Armoda

• Obstructive sleep apnea (OSA) - to improve wakefulness in adults
• Narcolepsy - to improve wakefulness in adults
• Shift work disorder (SWD) - to improve wakefulness in adults

Armodafinil is an indirect dopamine receptor agonist. This is the R-enantiomer of Modafinil which is a 1:1 mixture of the R- and S-enantiomers.

Armodafinil binds to the dopamine transporter and inhibits dopamine reuptake. As a result, it increases neuronal activity in the hypothalamus and enhances activity in hypothalamic wakefulness center (TMN, tuberomammillary nucleus) within the hypothalamic sleep wake switch.

Adults:

• Obstructive Sleep Apnea & Narcolepsy: 150-250 mg as a single dose in the morning
• Shift Work Disorder: 150 mg as a single dose approximately 1 hour prior to the start of work shift

Elderly: Consider lower initial dose (elimination may be reduced due to aging)

Hepatic Impairment: Reduce dose in severe hepatic impairment

Renal Impairment: Safety and efficacy not established in severe renal impairment

Children: Safety and efficacy not established in patients <17 years

• Headache
• Dizziness
• Nausea
• Insomnia (difficulty in sleeping)
• Excitation or agitation

Serious Rare:

• Stevens-Johnson syndrome
• Angioedema and anaphylactic reactions
• Multi-organ hypersensitivity reactions
• Psychiatric symptoms
• Cardiovascular events

[CONSULT YOUR DOCTOR] Armodafinil may be unsafe to use during pregnancy (Pregnancy Category C). Animal studies have shown harmful effects on the developing baby. Your doctor will weigh the benefits and potential risks before prescribing. Use only if potential benefit justifies the potential risk to the fetus.

Serious Precautions:

• Patients should be cautioned about operating automobiles or hazardous machinery until reasonably certain that therapy will not adversely affect ability
• Caution in patients with history of psychosis, depression or mania - consider discontinuation if psychiatric symptoms develop
• Monitor heart rate and blood pressure - caution in cardiovascular disease
• Do not use in uncontrolled moderate to severe hypertension or cardiac arrhythmias
• May reduce effectiveness of contraceptive pills - use additional contraception methods
• Inform doctor if you develop suicidal thoughts, mood changes, rash, itching, or breathing problems
• Long-term use may have addiction/dependence potential
• Do not stop suddenly without consulting your doctor
• Not a replacement for a good sleep routine

There were no overdoses reported in clinical studies. Symptoms of overdose are likely similar to Modafinil - excitation or agitation, insomnia, and slight elevations in hemodynamic parameters. No specific antidote. Manage with primary supportive care.

Keep below 25°C, away from light & moisture. Keep out of reach of children.