Drugs to Prevent Migraine in Adults

Full update November 2020

Preventive migraine meds can be considered for patients with frequent, severe, or hard-to-treat migraines, or migraines that interfere with life activities despite correct use of acute treatment and trigger avoidance.2 Patients unable to find effective acute treatment are also candidates.2 Base med selection on adverse effects, concomitant disease states, efficacy, and patient preference.2,3 To aid in selection, the table below summarizes role in therapy, efficacy, drug/drug or drug/disease interactions, common or serious adverse effects, select dosing info (adults), and other considerations.

Information in the following chart applies to migraine prevention in adults.

Efficacya

Avoid or use caution in…

Comments

ACEIs or ARBs (lisinopril, candesartan): second- or third-line,2,3 or if ACEI/ARB needed for another reason (e.g., hypertension), or for patients who place particular value on avoiding side effects.2

ACEIs or ARBs reduce migraine days around 25% vs placebo [Evidence level B-1].4,5

Patients with history of angioedema (avoid ACEIs), renal insufficiency, hypotension, volume depletion, hyperkalemia, pregnancy (avoid), or patients taking NSAIDs or diuretics.6,9

Aim for a dose of:2,4,5,26

  • lisinopril 20 mg once daily.
  • candesartan 16 mg once daily.

Beta-Blockers (metoprolol, propranolol, timolol): First-line,2,3 especially for patients who need a beta-blocker for another reason
(e.g., hypertension, angina).2

Over 40% (up to 80%) of patients achieve at least a 50% reduction in migraine frequency.8

Propranolol prevents one or two more migraines per month vs placebo
[Evidence level B-1].15

Asthma, second- or third-degree heart block, left ventricular dysfunction (metoprolol okay), peripheral vascular disease, physically active patients.2,6,9

Limit rizatriptan (Maxalt) to 5 mg/dose in patients taking propranolol.10

Propranolol and timolol FDA- and Health Canada-approved for migraine prevention. See our chart, Comparison of Oral Beta-Blockers (U.S.) (Canada) for dosing.

Metoprolol dose: 100 mg once daily. Increase every one to two weeks to a maximum dose of 200 mg once daily (metoprolol succinate [U.S.] or metoprolol tartrate SR [Canada]) or divided BID (metoprolol tartrate immediate-release).2

Atenolol and nadolol probably effective.3

Nebivolol has less evidence.3

Agents with intrinsic sympathomimetic activity (e.g., acebutolol, pindolol) may be ineffective.3

Consider use with a tricyclic, topiramate, or valproate to increase efficacy (and reduce side effects if one or both used at reduced dose).2

Botulinum Toxin (Botox): Patients with 15 or more headache days per month, with headache lasting ≥4 hours a day.12,13

Reduces headache days by about eight days per month (about two fewer than with placebo) [Evidence level A-1].12,13

Patients with episodic migraine (14 or fewer headache days per month); not likely effective.12

FDA- and Health Canada-approved for chronic migraines.12,13

Calcium Channel Blockers (nicardipine, verapamil): Third-line.3

Nicardipine reduces mean headache index score (frequency x severity) from 12.61 to 2.35 [Evidence level B-1].11

Nicardipine: peripheral edema, left ventricular dysfunction, tachycardia.9

Verapamil: second- or third-degree heart block, left ventricular dysfunction.6

Nicardipine has the best evidence of efficacy.3

Verapamil can be considered after trying other agents, but quality of evidence is poor.2

Nicardipine dose: 20 mg once daily for three days, then
20 mg BID.11

Verapamil dose: 40 mg TID. Increase to 80 mg TID over one to two weeks. Max 480 mg daily, divided. Can use SR product divided BID.2

Cyproheptadine: Third-line.3

Cyproheptadine 2 mg BID as effective as propranolol 40 mg BID [Evidence level B-1].15

Patients taking MAOIs or CNS depressants, patients involved in activities requiring alertness and coordination, patients in whom anticholinergic effects (e.g., dry mouth, constipation, urinary retention, cardiac effects, confusion) are undesirable.9

Dose: 2 to 4 mg BID.9

Weight gain and sedation common.14

Calcitonin Gene-Related Peptide (CGRP) antagonists (Parenteral) (eptinezumab, erenumab, fremanezumab, galcanezumab): Consider for patients with an inadequate response after an eight-week trial of at least two first-line oral meds or med combinations at optimal doses, or if oral non-CGRP meds aren't tolerated. Can be combined with non-CGRP oral agents.37,45,46,50,53

Prevents one or two more episodic migraines per month vs placebo.1,7,38,42-44

Reduces migraine days per month by at least 50% in almost 25% of patients (secondary endpoint) [Evidence level A-1].1,7,37,38,42-44

There are post-marketing reports of new onset and worsening hypertension with erenumab.47 Aimovig labeling (U.S.) now recommends monitoring for hypertension and, if it occurs, considering discontinuation of Aimovig if an alternate cause is not found.38

Theoretical concern for cardiac side effects because they antagonize calcitonin gene-related peptide, which is a vasodilator. Studies to date have not shown cardiovascular effects; however, most have excluded patients with significant cardiovascular risk factors.39

Latex allergy (Aimovig).38,42

Once-monthly subcutaneous self-injections (quarterly option with fremanezumab).1,7,38,42-44 Except eptinezumab, which is administered every three months in a healthcare setting.48,49

Eptinezumab (Vyepti) vial. Dose: 100 mg IV infusion over 30 minutes every three months, can increase to 300 mg every three months.48,49 Cost: $1,495/100 mg (U.S.), approved but not yet marketed in Canada.b

Erenumab (Aimovig) autoinjector. Dose: 70 mg/month; can increase to 140 mg/month (2 injections).38,42 Cost: $603.18/month (U.S.), $566.88/month (Canada).b

Fremanezumab (Ajovy) autoinjector (U.S.) or prefilled syringe. Dose: 225 mg/month. Alternate dose: 675 mg (3 injections) once every three months.1,43 Cost: $603.20/month (U.S.), $623/month (Canada).b

Galcanezumab (Emgality) prefilled syringe or autoinjector. Dose: 240 mg loading dose, then 120 mg/month.7,44 Cost: $603.60/month (U.S.), $663.50/month (Canada).b

Most common side effects are injection site reactions (exception eptinezumab), constipation (erenumab), and hypersensitivity reactions (eptinezumab).1,7,38,42-44,48,49

Hypersensitivity reactions requiring discontinuation and/or corticosteroid treatment have been reported within hours to one month after administration of Ajovy and Emgality.1,7,43,44

Refrigeration required. Stable at room temperature for 24 hours (Ajovy), seven days (Emgality; Aimovig [U.S.]), 14 days (Aimovig [Canada]), or eight hours after dilution (Vyepti).1,7.38,42-44,48,49

Calcitonin Gene-Related Peptide (CGRP) antagonists (Oral) (rimegepant [U.S.], atogepant [U.S.]): Consider as an alternative to injectable CGRP antagonists for patients with an inadequate response after an eight-week trial of at least two first-line oral meds or med combinations at optimal doses.

Prevents one migraine day per month vs placebo [Evidence level A-1].51,55

 

Reduces migraine days per month by at least 50% in about 50% of patients (secondary endpoint) [Evidence level A-1].51,55

 

Enhances migraine-specific health-related quality of life.51,55

Avoid with severe liver impairment (Child-Pugh C), and end-stage renal disease (CrCl <15 mL/min) (rimegepant).52,54

 

Atogepant: dose adjustment needed with severe or end-stage renal impairment (CrCl <30 mL/min), strong CYP3A4 inhibitors, strong and moderate CYP3A4 inducers, and OATP inhibitors (see product labeling).54

 

Rimegepant: Avoid with strong CYP3A4 inhibitors, strong or moderate CYP3A4 inducers, or inhibitors of P-gp or BCRP.  Dosing interval adjustment needed with moderate CYP3A4 inhibitors (see product labeling).52

 

Theoretical concern for cardiac side effects because they antagonize calcitonin gene-related peptide, which is a vasodilator.  Studies to date have not shown cardiovascular effects; however, most have excluded patients with significant cardiovascular risk factors.39,51,54

Rimegepant (Nurtec ODT) oral disintegrating tablet.  Dose:  75 mg every other day.  Max dose of 1 tablet per day or 18 tabs/month (includes both acute [if used] and preventive doses).52  Cost:  $1,785/16 tablets (one month preventive dosing) (U.S.).b

 

Atogepant (Qulipta) tablet. Dose:  10 mg, 30 mg, OR
60 mg once daily.  Max dose of 60 mg/day.54  Cost:  $991/month (all strengths) (U.S.).b

 

Patients can use rimegepant for both prevention and acute migraine treatment; however, doses for acute migraine treatment should NOT be used on the same day a regular preventive dose is due.52

 

Can be used with other meds for acute episodes (e.g., triptans, NSAIDs, etc).51,55

 

Most common side effects are nausea, abdominal pain/dyspepsia (rimegepant), constipation (atogepant), and fatigue (atogepant).52,54

Gabapentin: Third-line,3 or for patients for whom drug interactions are a concern, for patients who could benefit from gabapentin for another indication (e.g., seizure disorder), or as a better-tolerated valproate alternative.2

Based on available data, does NOT appear to be better than placebo in reducing headache frequency by 50% [Evidence level B-2].17

Patients involved in activities requiring alertness and coordination (may cause drowsiness or dizziness), patients with renal impairment (requires renal dose adjustment), or patients for whom weight gain is a concern.2

Gabapentin dose: 300 mg/day, increase by 300 mg every three to five days. Target dose is 1,200 to 1,500 mg/day, divided TID.2 Max total daily dose is 2,400 mg.16

Sedation and dizziness are common.16

Pregabalin is not more effective than a subtherapeutic dose of sodium valproate (200 mg BID) [Evidence level B-1].41

Pizotifen (Sandomigran) (Canada): Third-line.18

Over 40% of patients have at least a 50% reduction in migraine frequency [Evidence level B-1].19

Patients taking MAOIs (contraindication) or CNS depressants; patients with GI obstruction (contraindication); patients in whom anticholinergic effects (e.g., dry mouth, constipation, urinary retention, cardiac effects, confusion) are undesirable; patients involved in activities requiring alertness; or patients with diabetes, cardiovascular disease, or liver or renal impairment.20

Weight gain and sedation are common.18

Topiramate (Topamax): First-line.3 Consider for patients concerned about weight gain.2 May be effective for chronic daily headache (15 or more headache days/month).21

Can reduce migraine frequency by at least 50% in almost half of patients [Evidence level A-1].22

Prevents one or two more migraines per month vs placebo.22

Women on oral contraceptives (potential for reduced contraceptive efficacy, especially at daily dose over 200 mg), patients involved in activities requiring alertness and coordination, patients with renal impairment (requires dose adjustment).23,24,29,30

Per Canadian labeling, contraindicated for migraine prevention in women who are or may become pregnant.24

Fetal concerns include cleft lip/palate and small for gestational age.23,29,30

FDA- and Health Canada- approved for migraine prevention.23,24,29,30

Dose: initial 25 mg at bedtime. Increase by 25 mg/day weekly; target 100 mg daily, divided BID,23,24 or once-daily for ER formulations.29,30

Associated with several serious side effects such as angle closure glaucoma, hyperthermia, metabolic acidosis, kidney stones, hyperammonemia, and encephalopathy.23,24,29,30

Other adverse effects include paresthesia, fatigue, headache, dizziness, sleepiness, nausea, weight loss.23,24,29,30
ER formulations may cause less cognitive impairment.31

Consider use with beta-blocker or tricyclic to increase efficacy (and reduce side effects if one or both used at reduced dose).2

Tricyclic Antidepressants (amitriptyline): First- or second-line.32,3 Consider for patients with insomnia or depression (adjunct).2 Also effective for tension-type headaches.25

Tricyclics increase chance of at least 50% improvement in headaches by about 80% vs placebo. Number of migraines per month reduced by 1.4 on average [Evidence level B-2].25 Studies limited by high drop-out rate.2

Amitriptyline may be as effective as topiramate [Evidence level A-2].26

Patients in whom anticholinergic effects (e.g., dry mouth, constipation, urinary retention, cardiac effects, confusion) or weight gain are undesirable.2

Amitriptyline dose: initial 10 mg at bedtime. Increase by
10 mg every one to two weeks. Target dose 20 to 40 mg at bedtime. Max dose is 150 mg per day.2

Amitriptyline has the most data.25

Nortriptyline often used despite lack of controlled trial evidence of efficacy. Dose as for amitriptyline.2

Clomipramine (Anafranil) and doxepin not effective per available data.2

Consider use with a beta-blocker or topiramate to increase efficacy (and reduce side effects if one or both used at a reduced dose).2,27

Valproic Acid/Divalproex: First-line.2

Over 40% of patients have at least a 50% reduction in migraine frequency [Evidence level A-1].28

Prevents about one more migraine per month vs placebo.28

Liver disease, alcoholism, history of pancreatitis, urea cycle disorders, bleeding disorders, women who are or may become pregnant (risk of neural tube defects).2,9,16

Divalproex FDA-approved for migraine prevention.9 Can use valproic acid, but divide daily doses over 250 mg (i.e., BID) and over 500 mg (i.e., TID).2,32,33,40

Divalproex dosing: 250 mg once daily or BID (ER formulation: 500 mg once daily). Increase by 250 mg each week to a target dose of 750 to 1,500 mg/day, divided BID (ER formulation: 1,000 mg once daily).2,9

Consider targeting valproic acid trough levels of 70 to 120 mcg/mL.9 Check level if toxicity or nonadherence suspected.34

GI side effects most common during first six months.14 Divalproex formulations may lead to less GI side effects.14,40

Other side effects include sleepiness, weight gain, hair loss, tremor (dose-dependent), dose-dependent thrombocytopenia (which may resolve despite continued therapy), and rarely hepatotoxicity, hyperammonemia, and pancreatitis.2,9,35,40

Consider use with a beta-blocker to increase efficacy (and reduce side effects if one or both used at reduced dose).2,35

Venlafaxine extended-release (Effexor XR): Second-line.3 Consider for patient with depression or anxiety.2

Reduces headache severity and frequency (median reduction vs placebo: three fewer over two months) [Evidence level B-1].36

Hypertension, heart disease, seizure disorder, MAOI use within 14 days (avoid).9

Dose: 37.5 mg once daily for one week. Increase weekly by 37.5 to 75 mg/day. Target 150 mg once daily.2

Side effects: nausea, vomiting, drowsiness, dizziness, blurred vision.2

Abbreviations: ACEI = angiotensin-converting enzyme inhibitor; ARB = angiotensin receptor blocker; BID = twice daily; CNS = central nervous system; GI = gastrointestinal; MAOI = monoamine oxidase inhibitor; SR = sustained release; TID = three times daily.

  1. Efficacy: Once titrated to the target dose, it may take eight to 12 weeks to see maximum benefit from a prophylactic medication, although some benefit may be seen within the first month.2 Have patients keep a headache diary to help assess efficacy.2 Efficacy is usually defined as a 50% reduction in headache days per month, but other considerations include reduction in headache severity, reduced impact on daily life, and medication tolerability.2 Trial and error may be required to find the best option.3 After six to 12 months of successful use, consider a trial of tapering and discontinuing the medication.2 If needed, increase the dose or restart the medication.2
  2. Wholesale acquisition cost (U.S.). Medication pricing by Elsevier, accessed October 2020. (Nurtec ODT accessed July 2021, Qulipta accessed November 2021). Canadian cost is wholesale.

Levels of Evidence

In accordance with our goal of providing Evidence-Based information, we are citing the LEVEL OF EVIDENCE for the clinical recommendations we publish.

Level

Definition

Study Quality

A

Good-quality patient-oriented evidence.*

  1. High-quality RCT
  2. SR/Meta-analysis of RCTs with consistent findings
  3. All-or-none study

B

Inconsistent or limited-quality patient-oriented evidence.*

  1. Lower-quality RCT
  2. SR/Meta-analysis with low-quality clinical trials or of studies with inconsistent findings
  3. Cohort study
  4. Case control study

C

Consensus; usual practice; expert opinion; disease-oriented evidence (e.g., physiologic or surrogate endpoints); case series for studies of diagnosis, treatment, prevention, or screening.

*Outcomes that matter to patients (e.g., morbidity, mortality, symptom improvement, quality of life).

RCT = randomized controlled trial; SR = systematic review [Adapted from Ebell MH, Siwek J, Weiss BD, et al. Strength of Recommendation Taxonomy (SORT): a patient-centered approach to grading evidence in the medical literature. Am Fam Physician 2004;69:548-56. http://www.aafp.org/afp/2004/0201/p548.pdf.]

Prepared by the Editors of Therapeutic Research Center (361119); last modified November 2021.

References

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  2. Pringsheim T, Davenport W, Mackie G, et al. Canadian Headache Society guideline for migraine prophylaxis. Can J Neurol Sci 2012;39(Suppl 2):S1-S59.
  3. Silberstein SD, Holland S, Freitag F, et al. Evidence-based guideline update: pharmacologic treatment for episodic migraine prevention in adults: report of the Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Neurology 2012;78:1337-45. Erratum in Neurology 2013;80:871.
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  5. Tronvik E, Stovner LJ, Helde G, et al. Prophylactic treatment of migraine with angiotensin II receptor blocker a randomised controlled trial. JAMA 2003;289:65-9.
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Cite this document as follows: Clinical Resource, Drugs to Prevent Migraine in Adults. Pharmacist’s Letter/Prescriber’s Letter. November 2020.

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