Azilect as Add-on to Requip May Improve Sleep Quality

Steve Bryson, PhD avatar

by Steve Bryson, PhD |

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Parkinson's disease early detection | Parkinson's News Today | Diagnosis | illustration of sleepless man and bed

Azilect (rasagiline) as an add-on therapy to Requip (ropinrole) improved sleep, reduced the need for sleep medications, and enhanced quality of life in a small group of people with Parkinson’s disease, a study suggested.

These findings support more extensive studies to confirm the sleep-related benefits of Azilect, the researchers concluded.

The study, “Rasagiline, sleep quality and well-being in Parkinson’s disease: a pilot study,” was published in the journal Neurological Sciences.

Up to 70% of people with Parkinson’s experience sleep disturbances, which are difficult to manage, according to the study authors. In addition, anti-Parkinson’s medications may worsen sleep problems, such as those that increase the level of dopamine, which is abnormally low in Parkinson’s patients.

Monoamine oxidase-B (MAO-B) inhibitors are a class of Parkinson’s medications that block the breakdown of dopamine to maintain levels in the brain. They often are prescribed alongside levodopa, a chemical converted into dopamine.

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Eldepryl is an MAO-B inhibitor that is degraded to L-amphetamine, a stimulant known to increase wakefulness. Conversely, Azilect is another MAO-B inhibitor that has no amphetamine-like properties. Accordingly, recent studies suggest Azilect may help alleviate Parkinson’s-associated sleep disturbances.

To further investigate the impact of Azilect as an add-on therapy to improve sleep, researchers at the University Hospital of Parma in Italy conducted a single-center pilot study in a small group of Parkinson’s patients being treated with Requip, a dopamine agonist that mimics dopamine in the brain.

The team compared eight people with Parkinson’s who received both Azilect and Requip with nine patients treated with Requip alone. The mean age of all participants was 66 years, with a mean disease duration of 3.7 years. The mean Azilect duration of a 1 mg dose was about one year.

Sleep quality was assessed with the Pittsburgh Sleep Quality Index (PSQI), which measured subjective sleep quality, time to fall asleep, sleep duration, habitual sleep patterns, sleep disturbances, the use of sleep medication, and daytime impairment. A score above five indicates poor sleep quality.

The analysis revealed that patients taking Azilect had significantly better sleep (lower PSQI scores) compared to those who did not (overall 4.8 vs. 7.6). Examining the subcategories of PSQI showed the difference was mainly driven by the occasional use of hypnotic sleep medications in those not treated with Azilect.

Daytime sleepiness also was significantly lessened with add-on Azilect therapy than without (7.4 vs. 9.7), as measured by the Epworth Sleepiness Scale, a tool to assess the propensity for sleep in common situations. Values greater than 10 indicated excessive daytime sleepiness.

Overall, quality of life, using the 36-Item Short Form Healthy Survey (SF-36), was similar between the two groups. However, an examination of subcategories showed Azilect significantly improved social functioning, energy and fatigue, perceived emotional well-being, and general health perception.

In the Azilect and Requip group, statistical analysis found a negative correlation between higher PSQI scores (worse sleep) and lower scores (worsened quality of life) in four subitems of the SF-36. Those subitems included exploring the role of limitation due to emotional problems, emotional well-being, pain, and general health.

In the Requip-only group, there was a negative correlation between higher PSQI scores and all the subitems of the SF36 questionnaire except for general health. After adjusting for multiple comparisons, however, the correlations in both groups were no longer statistically significant.

“[Azilect] significantly improved sleep quality, reduced the need for hypnotic medications, ameliorated social functioning, increased the level of subjective daily energy and augmented the perceived emotional well-being,” the authors concluded. “Considering the relevance of sleep disturbances in [Parkinson’s disease] management, wider studies are needed to consolidate these promising results.”