Are the Long-Acting Intramuscular Formulations of Risperidone or Paliperidone Palmitate Associated with Post-Injection Delirium/Sedation Syndrome? An Assessment of Safety Databases

Larry      Alphs; Srihari      Gopal; Keith      Karcher; Justine      Kent; Jennifer      Kern Sliwa; Stuart      Kushner; Isaac      Nuamah; Jaskaran      Singh

Abstract

Long-acting injectable (LAI) formulations of antipsychotics are valuable treatment alternatives for patients with psychotic disorders, and understanding their safe use is critical. Post-injection delirium/sedation syndrome (PDSS) has been reported following treatment with one atypical antipsychotic LAI. Clinical databases of risperidone LAI and paliperidone palmitate were explored to identify if cases of PDSS had been observed. No cases of PDSS were identified in 15 completed trials of 3,164 subjects (approximately 115,000 injections) or the postmarketing safety database of risperidone LAI. Only one case of PDSS was identified among 10 completed trials (3,817 subjects, 33,906 injections) of paliperidone palmitate — that case having been reported in a patient randomized to treatment with placebo. Examination of these prospective databases finds no evidence that risperidone LAI and paliperidone palmitate are associated with PDSS and suggest that findings seen with another antipsychotic LAI are not generalizable.

Keywords: Risperidone, Paliperidone Palmitate, Post-Injection Delirium/Sedation Syndrome, LAI, SSEs, MedDRA, HLGT, SMQ, hyperlipidemia, schizophrenia, parkinsonism, Placebo, microsphere, drug