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Olanzapine is authorised in the world under the following brand names: Olansek, Symbyax, Zydis, Zyprexa, Zyprexa Intramuscular, Zyprexa Zydis.

Atypical Antipsychotics: Atypical antipsychotics have become a standard of care in schizophrenia and they are increasingly being used as mood stabilizers. Additionally, new dosage forms are making them more useful in acute agitation. The IM formulation of olanzapine is pending approval by the FDA and offers a rapid onset of action within 15 to 30 minutes; meanwhile the IM formulation of ziprasidone continues to be evaluated and may be marketed in the near future. Zyprexa Zydis (olanzapine) is an effervescent tablet that dissolves in seconds once coming into contact with saliva. While this route does not speed the onset of effect as the drug is not absorbed through the oral mucosa and requires swallowing of the tablet, it does provide a barrier to patients who may wish to “cheek” their medication. Risperidone is available as an oral solution and also provides a benefit in those patients where “cheeking” is of concern but it does not act significantly faster than the oral tablets.

Currier compared oral risperidone (2 mg) concentrate and oral lorazepam (2 mg) to IM haloperidol (5 mg) and IM lorazepam (2 mg) in the acute management of psychotic patients admitted to emergency services for medication to control their agitation. Five items from the Positive and Negative Syndrome Scale (PANSS) and the Clinical Global Impressions Scale (CGI) were administered at 15, 30, and 60 minute intervals after the medications were given. At 30 and 60 minutes, PANSS scores decreased equally and significantly in both groups. CGI scores improved from baseline to endpoint and there were no differences between groups. These findings suggest that the oral administration of risperidone with lorazepam is as effective as the IM combination of haloperidol and lorazepam.

In order for olanzapine IM to be considered for an indication for the treatment of agitation in schizophrenia, bipolar mania, and dementia, four double-blind, randomized, comparator clinical trials with olanzapine IM were conducted. The clinical trial data show a favorable response in patients with agitation secondary to schizophrenia, bipolar mania, and dementia (including patients with Alzheimer’s type dementia, vascular and mixed).All four studies were conducted over a 24-hour period, with the primary efficacy measure being at 2 hours, the timeframe for onset pivotal for managing acute agitation and aggression.

In a recent trial of 311 hospitalized schizophrenia patients with acute agitation, IM dosing of olanzapine versus IM haloperidol was evaluated in a placebo-controlled trial. Doses utilized were olanzapine 10 mg and haloperidol 7.5 mg, with patients receiving from one to three doses over a 24-hour period. The excited component of the PANSS was utilized as the primary efficacy measure. Both IM olanzapine and haloperidol were found to be efficacious, however olanzapine appeared to have a more rapid onset of effect at reducing agitation within the first hour following the initial injection, beginning at 15 minutes, compared to haloperidol. The rate of acute dystonia was 7% in the haloperidol group, while no subjects in the olanzapine group experienced a dystonic reaction. Additionally, no significant changes were noted in the QTc interval following the IM administration of either olanzapine or haloperidol.

The study in 201 bipolar mania patients compared IM olanzapine (10 mg for two doses and 5 mg for one dose), IM lorazepam (2 mg for two doses and 1 mg for one dose) and placebo (two doses and olanzapine 10 mg IM for the final dose). The investigators found that the olanzapine group had a better response at 2 and 24 hours over both placebo and lorazepam. Again, no cases of acute dystonia occurred in patients receiving olanzapine.

Another study of agitation in 270 schizophrenia patients compared four doses of IM olanzapine to 7.5 mg of IM haloperidol and placebo. The investigators found a dose-response relationship for olanzapine in reducing agitation, a superiority of haloperidol and olanzapine over placebo, and no significant differences in the safety profile between haloperidol and olanzapine except for drug-induced parkinsonism.

A study of acute agitation in 272 clinically agitated inpatients, hospitalized or nursing home residents, aged 55 or older with dementia compared IM doses of olanzapine 5.0 mg, olanzapine 2.5 mg, lorazepam 1 mg and placebo. At two hours both olanzapine doses and lorazepam had significant improvement over placebo on the PANSS-EC and Agitation-Calmness Evaluation Scale (ACES), and both 5.0 mg olanzapine and lorazepam showed superiority to placebo on the Cohen-Mansfield Agitation Inventory. At 24 hours, both olanzapine groups were superior to placebo on the PANSS-EC while lorazepam was not. There were no differences in adverse effects between the groups, including in vital signs, QTc interval, mental status or EPS. The recommended starting dose of IM olanzapine in the elderly is 2.5 mg.

Ziprasidone IM was compared to haloperidol IM in a 7-day, randomized, open-label, multicenter study in patients with acute psychotic agitation secondary to schizophrenia or schizoaffective disorder. The Brief Psychiatric Rating Scale (BPRS) and CGI were primary efficacy measures. Ziprasidone patients were given 10 mg IM with an additional 5 to 20 mg IM dose given on an as needed basis every 4 to 6 hours for three days followed by conversion to oral ziprasidone. Haloperidol patients received 2.5 to 10 mg IM every 4 to 6 hours as needed and were converted to oral haloperidol. “As needed” anxiolytic use was nearly the same between both treatment groups. At Day 3, the mean IM haloperidol dose was 11 mg and the mean IM ziprasidone dose was 27.6 mg. After seven days, the mean ziprasidone oral daily dose was 90.5 mg/day and the mean oral haloperidol dose was 14 mg/day. According to the BPRS and CGI assessment scales, ziprasidone IM was found to be more effective than haloperidol at reducing acute symptoms of psychosis, including agitation. Ziprasidone was better tolerated than haloperidol, as fewer patients experienced EPS. No QTc prolongation of greater than 20% was noted in either group and no patient had QTC greater than 500 msec.