Somnolence aripiprazole

The most common side effects associated with aripiprazole include headache, nausea, dyspepsia, agitation, anxiety, insomnia, somnolence, and akathisia. Dose-related adverse events include somnolence and akathisia. Early clinical experience indicates that akathisia may be avoided by starting the medication at doses lower than 10 mg and increasing the dose slowly. Aripiprazole is not associated with significant sedation, anticholinergic side effects, weight gain, or cardiovascular side effects (Petrie et al. 1997). 

Aripiprazole causes mild somnolence in about 11% of patients and severe somnolence has also been reported in a 9-year-old girl 3.5 hours after a single dose of aripiprazole 15 mg (9). 

Davenport JD, McCarthy MW, Buck ML. Excessive somnolence from aripiprazole in a child. Pharmacotherapy 2004 24(4) 522-5. 

Placebo-controlled studies In a 6-week multicenter, double-blind, randomized, placebo-controlled study, patients aged 13-17 years with schizophrenia were assigned to aripiprazole (10 mg/day, n= 100 30 n day, n = 102) or placebo (n = 100) [59 ]. At the end of the study, both doses of aripiprazole significantly reduced PANSS total scores. Adverse events that occurred in more than 5% of subjects in either aripiprazole group and with a combined incidence at least twice the rate for placebo were extrapyramidal disorders, somnolence, and tremor. Mean changes in prolactin concentrations were... 

In a 12-week, multicenter, randomized, double-blind, placebo-controlled trial of aripiprazole in the treatment of alcoholism in 295 subjects, aripiprazole produced more positive subjective effects and less overall severity of alcohol dependence than placebo, although there was no difference between aripiprazole and placebo on the primary end-point, possibly because of dose-related attrition (treatment was started at 2 mg/day and titrated to a maximum of 30 mg/day at day 28). Withdrawals (40% versus 27%) and treatment-related adverse effects (83% versus 64%) were more common with aripiprazole. The most common treatment-related adverse events that differed significantly between aripiprazole and placebo were fatigue, insomnia, restlessness, somnolence, anxiety, and altered attention serious adverse reactions attributed to aripiprazole were chest pain, cellulitis, migraine, and thrombosis extrapyramidal adverse reactions attributed... 

Four SGA long-acting injections are currently available risperidone microspheres, olanzapine pamoate, paliperidone palmitate and aripiprazole extended-release injection. The extended-release characteristics are achieved differently with each drug. A case analysis of clinical frials with olanzapine pamoate (2000-2008) reported an occurrence of postinjection delirium/sedation syndrome in approximately 0.07% of injections or 1.4% of patients [78 ]. A review of the published literature and clinical trial databases for olanzapine pamoate, risperidone microspheres and paliperidone palmitate found only one other case of postinjection delirium/sedation syndrome occurring in a patienf on placebo in a paliperidone palmitate trial. In four randomised, double-blind, placebo-controlled trials of paliperidone palmitate, the most common treatment-emergent adverse event was somnolence/sedation overall treatment discontinuation rates due to adverse events were similar to placebo. 

Observational Studies In a 12-week study of children and adolescents with autism spectrum disorders switched from risperidone to aripiprazole, mild somnolence was observed only in one subject and there were no significant changes in vital signs, weight or ECG while serum prolactin levels decreased significantly [90 ]. 

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