Botox for migraines: how it works, who qualifies, and what to expect

Botox for migraines is one of the most evidence-backed uses of the toxin — and one of the least understood among patients who primarily know it as a cosmetic treatment. Here's what it actually is, who qualifies, and what the evidence shows.

FDA approval and indication

Botox (onabotulinumtoxinA) received FDA approval for chronic migraine in 2010. This is a distinct FDA indication from cosmetic use.

The exact FDA indication: Prevention of headache in adults with chronic migraine — defined as:
15 or more headache days per month
At least 8 of those days meeting migraine criteria
Headache duration of 4+ hours per day on those days

This does NOT include: Episodic migraine (fewer than 15 headache days/month), tension headache alone, or other headache types. Botox has not shown benefit for episodic migraine in clinical trials and is not FDA-approved for that purpose.

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How Botox prevents migraines

The cosmetic mechanism (blocking acetylcholine at the neuromuscular junction → muscle relaxation) is related but not sufficient to explain migraine prevention. The current evidence supports that:

Peripheral sensitization: In chronic migraine, peripheral sensory neurons become hypersensitized — they fire at lower thresholds. Botox injected into pericranial and cervical muscles appears to inhibit nociceptive neurotransmitter release (specifically substance P and CGRP) from sensory nerve terminals in those muscles.

Preventing central sensitization: By dampening peripheral signal input, Botox may reduce the "wind-up" of central sensitization that underlies chronic migraine's self-perpetuating cycle.

Muscle tension reduction: Reduced tension in the pericranial muscles may reduce a peripheral trigger source, though this alone doesn't fully explain the clinical benefit.

Timeline note: Unlike cosmetic Botox where results are visible in days, migraine prevention benefit typically accumulates over 2–3 treatment cycles (6–9 months). The first treatment cycle often produces modest results; maximum benefit is typically seen after 2–3 cycles.

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The PREEMPT protocol

Botox for chronic migraine is administered using the PREEMPT (Phase 3 REsearch Evaluating Migraine Prophylaxis Therapy) protocol — a fixed injection pattern across 7 head and neck muscle groups. This is not the same as cosmetic injection; the areas, depths, and doses differ.

Injection sites:
Frontalis (forehead)
Corrugator supercilii
Procerus
Occipitalis
Temporalis
Trapezius
Cervical paraspinal muscles

Total dose: 155 units per treatment cycle (standard PREEMPT). Additional "follow-the-pain" injections (up to 40 additional units) can be added based on patient-reported pain distribution.

Frequency: Every 12 weeks (quarterly).

Who administers it: Neurologists with headache specialty are the primary prescribers. Some pain management specialists and trained internists also administer the protocol. This is not typically performed by a cosmetic injector at a med spa — it requires a neurological assessment and diagnosis of chronic migraine.

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Clinical evidence

The two PREEMPT trials (PREEMPT 1 and PREEMPT 2) are the pivotal trials supporting FDA approval.

PREEMPT 1 findings (N=679):
Significant reduction in frequency of headache days at 24 weeks vs. placebo
Reduction in total cumulative headache hours
Primary endpoint: mixed (some primary endpoints missed; secondary endpoints met)

PREEMPT 2 findings (N=705):
Significant reduction in headache days/month
Reduction in migraine days, headache episodes
Both primary endpoints met

Pooled analysis:
~8–9 fewer headache days/month vs ~6–7 fewer for placebo (approximately 2 additional headache-free days/month vs placebo)
Approximately 50% response rate (≥50% reduction in headache days) in Botox vs ~35% for placebo
Number needed to treat (NNT): approximately 3–5 to achieve 50% reduction in a patient with chronic migraine

The honest picture: Botox for chronic migraine produces real, clinically meaningful reduction in headache burden. The effect size is moderate, not dramatic for every patient — but for patients who haven't responded to oral preventives, it's an important option with a strong evidence base and FDA backing.

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What to expect

Before treatment:
Neurological evaluation and formal diagnosis of chronic migraine (15+ headache days/month)
Discussion of prior preventive treatments tried (oral preventives like topiramate, valproate, amitriptyline, propranolol are usually tried first)
CGRP monoclonal antibodies (aimovig, emgality, ajovy) are a newer alternative/complement — discuss with your neurologist

The treatment session:
Multiple injections across the head and neck — 31–39 injection points per PREEMPT protocol
Duration: 15–20 minutes
Pain level: Mild — the needles used are fine; most patients describe mild stinging at occipital and trapezius points
No downtime. Avoid lying down for 4 hours post-injection (same precaution as cosmetic Botox)

After treatment:
Initial response may take 2–4 weeks; some patients see benefit earlier
Full evaluation of response is made at the end of the 12-week cycle (before the next treatment)
If no benefit at 2 treatment cycles, the regimen is typically reconsidered

Side effects:
Neck pain/stiffness (most common, related to trapezius/cervical injections): resolves within days
Injection site bruising or soreness: typical
Eyelid ptosis: rare but possible if frontalis injections are too high (same risk as cosmetic forehead Botox)
Dysphagia: very rare at standard PREEMPT doses; more relevant if cervical doses are high

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Insurance coverage

Unlike cosmetic Botox, Botox for chronic migraine is typically covered by health insurance when:
The chronic migraine diagnosis is formally documented
The patient has trialed and failed 2+ oral preventive medications
The treating provider is a neurologist (some insurers require neurology billing)

Coverage processes:
Prior authorization is almost universally required — the prescribing neurologist submits documentation of the diagnosis, headache diary data, and prior treatment failures
The authorization process can take 2–8 weeks
Some insurers require step-therapy (CGRP antibodies before Botox, or vice versa)

Cost without insurance: ~$1,500–$3,000 per treatment cycle for the toxin alone, plus provider fees. The Allergan Botox Savings Program offers patient assistance for those who qualify.

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How it differs from cosmetic Botox

| Factor | Cosmetic Botox | Botox for Migraines |
|---|---|---|
| Indication | Facial lines | Chronic migraine prevention |
| Injection pattern | Specific facial muscles | PREEMPT head/neck protocol |
| Total dose | 20–100 units typically | 155–195 units |
| Who administers | Cosmetic injectors, MDs, NPs | Neurologists, headache specialists |
| Evidence base | Cosmetic trials | Phase 3 RCTs (PREEMPT) |
| Insurance | Not covered | Covered with prior auth |
| Frequency | 3–4 months | 12 weeks (quarterly) |

One practical note: The doses are higher for migraine treatment. Cosmetic providers are not the right setting for migraine Botox, and neurologists are not the right setting for cosmetic treatment.

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Is Botox right for your migraines?

Talk to a headache neurologist if:
You have 15+ headache days/month with at least 8 meeting migraine criteria
You've tried 2+ preventive medications without adequate response
Your migraines are significantly impacting quality of life

The decision involves considering alternatives (CGRP antibodies, other oral preventives, nerve block procedures) and your individual response history. Botox is a validated option — but migraine management is a shared decision with a neurologist, not a med spa decision.

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