Armodafinil

Indications

Armodafinil is used for: Narcolepsy, Obstructive sleep apnoea, Shift Work Sleep Disorder

Adult Dose

Oral Narcolepsy, Obstructive sleep apnoea Adult: 150-250 mg daily as a single dose in the morning or in 2 divided doses (in the morning and at midday). Shift Work Sleep Disorder 150 mg PO qDay 1 hour prior to patient's work shift Elderly: Consider lower initial dose Hepatic impairment: Reduce dose

Child Dose

Safety and efficacy not established

Renal Dose

Renal impairment: Safety and efficacy not established

Administration

May be taken with or without food.

Contra Indications

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.

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. Lactation: Unknown if excreted in milk; use caution

Pregnancy-Lactation

Pregnancy Limited available data in pregnant women are insufficient to inform about drug associated risk of adverse pregnancy outcomes; intrauterine growth restriction and spontaneous abortion reported in association with armodafinil and modafinil; although the pharmacology of armodafinil not identical to that of sympathomimetic amines, armodafinil shares some pharmacologic properties with this class; sympathomimetics have been associated with intrauterine growth restriction and spontaneous abortions Effectiveness of hormonal contraceptives may be reduced up to for one month after discontinuation of therapy; advise women who using a hormonal method of contraception to use additional barrier method or alternative non-hormonal method of contraception during treatment and for one month after discontinuation of treatment Lactation There are no data on presence of armodafinil or metabolite in human milk, effects on breastfed infant, or effect of this drug on milk production; modafinil was present in rat milk when animals were dosed during the lactation period; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for armodafinil and any potential adverse effects on breastfed child from armodafinil or from underlying maternal condition

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.

Adverse Effects

Side effects of Armodafinil : >10% Headache (14-23%) 1-10% Nausea (6-9%), Dry mouth (2-7%), Dizziness (5%), Anxiety (4%), Diarrhea (4%), Insomnia (4%), Rash (1-4%), Depression (1-3%), Dyspepsia (2%), Fatigue (2%), Palpitations (2%), Agitation (1%), Anorexia (1%), Attention disturbances (1%), Contact dermatitis (1%), Dyspnea (1%), Hyperhidrosis (1%), Nervousness (1%), Paresthesia (1%), Pyrexia (1%) <1% Angioedema, Dysphagia, Bronchospasm, Reversible psychosis

Mechanism of Action

The mechanism of armodafinil is unknown but it appears to exert its stimulant effects by reducing GABA-mediated neurotransmission.