Modafinil

Indications
 Oral
Narcolepsy
Adult: 200-400 mg daily as a single dose in the morning or in 2 divided doses (in the morning and at midday).
Elderly: Initially, 100 mg daily.
Renal impairment: Severe: Reduce total dose to 100-200 mg daily.
Hepatic impairment: Severe: Reduce total dose to 100-200 mg daily.
Oral
Obstructive sleep apnoea
Adult: 200-400 mg daily as a single dose in the morning or in 2 divided doses (in the morning and at midday).
Elderly: Initially, 100 mg daily.
Renal impairment: Severe: Reduce total dose to 100-200 mg daily.
Hepatic impairment: Severe: Reduce total dose to 100-200 mg daily.
Oral
Shift-work sleep disorder
Adult: 200 mg as a single dose 1 hr before starting work.

Special Populations: For severe liver or renal impairment, ½ the dose.
Contraindications
 Uncontrolled moderate to severe hypertension or cardiac arrhythmias; history of left ventricular hypertrophy or ischaemic ECG changes, chest pain, any clinical signs of mitral valve prolapse.
Warnings / Precautions
 History of psychosis, depression, mania. Discontinue use if there is any sign of rash or hypersensitivity reaction. Increase monitoring in patients with hypertension. Hepatic and renal impairment. Tourette's syndrome. May impair ability to drive or operate machinery. Pregnancy and lactation.
Adverse Reactions
 Headache, nervousness, insomnia, agitation, confusion, personality disorders, tremor, anxiety; GI disturbances; hypertension, palpitations, tachycardia; angioedema; psychosis, depression, mania, abnormal LFTs.
Potentially Fatal: Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis.
Overdose Reactions
 Symptoms: Agitation, irritability, aggressiveness, confusion, nervousness, tremor, insomnia, palpitations, elevations in haemodynamic parameters. Management: Symptomatic and supportive. Monitor cardiac function.
Drug Interactions
 May increase metabolism of ciclosporin, oral contraceptives. May increase the levels/effects of warfarin, TCAs and CYP2C19 substrates (e.g. citalopram, diazepam, methsuximide, phenytoin, propranolol, sertraline). Levels/effects may be reduced with CYP3A4 inducers (e.g. aminoglutethimide, carbamazepine, nafcillin, nevirapine, phenobarbital, phenytoin, rifamycins). Levels/effects may be increased with CYP3A4 inhibitors (e.g. azole antifungals, clarithromycin, diclofenac, doxycycline, erythromycin, imatinib, isoniazid, nefazodone, nicardipine, propofol, protease inhibitors, quinidine, telithromycin, verapamil). Avoid alcohol.
See Below for More modafinil Drug Interactions
Mechanism of Actions
 The mechanism of modafinil is unknown but it appears to exert its stimulant effects by reducing GABA-mediated neurotransmission.
Absorption: Well absorbed from the GI tract (oral); peak plasma concentrations after 2-4 hr.
Distribution: Protein-binding: Approx 60% (mainly to albumin).
Metabolism: Hepatic; partially by CYP3A4 and CYP3A5 isoenzymes. 2 major metabolites: Acid modafinil and modafinil sulfone (both inactive).
Excretion: Mainly via urine (<10% of the dose eliminated unchanged). Elimination half-life: 15 hr (after multiple doses).
Administration
 May be taken with or without food.
Storage Conditions
 Oral: Store at 20-25°C (68-77°F).
ATC Classification
 N06BA07 - modafinil ; Belongs to the class of centrally-acting sympathomimetics. Used as CNS stimulant.
Storage
 Oral: Store at 20-25°C (68-77°F).
Available As
  • Modafinil 100 mg
  • Modafinil 200 mg

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