Intervention: Modafinil
Trial phase: Phase 4
ATC code: N06BA07 | N06BA13
SMILES: NC(=O)CS(=O)C(c1ccccc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 184
Group description: At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
Eligibility criteria:
Inclusion Criteria:

The patient currently meets the criteria for Shift Work Disorder (SWD) for duration of at least 1 month.
The patient has the presence of excessive sleepiness late in the shift, including the commute home if applicable, with a Clinical Global Impression of Severity of Illness (CGI-S) rating of 4 or more at screening.
The patient has clinically significant difficulty in social or occupational functioning, with a Global Assessment of Function (GAF) score less than 70 (on clinician interview) at screening.
The patient has a Karolinska Sleepiness Scale (KSS) score of 6 or more at screening (visit 1) that is confirmed at baseline (visit 2).
The patient works at least 5 night shifts per month, of which at least 3 nights are consecutive, and plans to maintain this schedule.
The patient works night shifts or rotating shifts that include at least 6 hours between 2200 and 0800 (including the time period 0400 to 0800), and shifts are no longer than 12 hours in duration.
The patient is in good health, as judged by the investigator.
The patient is able to complete self-rating scales.
Women of childbearing potential (not surgically sterile or 2 years postmenopausal), must use a medically accepted method of contraception, and must continue use of 1 of these methods for the duration of the study (and for 30 days after participation in the study). Acceptable methods of contraception include: abstinence, barrier method with spermicide, steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method, or intrauterine device (IUD).
The patient is willing and able to comply with study restrictions and to attend regularly scheduled clinic visits as specified in this protocol

Exclusion Criteria:

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).
The patient has a medical or psychiatric disorder causing clinically significant functional impairment or contributing to the patient's excessive sleepiness.
The patient is currently taking a medication or substance that is causing clinically significant functional impairment or contributing to the patient's excessive sleepiness.
The patient has a clinically significant treated or untreated medical condition.
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.
The patient has a known hypersensitivity to armodafinil, racemic modafinil, or any component of the study drug tablets.
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.
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.
The patient uses any prescription or over-the-counter (OTC) drugs disallowed by the protocol within 30 days of the baseline visit.
The patient has been in a prior armodafinil study.
The patient has a history of alcohol, narcotic, or any other drug abuse.
The patient has a positive urine drug screen (UDS) without medical explanation at the screening visit.
The patient has a clinically significant deviation from normal on physical examination.
The patient is a pregnant or lactating woman.
The patient has used an investigational drug within 1 month of the screening visit.
The patient has a disorder that could interfere with the absorption, distribution, metabolism, or excretion of the investigational product.
The patient needs to use any of the excluded medications in this protocol.