Modafinil

Registered South African indications:

• Excessive daytime sleepiness

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Uncontrolled moderate to severe hypertension 
• Patients with cardiac arrhythmias

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Severe hepatic impairment
• Elderly
• Children (<18 years)
• History of psychiatric disorders
• Major anxiety 
• Bipolar disorder
• Psychotic or manic symptoms
• Aggressive or hostile behaviour
• Insomnia
• Left ventricular hypertrophy
• Cor pulmonale 
• Mitral valve prolapse syndrome when previously receiving central nervous system stimulants
• Female patients of child bearing potential
• Patients using steroidal contraceptives
• History of substance abuse 
• Galactose intolerance
• Lapp lactase deficiency
• Glucose-galactose malabsorption
• May impair ability to drive and operate machinery

Forms avail. in SA and covered in this monograph: tab

Excessive daytime sleepiness associated with narcolepsy

• Oral (tab): 200-400mg, dly in the morning

---

Not established for use for longer than 9 weeks

Not established for use in children below 18 years

Pregnancy

• Caution
• There is limited data on the use of modafinil in pregnant women.  Studies in animals have shown reproductive toxicity 
• Modafinil is not recommended for use during pregnancy or in women of childbearing potential unless they are using effective contraception. As modafinil may reduce the effectiveness of oral contraception, alternative additional methods of contraception are required 

Breastfeeding

• Caution
• Available pharmacodynamic/toxicological data in animals have shown excretion of modafinil/metabolites in milk. Modafinil should not be used during breastfeeding

Renal Impairment

• Caution; no dose adjustment recommended

Hepatic Impairment

• Mild to moderate: No dose adjustment recommended
• Severe: Caution; dose adjustment recommended
  Reduce dose by 50%

Elderly

• Caution; dose adjustment recommended
  Commence dose at 100mg daily

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Prohibited - In competition

Central Nervous System Disorders

• Nervousness
• Insomnia
• Anxiety
• Depression
• Abnormal thinking
• Confusion
• Sleep disorder
• Emotional lability
• Decreased libido
• Hostility
• Depersonalisation
• Personality disorder
• Abnormal dreams
• Agitation
• Aggression
• Suicidal ideation
• Hallucinations
• Mania
• Psychosis
• Delusions
• Headache
• Dizziness
• Somnolence
• Paraesthesia
• Dyskinesia
• Hypertonia
• Hyperkinesia
• Amnesia
• Migraine
• Tremor
• Vertigo
• Central nervous system stimulation
• Hypoaesthesia
• Incoordination
• Movement disorder
• Speech disorder
• Taste perversion
• Asthenia

Cardiovascular Disorders

• Tachycardia
• Palpitation
• Extrasystoles
• Arrhythmia
• Bradycardia
• Vasodilatation
• Hypertension
• Hypotension
• Chest pain
• Abnormal ECG

Respiratory Disorders

• Dyspnoea
• Increased cough
• Asthma
• Epistaxis
• Rhinitis

Gastrointestinal Disorders

• Pharyngitis
• Sinusitis
• Abdominal pain
• Nausea and vomiting
• Dry mouth
• Diarrhoea
• Dyspepsia
• Constipation
• Flatulence
• Reflux
• Dysphagia
• Glossitis
• Mouth ulcers

Hepatobiliary Disorders

• Abnormal hepatic function tests
• Increase in alkaline phosphatase 
• Increase in gamma-glutamyltransferase

Genitourinary Disorders

• Abnormal urine
• Urinary frequency
• Menstrual disorder

Endocrine and Metabolic Disorders

• Decreased appetite
• Hypercholesterolaemia
• Hyperglycaemia
• Diabetes mellitus
• Increased appetite
• Thirst
• Weight change

Musculoskeletal Disorders

• Back pain
• Neck pain
• Myalgia
• Myasthenia
• Leg cramps
• Arthralgia
• Twitch

Skin and Subcutaneous Tissue Disorders

• Sweating
• Rash
• Acne
• Pruritis
• Serious skin reactions
• Erythema multiforme
• Stevens-Johnson syndrome 
• Toxic epidermal necrolysis
• Drug rash with eosinophilia and systemic symptoms 
• Peripheral oedema

Immune, Blood and Lymphatic System Disorders

• Eosinophilia
• Leucopenia
• Minor allergic reaction
• Angioedema
• Urticaria 
• Hypersensitivity reactions

Sensory Disorders

• Blurred vision
• Abnormal vision
• Dry eye

• CYP2C19 substrates 
• CYP3A4 substrates
• CYP3A5 substrates  
• CYP3A4 inducers
• CYP2C9 substrates
• CYP2D6 substrates
• Anticonvulsants
• Steroidal contraceptives
• Antidepressants
• Anticoagulants

• Vital signs
• Mental status

The mechanism through which modafinil promotes wakefulness is unknown. Modafinil has wake-promoting actions like sympathomimetic agents including amphetamine and methylphenidate, although the pharmacological profile is not identical to that of sympathomimetic amines.

Tablet 100mg

• Provigil (Acino) originator