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Shift-work disorderfor a motor vehicle accident during the commute home.Practical steps are summarized in TABLE 2.Attention to dietOne study has suggested that attention to dietary compositionmay have an impact on alertness and performanceamong individuals working night shifts in ahospital setting. 44 The study suggested that a diet witha carbohydrate-to-protein ratio of around 3:1 is optimalin terms of benefits for both mood and psychometricperformance.Pharmacologic interventionsWakefulness-promoting agentsThe wakefulness-promoting agents modafinil and armodafinil(the R-enantiomer of modafinil) are currentlythe only agents specifically approved by the FDA forthe treatment of ES associated with SWD. Approval ofmodafinil for this indication was based on the resultsof 2 controlled clinical trials (TABLE 3). 45,46 Modafinil significantlyimproved wakefulness, as measured using patient-reporteddiary data and changes on the MultipleSleep Latency Test (P < .001 and P = .002, respectively) inthose who had ES as a consequence of SWD. 45 Attentionwas also significantly improved in the modafinil groupcompared with placebo (P < .001), and significantlyfewer participants treated with modafinil reported accidentsor near misses during the commute home thandid those who received placebo (P < .001). 45 Additionally,modafinil significantly improved self-reports of functioning(in terms of productivity and vigilance; P < .05)and quality of life (P < .05) in individuals with SWD. 46In these 2 studies, headache was the most commonlyreported adverse event, and nausea was thenext most prominent adverse effect with modafinil. Inthe study by Czeisler and colleagues 45 more modafiniltreatedpatients experienced insomnia compared withthe placebo group (6% vs 0%, respectively; P < .01).Armodafinil has been shown to improve wakefulnessin individuals with ES associated with SWD in acontrolled clinical trial (TABLE 3). 47,48 This study showedarmodafinil to be significantly better than placebo atimproving wakefulness, reflected by a significantly prolongedsleep latency throughout the night among nightshiftworkers with SWD (P < .0001). Compared withplacebo, treatment with a single dose of armodafinil150 mg, 30 to 60 minutes before the start of the shift, significantlyreduced ES at work (P < .0001) and during thecommute home (P = .0027) and did not adversely affectdaytime sleep. 47,48 As observed for modafinil, headacheand nausea were the most common treatment-emergentadverse events in patients with SWD who took partin these 2 studies.To date, no studies have been performed that directlycompare the efficacy of armodafinil and modafinil;however, the 2 wakefulness-promoting agents do havedifferent pharmacokinetic profiles. 49,50 Compared withmodafinil, armodafinil takes longer to reach its peakplasma concentration and is present at higher concentrationsfor a longer period after administration, resultingin its wakefulness-promoting effects lasting throughoutthe day. 49,50 The longer duration of armodafinil’s effectsand its potential for once-daily dosing make it an appropriateand convenient choice for patients with SWD.StimulantsStimulants, such as methamphetamine, have beenshown to enhance wakefulness in individuals undergoingsimulated night-shift work. 51,52 However, amphetaminescan induce rebound insomnia and this, combinedwith their adverse cardiovascular effects and theirabuse potential, makes them less than ideal options foran often chronic condition such as SWD. 53 Methamphetaminehas not been evaluated as an interventionfor individuals with a diagnosis of SWD and, althoughit is effective at improving performance and mood duringone or more night shifts after single doses, its usefulnessin managing SWD on numerous sequential nightsis questionable.A number of studies among individuals undergoingsimulated night-shift work suggest that caffeine may beuseful to promote wakefulness during the work period,although there may be some residual effects on daytimesleep depending on the caffeine drink selected. 54-56 Onestudy suggested that low-dose repeated caffeine administrationmay improve performance at the expenseof increasing subjective ES during periods of extendedwakefulness. 57 As discussed above, caffeine in combinationwith other wakefulness-promoting strategies,including scheduled napping and bright light therapy,has proved to be a promising intervention under simulatedshift-work conditions. 22,23 However, the appropriatedose and timing of caffeine intake to optimizeperformance and mood during a night shift have not yetbeen determined. Higher caffeine doses may induce astate of hyperstimulation and can even be toxic. 58 Moreover,habitual caffeine intake can lead to the developmentof tolerance to its effects, 59 abrogating the efficacyof caffeine intake in the long-term management of anoften chronic condition such as SWD. To date, regularS28 January 2010 / Vol 59, No 1 • Supplement to The Journal of Family Practice
Table 3 Improved wakefulness and reduced ES associated with FDA-approved wakefulness-promoting agents 45-48Citation Population RegimensModafinilN (evaluableefficacypopulation)Key findingsCzeisler et al 45 Adults (18-60years) withSWD working≥5 nightshifts/monthwith ≥3 workedconsecutivelyModafinil 200 mgPlaceboTaken 30-60 minutes beforethe start of the work shift for12 weeks89104• Mean sleep latency change frombaseline ± SD:– Modafinil: 1.7 ± 0.4 minutes– Placebo: 0.3 ± 0.3 minutes (P = .002)• Change from baseline in the medianfrequency of reported attention lapses:– Modafinil: Reduced by 2.6– Placebo: Increased by 3.8 (P < .001)• Reported accidents/near accidents whilecommuting home:– Modafinil: 29%– Placebo: 54% (P < .001)Erman et al 46 Adults (18-60years) withSWD working≥5 nightshifts/monthwith ≥3 workedconsecutivelyModafinil 200 mgModafinil 300 mgPlaceboTaken 30-60 minutes beforethe start of the work shift for12 weeks879086• Modafinil 300 mg significantly improvedoverall patient functioning vs placebo asmeasured using the FOSQ:– Increase from baseline in FoSQ FOSQ score:2.3 vs 1.6 points, respectively (P < .05)• Modafinil 200 mg and 300 mg bothsignificantly improved quality of life vsplacebo as measured using the SF-36mental health component score:– mean Mean change from baseline of 3.2, 3.7,and 0.7 points, respectively (P < .05 forboth doses vs placebo)ArmodafinilDrake et al, 47Roth et al 48Adultpermanent orrotating nightshiftworkerswith SWDworking ≥5night shifts/monthArmodafinil 150 mgPlaceboTaken 30-60 minutes beforethe start of the work shift for12 weeks112104• Mean sleep latency change frombaseline:– Armodafinil: 3.1 ± 4.5 minutes– placebo: Placebo: 0.4 ± 2.9 minutes (P < .0001)• Reported ES levels on the KSS weresignificantly reduced with armodafinil vsplacebo (P < .005).• Change in the maximum level ofsleepiness (electronic diary data)– During the work shift: 2.0 vs 1.1 points,respectively (P < .0001)– During the commute home: 1.2 vs 0.6points, respectively (P = .0027)ES, excessive sleepiness; FOSQ, Functional Outcomes of Sleep Questionnaire; KSS, Karolinska Sleepiness Scale; SD, standard deviation; SF-36, MedicalOutcomes Study Short-Form (36-item) Health Survey; SWD, shift-work disorder.Supplement to The Journal of Family Practice • Vol 59, No 1 / January 2010 S29
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