Evaluating the effectiveness and safety of continuous subcutaneous night-time only apomorphine for the treatment of insomnia in patients with Parkinson’s disease.

This study evaluated the effectiveness and safety of continuous subcutaneous night-time only apomorphine (Apokyn) infusion for the treatment of insomnia in patients with Parkinson’s disease (PD). The data showed that continuous subcutaneous night-time only apomorphine was effective in improving sleep disturbances in patients with advanced PD and moderate to severe insomnia with manageable side effects.

Parkinson’s disease (PD) is a chronic disorder that affects certain brain cells. This disease can cause movement symptoms such as tremors, muscle rigidity, and decreased balance. The standard treatment for this disorder is levodopa. However, this therapy is associated with high levels of side effects. Therefore, new treatment regimens are necessary.

Apomorphine is another drug used for the treatment of PD. It is usually administered by subcutaneous (under the skin) injections. It has been shown to reduce the periods of decreased effectiveness associated with levodopa treatment. However, it has a short effect. Continuous subcutaneous apomorphine infusion (CSAI) uses an electronic delivery device (pump), in order to maintain constant blood levels of apomorphine. Prior studies showed that CSAI improves movement symptoms of patients with no signs of cognitive problems (difficulty in remembering, learning, and concentrating).

Patients with PD can often suffer from insomnia, and it negatively affects their quality of life. Insomnia can be defined as the inability to fall or stay asleep. Drugs that improve both sleep and PD would be of major benefit to patients with PD-related insomnia. Whether administering apomorphine during the night only as a continuous subcutaneous infusion would improve insomnia in patients with PD is still unknown.

This study involved 46 patients with advanced PD and moderate to severe insomnia. Patients were randomly assigned to two treatment periods. For the first treatment period, 25 patients received apomorphine during the night as a continuous subcutaneous infusion and 21 patients received a placebo. For the second treatment period, 25 patients received a placebo and 21 patients received an apomorphine infusion. The 2 treatment periods were separated by a 14-day washout period. Patients’ sleep disturbances were measured according to the Parkinson’s disease sleep scale (PDSS) scores from the beginning to the end of each treatment period. A lower score means more severe sleep disturbances.

The average change in PDSS score was significantly greater with night-time apomorphine infusion compared with placebo. Apomorphine significantly improved sleep disturbance (insomnia) compared to placebo in the patients.

Side effects were reported in 54% of the patients during the apomorphine period and in 37% of the patients during the placebo period. Apomorphine was associated with more frequent dizziness compared to placebo.

This study concluded that continuous subcutaneous night-time only apomorphine was effective in improving sleep disturbances in patients with advanced PD and moderate to severe insomnia with manageable side effects.

This study was funded by Orkyn and Aguettant Pharma, the manufacturers of apomorphine. The sample size was very small. This study only included patients treated at institutions in France.