Efficacy and Tolerability of Armodafinil in Adults With Excessive Sleepiness Associated With Shift Work Disorder

Exclusion Criteria

• •1. The patient has mild or more severe obstructive sleep apnea (OSA) defined as an apnea/hypopnea index more than 5 as determined by daytime polysomnography (PSG).
• •2. The patient has a medical or psychiatric disorder causing clinically significant functional impairment or contributing to the patient's excessive sleepiness.
• •3. The patient is currently taking a medication or substance that is causing clinically significant functional impairment or contributing to the patient's excessive sleepiness.
• •4. The patient has a clinically significant treated or untreated medical condition.
• •5. The patient has a history of clinically significant suicidal ideation in the judgment of the principal investigator or is currently suicidal based on medical and psychiatric history.
• •6. The patient has a known hypersensitivity to armodafinil, racemic modafinil, or any component of the study drug tablets.
• •7. The patient has a history of any clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction, including multiple allergies or drug reactions.
• •8. The patient consumes caffeine including coffee, tea and/or other caffeine containing beverages or food averaging more than 600 mg of caffeine per day within 7 days of the baseline visit.
• •9. The patient uses any prescription or over-the-counter (OTC) drugs disallowed by the protocol within 30 days of the baseline visit.
• •10. The patient has been in a prior armodafinil study.
• •11. The patient has a history of alcohol, narcotic, or any other drug abuse.
• •12. The patient has a positive urine drug screen (UDS) without medical explanation at the screening visit.
• •13. The patient has a clinically significant deviation from normal on physical examination.
• •14. The patient is a pregnant or lactating woman.
• •15. The patient has used an investigational drug within 1 month of the screening visit.
• •16. The patient has a disorder that could interfere with the absorption, distribution, metabolism, or excretion of the investigational product.
• •17. The patient needs to use any of the excluded medications in this protocol.