Contraindications
Modafinil should NOT be used in the following situations:
Known Hypersensitivity
History of allergic reactions to modafinil, armodafinil, or any component of the formulation. This includes previous skin reactions, rashes, or other allergic symptoms.
Severe Cardiovascular Disease
Left ventricular hypertrophy, mitral valve prolapse with cardiac symptoms, recent myocardial infarction, unstable angina, or uncontrolled hypertension.
Certain Psychiatric Conditions
Active psychosis, severe anxiety disorders, or history of drug abuse (relative contraindication - requires careful evaluation).
Warnings and Precautions
🔴 Serious Skin Reactions
Risk: Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN)
- Typically occur within 1-5 weeks of treatment initiation
- May be life-threatening
- Discontinue immediately if skin rash occurs
- Do not restart modafinil after SJS/TEN
Signs to watch for: Skin rash, blisters, peeling, fever, sore throat
💓 Cardiovascular Effects
Monitoring required for:
- Blood pressure and heart rate increases
- Chest pain or palpitations
- ECG changes in patients with heart conditions
- Hypertension (may require dose reduction or discontinuation)
🧠 Psychiatric Symptoms
May cause or worsen:
- Depression, anxiety, or suicidal thoughts
- Mania or hypomania (especially in bipolar disorder)
- Psychosis, hallucinations, or delusions
- Aggression or hostility
Action: Discontinue if psychiatric symptoms develop
🤰 Pregnancy and Reproductive Health
Pregnancy Category C:
- Use only if benefit outweighs risk
- May cause fetal harm
- Pregnancy registry available for data collection
Contraception: Hormonal contraceptives may be less effective
Special Populations
👴 Elderly Patients
- Start with lower doses
- Monitor for increased sensitivity
- Consider reduced clearance
- Watch for drug interactions
👶 Pediatric Use
- Safety not established in children
- Higher risk of serious skin reactions
- Growth effects unknown
- Psychiatric symptoms more common
🤱 Nursing Mothers
- Unknown if modafinil enters breast milk
- Potential for serious adverse reactions in infants
- Consider discontinuing nursing or drug
- Weigh benefits vs. risks
🏥 Hepatic Impairment
- Reduce dose by 50% in moderate impairment
- Use extreme caution in severe impairment
- Monitor liver function
- Consider alternative therapy
Monitoring Requirements
Before Starting Treatment
- Complete medical history and physical exam
- Blood pressure and heart rate
- ECG if cardiovascular disease present
- Psychiatric evaluation if indicated
- Liver function tests
During Treatment
- Regular blood pressure monitoring
- Watch for skin reactions
- Monitor for psychiatric symptoms
- Assess sleep patterns
- Evaluate treatment effectiveness
Long-term Use
- Periodic cardiovascular assessment
- Liver function monitoring
- Psychiatric status evaluation
- Reassess need for continued therapy
- Monitor for tolerance or dependence
Safety Guidelines
🚗 Driving and Operating Machinery
- May cause dizziness or blurred vision
- Assess individual response before driving
- Be cautious with complex tasks requiring alertness
- Avoid alcohol while taking modafinil
💊 Medication Management
- Take exactly as prescribed
- Don't share with others
- Store at room temperature
- Keep in original container
- Dispose of unused medication properly
🏥 Medical Procedures
- Inform all healthcare providers about modafinil use
- May need to discontinue before surgery
- Can affect anesthesia requirements
- May interact with emergency medications