Erman 2011.

Methods	Trial design: Randomized, double blind, placebo controlled, according to Guideline for Good Clinical Practice Country: USA Healthcare settings: 45 centres (insomnia research and treatment) Work settings: Shift workers 18 to 65 years, 25% health care sector, 15% protective services and 10% in transportation Randomisation procedure: Inclusion period: Feb to Oct 2010 Follow‐up: Six weeks
Participants	Inclusion: Regular shift workers (minimum five nights/month, minimum three consecutive nights) age 18 to 65 with excessive sleepiness associated with shift work sleep disorder (score > 4 in CGI‐C, < 7 in GAF and > 6 in average KSS scales) Number randomised: Screened 649, randomised 383, treated 371, followed‐up 313 Lost to follow‐up: Not started 12, discontinued 58 Age mean: Intervention 36.1, control 36.7 Sex: Intervention male 53%, control male 56% Exclusion: Obstructive sleep apnoea, medical or psychiatric disorder causing sleepiness; use of modafinil, caffeine > 600 mg/day, melatonin, amphetamine, sedating antidepressants or other medication causing sleepiness.
Interventions	Trial intervention: armodafinil 150 mg; 50 mg at first evening, 100 mg at second and third evening and 150 mg from fourth evening onwards. Comparison intervention: Placebo Treatment providers: Cephalon Inc pharmaceutical company Treatment frequency and duration: Once 30 to 60 minutes before night shift, latest at 11 o'clock; six weeks; four visits and one telephone call during the trial period.
Outcomes	Sleep length, sleep onset and quality while off work: Cognitive performance, sleepiness and fatigue at work: (during the last night of a shift period) Clinical global impression of Change ‐ Severity of illness (CGI‐C), Global assessment of Functioning (GAF), KSS in baseline and in weeks three and six.
Notes	Source of funding: Trial was sponsored by Cephalon (producer of armodafinil) Ethics: According to Quideliness of Good Clinical Practice Trial Registration: clinical trials.gov identifier NCT01080807 (tolerability)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Phase IV clinical trial, randomisation by protocol; trial according to Guideline for Good Clinical Practice; Trial register: clinical trials.gov identifier NCT01080807 Allocation: Randomized Endpoint classification: Safety/efficacy trial Intervention model: Parallel assignment Masking: Double blind (subject, caregiver, investigator, outcomes assessor) Primary Purpose: Treatment 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 six weeks. Trial 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 (one tablet), the second and third doses were 100 mg (two tablets), and the fourth and subsequent doses were 150 mg (three tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
Allocation concealment (selection bias)	Unclear risk	No description.
Blinding of participants All outcomes	Low risk	No description.
Blinding of care providers	Unclear risk	No description.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No description.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Withrawal less than 20% during the trial (88% completed in placebo group, 82% in armodafinil group; 9/184 adverse effects in armodafinil group). The efficacy analysis included 256 to 259 (90%) of 283 patients. The efficacy analysis used last‐observation‐carried‐forward method and used final visit (last recorded visit) in analysis. KSS had 256/283 observations (placebo 180/190, armodafinil 176/193) and Global Assessment of Function.
Outcome measured with validated instrument All outcomes	Low risk	KSS (secondary efficacy variable)(patient assessed) Clinical global impression of Change ‐ Seveity of illness (CGI‐C)(secondary efficacy variable)(investigator assessed) Global Assessment of Functioning (GAF) (primary efficacy variable)(investigator assessed).
Selective reporting (reporting bias)	Low risk	All outcomes reported as planned.
Other bias	Unclear risk	‐