Vyalev helped man sleep better at night, move during day: Report
50-year-old in Japan had fragmented sleep, 15 hours of off time daily
Treatment with Vyalev (foscarbidopa and foslevodopa) eased motor symptoms and sleep disturbances in a 50-year-old man with Parkinson’s disease and a history of dream enactment behavior, according to a case report from Japan.
Dream enactment behavior is a sign of rapid eye movement (REM) sleep disorder, in which patients physically act out dreams while asleep. Marked by vocal sounds and sudden arm and leg movements, it is a common nonmotor Parkinson’s symptom.
“[Vyalev] may be an effective treatment for improving nocturnal and early morning off time related symptoms as well as sleep disturbances,” researchers wrote. Off time refers to periods when medication wears off, leading to the re-emergence of Parkinson’s symptoms.
The case, “A patient with Parkinson’s disease whose sleep status improved after the introduction of continuous subcutaneous foslevodopa/ foscarbidopa infusion,” was described in Clinical Parkinsonism & Related Disorders.
Vyalev is approved to treat the motor fluctuations of advanced Parkinson’s
Parkinson’s is caused by the progressive dysfunction and death of dopaminergic neurons, the nerve cells responsible for producing dopamine, a brain chemical messenger involved in motor control. The loss of these cells results in dopamine depletion, and the start of disease symptoms.
The mainstay Parkinson’s treatment is oral levodopa, a precursor of dopamine, that works to increase the levels of dopamine. It is commonly used in combination with carbidopa, which prevents cells outside the brain from using levodopa to make dopamine, allowing more of it to reach the brain.
Vyalev is a formulation of foscarbidopa and foslevodopa, and designed to reduce motor fluctuations in people with advanced Parkinson’s. It is given by an infusion pump that continuously administers the medications into the abdomen, allowing for a more consistent dose of levodopa.
Scientists described the case of a man living with Parkinson’s for nine years, whose motor symptoms and sleep disturbances eased after initiating treatment with Vyalev. Episodes of dream enactment behavior had begun before the onset of Parkinson’s motor symptoms.
Prior to hospital admission, the man was being treated with 100 mg levodopa/carbidopa six times a day. He was able to walk during medication on times, periods of symptom control, but off times, which accounted for 15 hours daily, brought freezing of gait that prevented walking and he had difficulty standing. He was not able to work.
He also had severe hallucinations — seeing, hearing, or experiencing things that are not real — and delusions (irrational beliefs), but these eased at age 49 when he stopped taking dopamine agonists and other dopaminergic medications. Doses of dopaminergic drugs like levodopa could not be increased due to his worsening psychiatric symptoms, and non-dopaminergic drugs were ineffective.
The scientists also noted that their patient had significant “sleep fragmentation, possibly due to nocturnal off time-related symptoms.”
Shorter daily off periods, better sleep time and quality with treatment
Upon admission, the man began treatment with Vyalev, at an infusion rate of 0.17 mL/h during the day and 0.15 mL/h at night. After nine days, his motor symptoms eased, as assessed by a decrease in the MDS-Unified Parkinson’s Disease Rating Scale part 3 score (63 points before treatment and 48 points at day nine), while off time shortened to six hours a day.
His daytime sleepiness and depressive symptoms also ease, as did his motor and nonmotor Parkinson’s symptoms at night.
The man’s sleep status was assessed using a portable recording system to measure the brain’s electrical activity and REM sleep, the stage of sleep where most dreams happen. Tests, comparing measures taken at admission with those after nine days of Vyalev treatment, showed an increase in the man’s total sleep time and a decrease in the time he awakened after sleep onset. The patient’s sleep architecture, or the pattern of alternating non-REM and REM sleep periods, also improved.
“Notably, improvements in sleep architecture and sleep quality … may have had favorable effects on daytime motor function and sleepiness,” the scientists wrote, concluding that Vyalev “may be an effective treatment for improving nocturnal and early morning off time-related symptoms as well as sleep disturbances.”
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