Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults.

1 mg white to off-white tablets, capsule shaped, film-coated, and debossed with "N" on one side and "1" on the other side

2.5 mg green tablets, capsule shaped, film-coated, and debossed with "N" on one side and "2.5" on the other side

Naratriptan tablets are contraindicated in patients with:

The following adverse reactions are discussed in more detail in other sections of the prescribing information:

Adverse reactions observed after overdoses of up to 25 mg included increases in blood pressure resulting in lightheadedness, neck tension, tiredness, and loss of coordination. Also, ischemic ECG changes likely due to coronary artery vasospasm have been reported.

The elimination half-life of naratriptan is about 6 hours

Naratriptan tablets, USP contain naratriptan hydrochloride USP, a selective 5-HT

The empirical formula is C

Each naratriptan tablet, USP for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride USP, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, anhydrous lactose, magnesium stearate, microcrystalline cellulose, opadry white (1 mg tablet) and opadry green (2.5 mg tablet). The components of opadry white are hypromellose, triacetin, and titanium dioxide. The components of opadry green are hypromellose, triacetin, titanium dioxide, iron oxide yellow, and FD&C Blue No. 2.

The efficacy of naratriptan tablets in the acute treatment of migraine headaches was evaluated in 3 randomized, double-blind, placebo-controlled trials in adult patients (Trials 1, 2, 3). These trials enrolled adult patients who were predominantly female (86%) and Caucasian (96%) with a mean age of 41 years (range: 18 to 65 years). In all studies, patients were instructed to treat at least 1 moderate to severe headache. Headache response, defined as a reduction in headache severity from moderate or severe pain to mild or no pain, was assessed up to 4 hours after dosing. Associated symptoms such as nausea, vomiting, photophobia, and phonophobia were also assessed. Maintenance of response was assessed for up to 24 hours postdose. A second dose of naratriptan tablets or other rescue medication to treat migraines was allowed 4 to 24 hours after the initial treatment for recurrent headache.

In all 3 trials, the percentage of patients achieving headache response 4 hours after treatment, the primary outcome measure, was significantly greater among patients receiving naratriptan tablets compared with those who received placebo. In all trials, response to 2.5 mg was numerically greater than response to 1 mg and in the largest of the 3 trials, there was a statistically significant greater percentage of patients with headache response at 4 hours in the 2.5 mg group compared with the 1 mg group. The results are summarized in Table 2.

The estimated probability of achieving an initial headache response in adults over the 4 hours following treatment in pooled Trials 1, 2, and 3 is depicted in Figure 1.

For patients with migraine-associated nausea, photophobia, and phonophobia at baseline, there was a lower incidence of these symptoms 4 hours following administration of 1 mg and 2.5 mg naratriptan tablets compared with placebo.

Four to 24 hours following the initial dose of study treatment, patients were allowed to use additional treatment for pain relief in the form of a second dose of study treatment or other rescue medication. The estimated probability of patients taking a second dose or other rescue medication to treat migraine over the 24 hours following the initial dose of study treatment is summarized in Figure 2.

There is no evidence that doses of 5 mg provided a greater effect than 2.5 mg. There was no evidence to suggest that treatment with naratriptan tablets was associated with an increase in the severity or frequency of migraine attacks. The efficacy of naratriptan tablets was unaffected by presence of aura; gender, age, or weight of the subject; oral contraceptive use; or concomitant use of common migraine prophylactic drugs (e.g., beta-blockers, calcium channel blockers, tricyclic antidepressants). There was insufficient data to assess the impact of race on efficacy.

Naratriptan tablets, USP containing 1 mg and 2.5 mg of naratriptan (base) as the hydrochloride salt.

Naratriptan Tablets USP, 1 mg, are white to off-white colored, capsule shaped, film-coated tablets debossed with “N” on one side and “1” on the other side are supplied as:

Carton of 9 Unit-of-Use tablets each with  cross perforation and individually labeled NDC 69452-340-72

Naratriptan Tablets USP, 2.5 mg, are green colored, capsule shaped, film-coated tablets debossed with “N” on one side and “2.5” on the other side are supplied as:

Carton of 9 Unit-of-Use tablets each with cross perforation and individually labeled NDC 69452-341-72

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Inform patients that naratriptan tablets may cause serious cardiovascular side effects such as myocardial infarction or stroke. Although serious cardiovascular events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, irregular heartbeat, significant rise in blood pressure, weakness, and slurring of speech and should ask for medical advice if any indicative sign or symptoms are observed. Apprise patients of the importance of this follow-up

Inform patients that anaphylactic reactions have occurred in patients receiving naratriptan tablets. Such reactions can be life threatening or fatal. In general, anaphylactic reactions to drugs are more likely to occur in individuals with a history of sensitivity to multiple allergens

Inform patients that use of naratriptan tablets within 24 hours of another triptan or an ergot-type medication (including dihydroergotamine or methysergide) is contraindicated

Caution patients about the risk of serotonin syndrome with the use of naratriptan tablets or other triptans, particularly during combined use with SSRIs, SNRIs, TCAs, and MAO inhibitors

Inform patients that use of acute migraine drugs for 10 or more days per month may lead to an exacerbation of headache and encourage patients to record headache frequency and drug use (e.g., by keeping a headache diary)

Advise patients to notify their healthcare provider if they become pregnant during treatment or intend to become pregnant

Advise patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed [see Use in Specific Populations (8.2)].

Treatment with naratriptan tablets may cause somnolence and dizziness; instruct patients to evaluate their ability to perform complex tasks after administration of naratriptan tablets.