Concise Prescribing Info
Listed in Dosage.
Dosage/Direction for Use
Adult: PO Narcolepsy; Obstructive sleep apnoea Initial: 200 mg daily as single dose in the morning or in 2 divided doses in the morning and at noon. Doses up to 400 mg daily in 1 or in 2 divided doses may be given if response is insufficient. Shift-work sleep disorder 200 mg daily as single dose approx 1 hour prior to start of work shift.
May be taken with or without food.
Uncontrolled moderate to severe hypertension, cardiac arrhythmias.
Special Precautions
Patients with history of psychiatric disorders (e.g. psychosis, depression, mania, major anxiety, agitation, insomnia), alcohol, drug or illicit substance abuse; CV disease (e.g. recent history of MI, unstable angina, coronary artery disease). Severe hepatic or renal impairment. Elderly. Pregnancy and lactation. Not recommended in patients with a history of left ventricular hypertrophy or cor pulmonale, and in patients with mitral valve prolapse induced by previous CNS stimulant use. Patient Counselling This drug may cause blurred vision or dizziness, if affected, do not drive or operate machinery. Monitoring Parameters Perform ECG before initiation of therapy. Monitor blood pressure, heart rate, development of severe skin reactions or psychiatric symptoms.
Adverse Reactions
Significant: Onset or worsening of anxiety, nervousness, insomnia, confusion, agitation, depression, suicide-related behaviour, psychotic or manic symptoms, aggressive or hostile behaviour. Cardiac disorders: Tachycardia, palpitation, chest pain. Eye disorders: Blurred vision. Gastrointestinal disorders: Abdominal pain, nausea, dry mouth, diarrhoea, dyspepsia, constipation. General disorders and administration site conditions: Back pain. Immune system disorders: Angioedema. Investigations: Abnormal liver function test. Metabolism and nutrition disorders: Decreased appetite. Nervous system disorders: Headache, dizziness, paraesthesia. Psychiatric disorders: Hallucinations, delusions, somnolence. Respiratory, thoracic and mediastinal disorders: Rhinitis, pharyngitis. Vascular disorders: Vasodilation, hypertension.
Potentially Fatal: Rarely, multi-organ hypersensitivity reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms.
Drug Interactions
Altered plasma concentrations with CYP3A4 inducers (e.g. carbamazepine, phenobarbital, rifampicin) and CYP3A4 inhibitors (e.g. ketoconazole, itraconazole). Decreased clearance of phenytoin, warfarin, diazepam, propranolol, omeprazole. Reduced effectiveness of steroidal contraceptives.
ATC Classification
N06BA07 - modafinil ; Belongs to the class of centrally-acting sympathomimetics. Used as CNS stimulant.
Disclaimer: This information is independently developed by CIMS based on modafinil from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 CIMS. All rights reserved. Powered by
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