Using Modalert to Reduce Chronic Daytime Sleepiness can reduce the effects of chronic daytime sleepiness conditions. Participants in the study had to have chronic excessive sleepiness on work nights or during commutes home, as well as a sleep efficiency of 87.5 percent or less on daytime polysomnography.The study was performed after written informed consent was obtained.
Efficacy
An indirect treatment comparison meta-analysis compared two different sleep-reduction medications for the treatment of chronic daytime sleepiness in patients with obstructive sleep apnea. The primary outcomes were improvement in the patients’ self-reported fatigue (single item scale or questionnaire instruments), mean improvement in the patients’ SSS, and compliance with the therapy. Secondary outcomes included depression and adverse effects.
Side effects
Patients with chronic daytime sleepiness were included in this study if they were able to receive a complete evaluation of their symptoms, including the presence of OSA, SWD, or narcolepsy. This evaluation included a detailed history, physical exam, and possibly laboratory tests. Patients with more than one sleep disorder may be excluded from the trial because of the potential side effects of the drug.
Modafinil is a wake-promoting drug used to treat chronic daytime sleepiness in people with narcolepsy, shift work disorder, and obstructive sleep apnea. Its mechanism of action is similar to that of classical psychostimulants and involves the histaminergic system. It activates both direct and indirect histaminergic neurons by attenuating inhibitory GABAergic input.
Primary efficacy variables are predefined.
Prespecified primary efficacy variables for the Modalert study were ESS (Epworth Sleepiness Scale), LS (least squares), MWT (Maintenance of Wakefulness Test), and PGI-C (Patient Global Impression of Change). The study was designed to measure the effects of Modalert or Modalert 200 on sleepiness and wakefulness.
Eligible patients had to be literate in English and provide informed consent. In addition, their insomnia diagnosis had to be based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. They also had to have an ISI (Sleepiness Index) of 15 or greater. Moreover, patients were excluded if they had any history of CBT, had been hypnotic-free for four weeks, or were pregnant.
The study also includes trials with a placebo. The first trial with a significant difference compared with placebo is then followed by trials with a non-significant difference. The last trial with significant results is the fifth and final trial, which also includes co-primary efficacy endpoints, the Maintenance of Wakefulness Test sleep latency, and Epworth Sleepiness Scale scores.
