Study suggests paliperidone has potential to treat insomnia

Paliperidone ER, a new chemical entity, is the first and only atypical antipsychotic to use OROS extended-release technology. The OROS technology was developed by subsidiaries of Johnson & Johnson. This technology is said to provide a consistent release of medication over a 24-hour period.

Trials of paliperidone ER resulted in statistically significant improvements in mean sleep measurements compared to placebo. These improvements included a reduction of over half an hour in the time required to first fall asleep, and a reduction of more than 40 minutes in the time required to remain persistently asleep. Enhanced sleep continuity and duration were demonstrated by an increase in total sleep time approaching an hour.

The most commonly reported adverse events were involuntary movements, tremors, rigidity and headache in the paliperidone ER group.

“This is the first time a placebo-controlled study of this size was designed to specifically assess multiple parameters of sleep in a group of patients with schizophrenia who have specific complaints of insomnia,” said Remy Luthringer, lead investigator of the study. “We found in this study that patients receiving paliperidone ER fell asleep faster and stayed asleep longer than those on placebo. This suggests that paliperidone ER may provide an important additional benefit for the many patients with schizophrenia in whom sleep disturbance is a problem.”

Upon approval by regulatory authorities, paliperidone ER will be marketed by Janssen-Cilag. The trade name for the product has not yet been determined.

Worldwide, it is estimated that one person in every 100 develops schizophrenia, one of the most serious types of mental illness.