Melatonin is a hormone produced by the pineal gland located in the brain. The release of melatonin helps us fall asleep. Melatonin supplements have been used to treat insomnia. The results of clinical trials, however, are contradictory. This may be because a wide variety of doses have been used. One study suggests that 3 mg of melatonin – a common dose sold in stores – is less effective than 0.3 mg. I usually recommend 0.3 mg (300 mcg) for both insomnia and jet lag.

Melatonin has been tested for the prevention and acute treatment of migraines.

Melatonin was not effective in a study by Norwegian doctors. They gave 2 mg of extended-release melatonin every night for 8 weeks to 46 migraine sufferers. All 46 received also received 8 weeks of placebo in a double-blind crossover trial. Migraine frequency did improve from an average of 4.2 a month to 2.8 in both the melatonin and the placebo groups.

Another blinded trial was done in Brazil by Dr. Mario Peres and his colleagues. It compared 3 mg of immediate-release melatonin with a placebo and with 25 mg of amitriptyline. The study involved 196 patients. The number of headache days dropped by 2.7 days in the melatonin group, 2.18 for amitriptyline, and 1.18 for placebo. Melatonin significantly reduced headache frequency compared to placebo. Amitriptyline did not. Not surprisingly, melatonin was much better tolerated than amitriptyline. Considering its safety and very low cost, it is worth considering a trial of 3 mg of melatonin for the prevention of migraine headaches.

It is possible that, unlike with insomnia, a higher dose is more effective for the prevention of migraines. And, the immediate-release form could be more effective than the sustained-release one.

Melatonin may be effective as an acute treatment for pediatric migraine, according to a study just published by Dr. Amy Gelfand and her colleagues at UCSF. This was an 84-patient trial, although only 46 children completed it. Both low and high doses of melatonin were associated with pain reduction. Higher dose and napping after treatment predicted greater benefit. The benefit was likely an indirect one – melatonin helped children fall asleep and sleep, often in children but also in some adults, can relieve a migraine attack.

Nerivio is a smartphone-controlled wireless device that provides electrical stimulation of the type that is similar to TENS units widely used in physical therapy for musculoskeletal disorders. It was approved by the FDA last year for the treatment of acute migraines.

Nerivio was proven to be effective in a double-blind, sham-controlled study of 252 adults with migraine headaches. It was applied for 40 minutes on the upper arm and the strength of the current is gradually increased to a strong but non-painful intensity level. Active stimulation was more effective than sham stimulation in achieving pain relief (67% vs 39%), pain-free state (37% vs 18%), and relief of the most bothersome symptom such as nausea sensitivity to light or noise (46% vs 22%) at 2 hours post-treatment. The pain relief and pain-free superiority of the active treatment was sustained 48 hours post-treatment. The device was very well tolerated with only a few patients reporting local irritation.

This device is controlled by a smartphone which allows the manufacturer to collect data about its use (with patients’ permission and without identifying individual patients). After 6 months of my prescribing this device to a couple of hundred of patients, 62% of my patients reported having pain relief after 2 hours and 24% reported to be pain free after 2 hours. These numbers are comparable to the results seen with migraine drugs such as triptans (sumatriptan or Imitrex and other) as well as the new class of abortive migraine drugs, gepants (ubrogepant or Ubrelvy and rimegepant or Nurtec ODT). One big advantage of Nerivio is that it is not ingested and is much less likely to cause any side effects.

Theranica, the manufacturer of Nerivio is working to expand the indications for the device by conducting trials in adolescents and patients with chronic migraines.

Nerivio is not covered by most insurance companies and costs $99 for each disposable device which provides 12 treatments. It is available only by prescription. If you have difficulty finding a headache specialist, since the start of the pandemic we have begun to offer telemedicine visits using HIPAA-compliant platform. You can call our front desk (212-794-3550) to schedule an appointment.