MODAFINIL (modafinil)

There are 1 contraindications. Absolute contraindication.

Contraindication List
Pregnancy

There are 10 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Acute myocardial infarction
Depression
Left ventricular hypertrophy
Manic disorder
Mitral valve prolapse
Myocardial ischemia
Psychotic disorder
Severe hepatic disease
Suicidal ideation
Unstable angina pectoris

There are 3 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Aggressive behavior
Hypertension
Severe renal impairment

There are 43 severe adverse reactions.

More Frequent	Less Frequent
None.	Acute cognitive impairment Cardiac arrhythmia Depression Dyskinesia Fever Hyperglycemia Hypertension Hypotension Memory impairment Mood changes Pharyngitis Tachycardia Toxic amblyopia Urinary retention Visual changes

Rare/Very Rare

Abnormal desquamation Abnormal ECG Abnormal hepatic function tests Agranulocytosis Anaphylaxis Angioedema Asthma Asystole Blistering skin Delusional disorder DRESS syndrome Dyspnea Edema Eosinophilia Hematuria Hepatitis Hyperkinesis Leukopenia Manic disorder Myocarditis Psychiatric disorder Skin rash Stevens-johnson syndrome Stomatitis Suicidal ideation Thrombocytopenic disorder Toxic epidermal necrolysis Urticaria

There are 32 less severe adverse reactions.

More Frequent	Less Frequent
Back pain Diarrhea Dizziness Dyspepsia Headache disorder Insomnia Nausea Nervousness Rhinitis Symptoms of anxiety	Anorexia Chest pain Chills Constipation Flu-like symptoms Hypertonia Neck stiffness Palpitations Paresthesia Polydipsia Tremor Vasodilation of blood vessels Vomiting Xerostomia

Rare/Very Rare
Aggressive behavior Agitation Dysgeusia Euphoria Flatulence General weakness Hyperhidrosis Pruritus of skin

A pregnancy registry is available that monitors pregnancy outcomes in women exposed to modafinil during pregnancy. Clinicians are encouraged to register patients, or pregnant patients can register themselves by calling 1-866-404-4106. Limited data are available to assess the drug-associated risk of adverse developmental outcomes with modafinil use during pregnancy; however, modafinil has been associated with intrauterine growth restriction and spontaneous abortion. Animal reproductive studies with modafinil in rats and rabbits during the period of organogenesis showed evidence of developmental toxicity (increased embryofetal and offspring mortality, decreased fetal growth) at clinically relevant plasma concentrations.

It is not known whether modafinil or its metabolites are distributed into human milk. Caution should be exercised when modafinil is used in nursing women.

Precaution Exists
Precaution exists. (No data or inconclusive human data.) Use of this drug by breast feeding mothers should be evaluated carefully.

Drug Name	Excretion Potential	Effect on Infant	Notes
Modafinil	Unknown. It is unknown whether the drug is excreted in human breast milk.	It is not known whether this drug has an adverse effect on the nursing infant. (No data or inconclusive human data)	Insufficient data available; molecular wt low enough for possible excretion

Clinical trial data from a small number of patients older than 65 years of age who received modafinil showed rates of adverse reactions comparable to those observed in younger age groups. However, age-related declines may reduce the clearance of modafinil and its metabolites in elderly patients. As a result, lower dosing and careful monitoring should be considered in this population.

Precaution Exists
Geriatric management or monitoring precaution exists.

Drug Name	Narrative	REN	HEP	CARDIO	NEURO	PULM	ENDO
Modafinil	General-Decreased clearance in the elderly. Use lower doses. Cardiovascular-Caution with underlying cardiovascular disease. Neuro/Psych-Avoid use in patients with insomnia.	N	Y	Y	Y	N	N