The prespecified primary efficacy variable was the rating of improvement in sleepiness on the ESS questionnaire at the final visit. Secondary outcomes included the simulated driving ability and simple reaction times.

Modalert and armodafinil both stimulate wakefulness by increasing levels of dopamine in parts of the brain that control sleep-wake cycles. They are favored over other medications for excessive daytime sleepiness because they do not have sympathomimetic effects or cause sleep rebound.

Efficacy

The article states that Modalert Tablet and its R-enantiomer armodafinil are effective in treating shift work sleep disorder (SWSD). This is based on a 12-week, randomized, double-blind, comparative trial of 211 patients with SWSD who were randomized to receive either modafinil or placebo one hour before their night shift.

Efficacy was measured by mean improvement in the Stanford Sleepiness Scale (ESS) grade, compliance with treatment, and patients’ and physicians’ global assessment of efficacy.

All patients underwent a full medical screening and medical history review by a qualified sleep medicine physician. Those who clinically presented with driving-related sleepiness that could endanger public safety were excluded from the study.

Patients were screened for hepatic and renal impairment, psychological disorders, use of drugs metabolized by the cytochrome P450 enzyme CYP3A4, and sleep apnoea severity.

In the article, Dr. Pagel promotes the concept of excessive daytime sleepiness as a legitimate condition that requires treatment with Provigil, his sponsor’s blockbuster drug. I am dismayed that he did not disclose this conflict of interest. In addition, he is on a speaker panel for Sepracor, Inc., the maker of another blockbuster sleep drug.

These conflicts of interest are inappropriate for an AFP article. AFP has a policy on conflict of interest that should have been adhered to in this case.

Side Effects

It is also often used off-label as a cognitive enhancer, although research on this use has been mixed.

It is a wakefulness-inducing drug that increases dopamine levels in the brain, improving sleep and awakening. It also improves memory. It has been shown to reduce depression and fatigue in some patients. It has been reported that some patients develop a tolerance to the drug and some experience negative side effects.

They are generally well tolerated by most patients, and both have similar efficacy and safety profiles.

Studies comparing armodafinil and modafinil have found that a single dose of 150 mg of armodafinil produces results comparable to 200 mg of modafinil in shift work sleep disorder patients.

This suggests that armodafinil may be slightly stronger than modafinil on a milligram-to-milligram basis. Both medications significantly improve sleepiness and increase wakefulness in patients with narcolepsy and shiftwork sleep disorders, and both have good tolerability.

Availability

The AFP article describes a clinical trial of buy modafinil australia (Provigil) as the first to show the drug's effectiveness in treating excessive daytime sleepiness, which has become a well-known diagnosis promoted by Cephalon, the maker of Provigil. I was dismayed that the AFP article so closely linked this "concept of illness" to the blockbuster drug.

The study was a randomized, double-blind, placebo-controlled clinical trial of 211 patients with shift work sleep disorder (SWSD) who received either 150 mg/day of armodafinil or 200 mg/day of modafinil.

A pretreatment visit established baseline levels of alertness and performance, the severity of sleepiness, and results from overnight polysomnography; a randomization visit assigned the patients to treatment groups; and the final-visit efficacy analyses compared ratings on the Clinical Global Impression of Change test for improvement in sleepiness with a change in mean score on the Multiple Sleep Latency Test at that time.

The trial enrolled men aged 18 to 70 years who had SWSD diagnosed by overnight in-laboratory polysomnography, an AHI of 5-30 per hour, and an ESS score of 10 or more; no history of other sleep disorders; no comorbid psychiatric disorder; no current use of CPAP or mandibular advancement splint; no significant hepatic or renal impairment; no alcohol or drug abuse; and no prior treatment with modafinil or armodafinil. Baseline assessment included a medical screening questionnaire and blood tests to screen for hepatic and renal function, sitting blood pressure, and height and weight.

Cost

Modalert is available only with a prescription and requires an initial office visit to confirm eligibility and subsequent visits for refills. Its cost is comparable to other agents, and it is not covered by insurance. It is not known whether the drug is safe for long-term use.

The study was a three-month, randomized, double-blind, placebo-controlled trial of modafinil in shift work sleep disorder. It was conducted at 28 centers in the United States and included a screening visit, a baseline visit performed on the night after working a shift, and monthly assessments during an overnight laboratory shift at each site.

The primary efficacy variable was changed from baseline to the final visit in the Clinical Global Impression of Change scale, and the second variable was the mean change from baseline to the final visit in the sleep latency score on the Multiple Sleep Latency Test.

Six academic investigators and four representatives from the sponsor designed the study. Patients were recruited from an external referral pathway and underwent a complete medical screen, including overnight in-laboratory polysomnography, to establish eligibility for the study.