Somnolence ziprasidone

The most common side effects are headache, dyspepsia, nausea, constipation, abdominal pain, somnolence, and EPS. Ratings of parkinsonism and akathisia with ziprasidone, 120 mg/day, did not differ from those with placebo. Although dizziness has been reported, rates of orthostatic hypotension have not differed from rates associated with placebo in controlled clinical trials. 

Published and unpublished studies from 1995 to 2004, in which intramuscular ziprasidone was assessed, have been reviewed (9). The most common adverse events in the 921 patients were nausea, headache, dizziness, anxiety, somnolence, insomnia, and injection-site pain 1.1 to 6.1% withdrew because of treatment-related adverse events. 

Ziprasidone has been used in 28 children and adolescents (aged 7-17 years) with Tourette s syndrome in an 8-week pilot study (11). They were randomly assigned to ziprasidone (5-40 mg/day n = 16) or placebo (n = 12). Ziprasidone significantly reduced tic frequency. There was one case each of somnolence and akathisia, both with the highest dose of ziprasidone these were considered to be severe but did not necessitate withdrawal. 

In a randomized, Phase III, double-blind study, ziprasidone 80 mg/day and 160 mg was more effective than placebo in patients with acute exacerbations of schizophrenia or schizoaffective disorders (n = 302) (20). After 6 weeks, somnolence (19%) and akathisia (13%) were more frequent with ziprasidone 160 mg than with placebo (5 and 7% each). Benzatropine was required at some time during the study by 20% of the patients taking ziprasidone 80 mg/day, 25% of those taking ziprasidone 160 mg/day, and 13% of those taking placebo. The long-term safety of ziprasidone is unknown. 

A 17-year-old man with a 5-year history of severe depression took 120 tablets of ziprasidone 20 mg (2400 mg), 15-20 tablets of bupropion SR 150 mg (2250-3000 mg), 15 tablets of clonazepam 0.5 mg, and 4 tablets of lorazepam 0.5 mg (32). He was somnolent but responded to vocal commands. Over the next 45... 

Ketoconazole caused a modest increase in the mean AUC (33%) and the mean Cmax (34%) of ziprasidone. This effect was not considered clinically relevant and suggests that other inhibitors of CYP3A4 are unlikely to affect the pharmacokinetics of ziprasidone significantly. Most of the reported adverse events were mild. The adverse events that were most commonly reported in subjects who took the drugs concomitantly were dizziness, weakness, and somnolence. There were no treatment-related laboratory abnormalities or abnormal vital signs during the study and at the 6-day follow-up evaluation. 

Observational studies Numerous open studies of ziprasidone promoted by Pfeer, the marketing authorization holder, have previously been published [SEDA-32, 111] and further studies, similarly promoted, have emerged. Of 185 subjects who were switched from olanzapine or risperidone to ziprasidone, 72 completed a 1-year extension study [136 ]. The most common adverse effects were insomnia (23%) and somnolence (11%) no patient had a corrected QT interval over 500 ms at any time during the study. 

A study of intramuscular ziprasidone versus intramuscular haloperidol for managing agitation in a Chinese population was conducted [14 ]. There were fewer adverse events with ziprasidone particularly extrapyramidal symptoms and the most common adverse events with ziprasidone were dizziness and somnolence. Most subjects had no clinically significant changes in ECG five ziprasidone and three haloperidol patients had a QTcF>450ms. 

In a 4-week, randomised, open-label comparison of ziprasidone and clozapine in the treatment of psychotic symptoms in Parkinson s disease, the most common initial adverse effect was somnolence [47 ]. There was no difference in movement disorder scales between the two antipsychotics. 

Controlled Studies A study of pooled data from nine randomised, double-blind, placebo-controlled, acute studies of ziprasidone in bipolar mood disorder and schizophrenia was conducted [279 -]. The risk of discontinuation due to adverse events or >7% weight gain was not different to placebo. The risk for akathisia was significantly higher for mood disorders and the risk of extrapyramidal symptoms and somnolence (dose dependent) was significantly higher for both mood disorders and schizophrenia compared to placebo. 

---