Johnson & Johnson: Paliperidone aids sleep onset, duration in schizophrenia

By Lisa Kerner

Charlotte, N.C., Sept. 19 - Johnson & Johnson Pharmaceutical Research and Development, LLC. said a multi-center study of the investigational, once-daily oral medication paliperidone extended-release (ER) tablets significantly improved sleep onset, sleep continuity and sleep duration patients diagnosed with schizophrenia- related insomnia when compared with placebo.

Paliperidone ER uses OROS extended-release technology to provide a consistent release of medication over a 24-hour period.

Adverse effects noted in the double-blind, randomized, 14-day study included involuntary movements, tremors, rigidity and headache in the paliperidone ER group and hyperkinesias, psychosis, somnolence and nausea in the placebo group.

Johnson & Johnson Pharmaceutical, located in Raritan, N.J., submitted a New Drug Application to the Food and Drug Administration in November 2005. The company's U.S. marketer and subsidiary Janssen-Cilag, NV of Titusville, N.J., submitted a Marketing Authorization Application to European health authorities in May 2006.

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