Methylphenidate, a psycho-stimulant drug, also known by its 1948 trademarked name of Ritalin, could be useful in the treatment of excessive daytime sleepiness (EDS) for DM1 patients, according to a recent study conducted by The Department of Human Genetics at the Centre Hospitalier Universitaire de Quebec in Quebec City, Canada.
A total of 24 French-Canadian patients who had DM1 and an Epworth Sleepiness Scale score of more than 10 (0-9: normal, 10-24: sleepy and medical advice should be sought) were invited to participate in the 3-week crossover trial of 20-mg/d of methylphenidate versus a placebo. There were two groups in the study; one group took the drug for 3 weeks, followed by a 2-week washout period, followed by 3 weeks of placebo, and the other group took placebo for 3 weeks, followed by a 2-week washout period, followed by 3 weeks of drug. Of the 24 patients (12 men; 12 women; median age 46 years), 17 completed the study.
Patients’ Daytime Sleepiness Scale and the Epworth Sleepiness Scale, measured at the end of each 3-week period, were used to measure the effectiveness of methylphenidate as a treatment for EDS. The drug’s effectiveness was also determined by a mean sleep latency test, patients’ energy and vitality after the study, and patients’ moods. Tolerability to treatment was monitored by blood pressure, the results of an echocardiogram, and other lab tests. Adverse reactions to the treatment were based on patients’ reporting and were recorded at each visit to the clinic.
The study concluded that a single 20-mg/d dose of methylphenidate significantly reduced daytime sleepiness in this small group of patients with DM1. The median scores on the Epworth Sleepiness Scale and the Daytime Sleepiness Scale showed a significant change. However, measurements of patients’ moods, energy, and vitality showed no changes, and the mean sleep latency test showed no significant changes. The most common adverse effects included nausea, loss of appetite, and palpitations, as reported by more patients who were treated with methylphenidate than by those receiving the placebo. Three patients stopped taking methylphenidate due to adverse effects that arose during treatment, which included diarrhea, nervousness and irritability. One patient died during the trial, but the autopsy results eliminated methylphenidate as the cause of death.