This randomized, double-blind study examined the effects of modafinil in adults with shift work sleep disorder. Subjects were randomly assigned to receive either 200 mg of modafinil or a placebo before their scheduled night shifts for 12 weeks.

Efficacy

In this randomized, double-blind, within-participant study, participants were randomly assigned to receive either 200 mg modafinil online australia (Provigil, Cephalon) or a placebo taken 30 to 60 minutes before the start of their night shift.

Subjects were tested for cognitive performance, mood, and measures of sleep, on the first day of the night shift, then on their next 'off' day while performing simulated work under two different shift conditions (day and night).

Results showed that when subjects were treated with modafinil versus placebo, they were more alert throughout the night shift and on their morning commute home, and had less fatigue than patients who took placebo.

They also had fewer lapses of attention, which can lead to accidents and poor job performance. Furthermore, diary data indicated that modafinil decreased the maximum level of excessive sleepiness during the night shift and the drive home.

These findings were maintained when subjects were given modafinil for 12 weeks in a follow-up trial. It is important to note, however, that the study population was limited to those who met the criteria for SWSD; this may not be representative of the broader shift-worker population, and longer-term studies will be necessary to determine whether these improvements in functioning and quality of life are sustained over time. The results of this study demonstrate that modafinil reduces the extreme sleepiness that is associated with SWSD, and improves patient functioning, mood, and quality of life.

Safety

Shift workers are prone to sleep disturbances, especially during night shifts, and have reported a variety of health, social, and economic problems associated with this condition (US Congress Office of Technology Assessment, 1991). For example, they are more likely than daytime schedule workers to decline family activities or to have work-related accidents due to impaired performance.

Those in the study who were randomly assigned to receive modafinil did not experience significant adverse effects during the trial period. Similarly, both the 200-mg and 400-mg doses of modafinil significantly increased ratings of 'Alert' during the nighttime testing with the Psychomotor Vigilance Test compared to placebo (Table 1).

These effects on subjective ratings of alertness were consistent with objective measures of wakefulness during the night shift, as shown in Table 1.

Additionally, patients treated with the 200-mg dose had a reduction in the frequency and duration of lapses of attention in the nighttime tests with the Psychomotor Vigilance Test, while those receiving the 400 mg dose showed a greater improvement in these measures (Table 2).

During the study period, no serious or unexpected side effects were observed. All patients were monitored for serious adverse events on the SF-36 and FOSQ, as well as for any drug-related adverse event. In addition, a comprehensive clinical assessment was performed to ensure that the eligibility criteria were met.

Side Effects

Diary data showed that 200 mg of modafinil significantly reduced the maximum level of sleepiness experienced during night shifts and decreased levels of sleepiness on the commute home in comparison with the placebo treatment (Table 2).

Additionally, fewer patients receiving Modalert Tablet had accidents or near-accidents on the commute home. These benefits were maintained in extension studies of the original study.

During the daytime, modafinil produced a modest improvement in performance and mood when compared with placebo. The drug also improved cognitive/psychomotor performance on various tests, such as the digit span and verbal fluency tests.

However, the improvements in these tests were not sufficient to improve patient-estimated sleepiness and performance in a broader population of shift workers.

Modafinil may reduce your reaction time, so you should not drive or operate machinery until you know how this medication affects you. Also, avoid alcoholic beverages and marijuana (cannabis) while taking this medication. Follow your doctor’s instructions on how to take this medicine.

Do not increase or decrease the dose without your doctor’s approval. If you miss a dose, take it as soon as possible. Do not double the dose to make up for a missed one. Store this medication at room temperature, away from light and moisture.

Keep all medications out of the reach of children. Talk to your doctor if you have questions about how to properly store this medicine.

Interactions

The pharmacokinetic properties of Modafinil have been determined, and it does not significantly affect the activity of cytochrome P450 enzymes. It does not interact with a large number of other medications, but it should be avoided in patients taking diuretics (medicines that help to reduce fluid retention), antidepressants, sedatives, and some antipsychotics.

It should be used with caution in patients who take monoamine oxidase inhibitors (medicines that inhibit the breakdown of certain neurotransmitters) or cyclosporine, as this may cause an increase in blood levels of both the drug and its metabolites.

In the present study, both 200-mg and 400-mg doses of modafinil attenuated night shift-related cognitive/psychomotor impairments in a dose-dependent manner.

This result is consistent with the finding of Walsh et al (2004) that a single dose of modafinil can improve performance on immediate recall and psychomotor vigilance tests, although the results of the two studies are somewhat different.

Subjective ratings of alertness showed a similar pattern, with both active doses of modafinil improving the rating of 'Alert' on nights one and three. However, measures of daytime functioning (ie, clinical global impression of severity and polysomnography) did not change as a function of the treatment group.

Thus, the observed improvements in performance and mood that occurred during the night shift on both active doses of modafinil were likely a result of the medication's stimulant effects rather than an improvement in circadian adaptation to the night shift.