Armoda150

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

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

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