Modafinil 200 mg (Modacare 200)

Product Overview Modafinil 200 mg is a prescription wakefulness-promoting agent (eugeroic). It is primarily used to treat excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA, as an adjunct to CPAP), and shift work sleep disorder (SWD). Modafinil promotes wakefulness by affecting certain chemicals in the brain (including dopamine), though its exact mechanism is not fully understood.

Important Warning Modafinil is a Schedule IV controlled substance with potential for abuse, misuse, dependence, and diversion, though the risk is low compared to other stimulants. Serious skin reactions (e.g., Stevens-Johnson syndrome), psychiatric symptoms (e.g., anxiety, aggression, hallucinations), and multi-organ hypersensitivity reactions can occur—stop use and seek immediate help if rash, fever, or swelling develops. May increase risk of suicidal thoughts; monitor mood changes. Hormonal contraceptives may be less effective during treatment and for 1 month after—use alternative birth control. Always follow your doctor’s instructions precisely.

Dosage and Administration

• Narcolepsy or OSA:200 mg once daily in the morning.
• Shift work sleep disorder:200 mg once daily, taken approximately 1 hour before the start of the work shift.
• Doses up to 400 mg/day have been used but provide no additional benefit over 200 mg.
• Elderly or patients with severe hepatic impairment: Consider lower dose (e.g., 100 mg/day).
• Renal impairment: No major adjustment needed, but use caution.
• Take with or without food. Swallow whole.
• Not approved for use in children under 17 years.

Common Side Effects

• Headache or nausea
• Nervousness, anxiety, or insomnia
• Dizziness or dry mouth
• Back pain or diarrhea

Serious side effects (seek immediate medical help): Severe rash/blisters, chest pain, irregular heartbeat, mood changes (e.g., depression, hallucinations), swelling (face/throat), or difficulty breathing.

Precautions and Contraindications

• Do not use if you have: Known hypersensitivity to modafinil or armodafinil.
• Use caution in patients with history of psychiatric disorders, cardiovascular disease (e.g., hypertension, recent heart attack), left ventricular hypertrophy, or mitral valve prolapse.
• Avoid alcohol and other CNS stimulants/depressants.
• Not recommended during pregnancy (potential risk of congenital malformations; use effective contraception) or breastfeeding (passes into breast milk; limited data suggest low infant exposure but monitor closely or avoid).
• May impair judgment, thinking, or motor skills—do not drive or operate machinery until you know how it affects you.
• Monitor blood pressure and heart rate regularly.

Storage Store at room temperature (20–25°C) in a cool, dry place away from light and moisture. Keep out of reach of children due to abuse potential.

Note: This information is for general guidance. Always consult your doctor or pharmacist for personalized advice, and read the patient information leaflet provided with your medication. Modafinil should only be used when prescribed.