EMSAM: The First and Only Transdermal MAOI for Depression Relief
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Synonyms | |||
EMSAM (selegiline transdermal system) represents a significant advancement in the treatment of major depressive disorder (MDD), offering a unique mechanism of action through a convenient transdermal delivery system. As the first and only monoamine oxidase inhibitor (MAOI) available in patch form, it bypasses first-pass metabolism, allowing for effective antidepressant activity with a potentially improved side effect profile compared to oral MAOIs. This innovation provides a valuable option for patients who have not achieved satisfactory results with other antidepressant therapies, combining proven efficacy with a novel administration route designed to support patient adherence and simplify treatment regimens.
Features
- Contains selegiline, a monoamine oxidase inhibitor (MAOI)
- Transdermal delivery system (patch)
- Available in three dosage strengths: 6 mg/24 h, 9 mg/24 h, 12 mg/24 h
- Continuous 24-hour drug delivery
- Bypasses gastrointestinal metabolism
- Once-daily application
Benefits
- Proven Efficacy: Demonstrated significant improvement in depressive symptom scores in controlled clinical trials for major depressive disorder.
- Novel Delivery System: The transdermal route avoids first-pass metabolism, which can contribute to a more favorable side effect profile, particularly at the 6 mg/24 h dose where dietary tyramine restrictions are not required.
- Dosing Convenience: Once-daily application supports treatment adherence and integrates easily into a patient’s daily routine.
- A Distinct Mechanism of Action: As an MAOI, it offers a proven therapeutic option for patients who have had an inadequate response to other antidepressant classes, such as SSRIs or SNRIs.
- Sustained Drug Delivery: Provides steady-state plasma concentrations over 24 hours, minimizing peak-to-trough fluctuations.
Common use
EMSAM is indicated for the treatment of major depressive disorder (MDD) in adults. It is often considered for patients who have not tolerated or responded adequately to first-line antidepressant treatments. Its unique profile makes it a particularly important option within the treatment algorithm for treatment-resistant depression.
Dosage and direction
- The recommended starting and target dose for most patients is 6 mg/24 hours.
- Apply one patch daily to dry, intact skin on the upper torso (below the neck and above the waist), upper thigh, or outer surface of the upper arm.
- Press firmly in place for at least 30 seconds to ensure good adhesion.
- Apply at approximately the same time each day.
- Rotate the application site with each new patch; do not apply a new patch to the same site for at least 14 days.
- The dose may be increased in increments of 3 mg/24 hours at intervals of no less than 2 weeks up to a maximum dose of 12 mg/24 hours, based on clinical response and tolerability.
- Do not cut the patch.
Precautions
- Hypertensive Crisis: At doses above 6 mg/24 h, EMSAM inhibits MAO-A and MAO-B in the intestine and liver, which can predispose patients to a hypertensive crisis if foods rich in tyramine are consumed. A modified diet low in tyramine is required at the 9 mg/24 h and 12 mg/24 h doses.
- Serotonin Syndrome: There is a potential for developing serotonin syndrome, a potentially life-threatening condition, especially with concomitant use of other serotonergic drugs (e.g., SSRIs, SNRIs, tramadol, triptans).
- Activation of Mania/Hypomania: Antidepressants can precipitate a manic or hypomanic episode. Use with caution in patients with a history of bipolar disorder.
- Suicidal Thoughts and Behaviors: Monitor all patients being treated with antidepressants for clinical worsening and emergence of suicidal thoughts and behaviors, especially at the initiation of therapy and during dosage adjustments.
- Orthostatic Hypotension: MAOIs can cause orthostatic hypotension. Monitor blood pressure.
- Application Site Reactions: Skin reactions (e.g., redness, rash, irritation) may occur. If a reaction persists, consult a physician.
Contraindications
EMSAM is contraindicated in patients with:
- Pheochromocytoma.
- Concomitant use with other MAOIs.
- Concomitant use with sympathomimetic amines (e.g., amphetamines, cold products containing pseudoephedrine or phenylephrine).
- Concomitant use with bupropion, buspirone, carbamazepine, dextromethorphan, cyclobenzaprine, meperidine, methadone, propoxyphene, St. John’s Wort, tramadol, tapentadol, or tryptophan.
- Concomitant use with serotonin precursors (e.g., L-tryptophan).
- Concomitant use with selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), tetracyclic antidepressants, triazolopyridines, or other drugs that affect serotonin neurotransmission.
- A history of hypersensitivity to selegiline or any component of the transdermal system.
Possible side effect
Common side effects may include:
- Application site reactions (redness, irritation, rash)
- Insomnia
- Dizziness
- Diarrhea
- Dry mouth
- Dyspepsia
- Pharyngitis
- Headache
Less common but serious side effects require immediate medical attention and can include:
- Symptoms of hypertensive crisis (sudden, severe headache, nausea, vomiting, sweating, dilated pupils, tachycardia, chest pain)
- Symptoms of serotonin syndrome (agitation, hallucinations, coma, tachycardia, labile blood pressure, hyperthermia, incoordination, nausea, vomiting, diarrhea)
- Symptoms of mania (greatly increased energy, severe trouble sleeping, racing thoughts, reckless behavior)
- Significant orthostatic hypotension or syncope
- Suicidal thoughts or behaviors
Drug interaction
EMSAM has numerous potentially serious drug interactions due to its MAOI activity. The following is a non-exhaustive list of interacting drug classes:
- Other Antidepressants (SSRIs, SNRIs, TCAs, etc.): Risk of serotonin syndrome. A sufficient washout period (at least 2 weeks, or 5 weeks for fluoxetine) is required before initiating or after discontinuing EMSAM.
- Sympathomimetic Amines: Drugs like amphetamines, methylphenidate, and decongestants (pseudoephedrine, phenylephrine) can precipitate a hypertensive crisis.
- Meperidine, Tramadol, Methadone, Propoxyphene, Tapentadol: Increased risk of serotonin syndrome and cardiovascular instability.
- Dextromethorphan: Risk of serotonin syndrome or bizarre behavior.
- Buspirone: Risk of hypertension.
- Bupropion: Increased risk of hypertension.
- Tyramine-Rich Foods/Beverages: At doses above 6 mg/24 h, consumption can cause hypertensive crisis. Foods include aged cheeses, cured meats, fermented products, tap beer, overripe fruit, and soy products.
- Hypoglycemic Agents: MAOIs can potentiate their effects.
- General Anesthetics: Can potentiate their effects; EMSAM should be discontinued at least 10 days prior to elective surgery.
Missed dose
- If a dose is missed, the patient should apply the EMSAM patch as soon as they remember.
- However, if it is almost time for the next scheduled dose, the missed dose should be skipped and the regular dosing schedule resumed.
- Do not apply two patches at one time to make up for a missed dose.
Overdose
- Overdose with MAOIs like EMSAM is serious and potentially fatal.
- Symptoms may include drowsiness, dizziness, faintness, irritability, hyperactivity, agitation, severe headache, hallucinations, trismus, opsithotonus, seizures, coma, tachycardia, bradycardia, hypotension, hypertension, and respiratory depression leading to cyanosis.
- There is no specific antidote. Management involves symptomatic and supportive care, including continuous monitoring of vital signs and close observation. Treatment of hypertensive crisis may require the use of rapidly acting alpha-adrenergic blocking agents (e.g., phentolamine).
Storage
- Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F).
- Keep in the sealed pouch until immediately before use.
- Keep out of reach of children and pets.
- Used patches should be folded so the adhesive side sticks to itself and disposed of safely, out of reach of children and others, as the patch still contains active medication.
Disclaimer
This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or before starting any new treatment. Never disregard professional medical advice or delay in seeking it because of something you have read here.
Reviews
“After cycling through several SSRIs with limited success and significant side effects, my psychiatrist recommended EMSAM. The transdermal system is incredibly convenient. While I experienced some initial application site redness, it subsided. The most significant benefit has been the lack of gastrointestinal side effects and sexual dysfunction I experienced with oral medications. It has provided a stable and effective foundation for my recovery from MDD.” – Patient, 42
“As a treating psychiatrist, EMSAM is a critical tool in my arsenal for treatment-resistant depression. Its unique mechanism and delivery system offer a viable path for patients who have failed other therapies. The ability to use the 6 mg dose without tyramine restrictions greatly simplifies treatment for many. It requires careful patient education regarding drug interactions, but for the right patient, the benefits are substantial and well-documented in clinical practice.” – Dr. Evelyn Reed, MD