Nefazodone

DEA Class;  Rx

Common Brand Names; Serzone, Nefazodone 5HT2, Serzone 5HT2

Co-administration with terfenadine (discontinued), astemizole (discontinued), cisapride, pimozide, carbamazepine

Concurrent administration with triazolam (75% dose reduction may be needed but not all commercially available dosage forms of triazolam may permit sufficient dosage reduction)

Hypersensitivity to nefazadone or other phenylpiperazine antidepressants

Co-administration with MAO inhibitors or within 14 days of administration

Liver injury resulting from previous nefazodone treatment

• Headache (31-35%)
• Somnolence (21-25%)
• Nausea (21-25%)
• Xerostomia (21-25%)
• Dizziness (15-20%)
• Asthenia (11-15%)
• Constipation (11-15%)
• Insomnia (11-15%)
• Infection (6-10%)
• Dyspepsia (6-10%)
• Lightheadedness (6-10%)
• Confusion (6-10%)
• Blurred vision (6-10%)
• Abnormal vision (6-10%)
• Increased appetite (1-5%)
• Memory loss (1-5%)
• Paresthesia (1-5%)
• Vasodilation (1-5%)
• Decreased concentration (1-5%)
• Ataxia (1-5%)
• Decreased libido (1-5%)
• Breast pain (1-5%)
• Decreased hematocrit (1-5%)
• Agitation with discontinuation (1-5%)
• Orthostatic hypotension (2.6%)
• Bradycardia (1.5%)
• Hypomania
• Mania
• Seizure
• Suicidal thoughts
• Suicide
• Worsening depression
• Liver failure (rare, 1 in 250,000-300,000)

Clinical worsening & suicide ideation may occur despite medication in adolescents & young adults (18-24 yo)

May take several weeks to achieve full response

May cause anticholinergic effects

Use caution in patients experiencing xerostomia, visual problems, paralytic ileus, BPH, urinary retention, or decreased motility

The pupillary dilation that occurs following use of many antidepressant drugs may trigger an angle-closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy

Postural hypotension reported; the prescriber should be aware that there is some risk of postural hypotension in association with this therapy; it should be used with caution in patients with known cardiovascular or cerebrovascular disease that could be exacerbated by hypotension (history of myocardial infarction, angina, or ischemic stroke) and conditions that would predispose patients to hypotension (dehydration, hypovolemia, and treatment with antihypertensive medication)

Rare occurrences of convulsions (including grand mal seizures) following administration of this drug reported since market introduction; a causal relationship has not been established

While priapism did not occur during premarketing experience, rare reports of priapism have been received since market introduction; a causal relationship to this drug has not been established; if patients present with prolonged or inappropriate erections, they should discontinue therapy immediately and consult their physicians; if the condition persists for more than 24 hours, a urologist should be consulted to determine appropriate management

Sinus bradycardia, defined as heart rate ≤ 50 bpm and a decrease of at least 15 bpm from baseline, reported with therapy; because patients with a recent history of myocardial infarction or unstable heart disease were excluded from clinical trials, such patients should be treated with caution

There are no adequate and well-controlled studies in pregnant women; therapy should be administered during pregnancy only if potential benefit justifies potential risk to fetus

Not known whether nefazodone or its metabolites are excreted in human milk; because many drugs are excreted in human milk, caution should be exercised when this drug is administered to a nursing woman