 17 years with a history of migraine with or without aura, and who have migraine attacks usually lasting 4 hours or more ( 1.1 ) Important Limitations: • Use only after a clear diagnosis of migraine has been established ( 1.2 ) • In adolescents age 12 to 17 years, efficacy of almotriptan tablets on migraine-associated symptoms was not established ( 1.2 ) • Not intended for the prophylactic therapy of migraine ( 1.2 ) • Not indicated for the treatment of cluster headache ( 1.2 ) 1.1 Acute Treatment of Migraine Attacks Adults Almotriptan tablets (almotriptan malate) are indicated for the acute treatment of migraine attacks in patients with a history of migraine with or without aura. Adolescents Age 12 to 17 Years Almotriptan tablets are indicated for the acute treatment of migraine headache pain in patients with a history of migraine attacks with or without aura usually lasting 4 hours or more (when untreated).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Almotriptan?

Almotriptan is classified as Selective serotonin (5HT1) agonists, Serotonin-1b and Serotonin-1d Receptor Agonist, Monoamine Oxidase Inhibitors, Serotonin 1b Receptor Agonists, Serotonin 1d Receptor Agonists, Serotonin Agonists, Cerebral Arterial Vasoconstriction, Increased Central Nervous System Serotonin Activity.

What are the contraindications for Almotriptan?

Almotriptan labeling lists contraindications including: • Ischemic heart disease, coronary artery vasospasm, or other significant underlying cardiovascular disease ( 4.1 ) • Cerebrovascular syndromes (e.g., history of stroke or TIA) ( 4.2 ) • Peripheral vascular disease (including ischemic bowel disease) ( 4.3 ) • Uncontrolled hypertension ( 4.4 ) • Do not use almotriptan tablets within 24 hours of an ergotamine-containing, or ergot-type medication, or of another 5-HT 1 agonist, e.g., another triptan ( 4.5 , 4.6 ) • Hemiplegic or basilar migraine ( 4.7 ) • Known hypersensitivity to almotriptan tablets ( 4.8 ) 4.1 Ischemic or Vasospastic Coronary Artery Disease, or Other Significant Underlying Cardiovascular Disease Do not use almotriptan tablets (almotriptan malate) in patients with ischemic heart disease (angina pectoris, history of myocardial infarction, or documented silent ischemia), or in patients who have symptoms or findings consistent with ischemic heart disease, coronary artery vasospasm, including Prinzmetal’s variant angina, or other significant underlying cardiovascular disease [see Warnings and Precautions (5.1) ] .. Always consult the full prescribing information and a clinician.