Table 2. Approval status and relevant “Red-Hand Letters*¹” for parenterally administered drugs for the treatment of psychomotor agitation.

Preparation	Approval status	Administration	Red-Hand Letter
Aripiprazole 7.5 mg/mL solution for injection	Approved only to control agitation and behavioral disturbance in patients with schizophrenia or mania as a component of bipolar I disorder Not approved to treat psychosis or agitation/behavioral disturbance in patients with dementia or other diseases	i. m.	Red-Hand Letter, 2005 Dose-dependent elevation of the frequency of cerebrovascular events in patients with Alzheimer’s dementia
Haloperidol solution for injection	Approved to treat psychomotor agitation of psychotic origin	i. m.	–
Lorazepam solution for injection	Baseline sedation before and during operations and diagnostic procedures; for severe manifestations of neurotic anxiety and phobia; for severe anxiety and agitation in patients with psychosis or depression, if treatment with antipsychotic or antidepressant drugs is ineffective; for status epilepticus	i. v. or i. m.	–
Loxapine powder in individual doses for inhalation *2	For mild to moderate agitation in adult patients with schizophrenia or bipolar I disorder	by inhalation	–
Midazolam solution for injection*3	For analgosedation, general anesthesia, and sedation in the intensive-care unit	i. v. (for children also i. m., rectal)	–
Olanzapine powder for production of a solution for injection	For the rapid treatment of agitation and behavioral disturbance in schizophrenia or manic episodes Not approved to treat psychosis or agitation/behavioral disturbance in patients with dementia or other diseases	i. m.	Red-Hand Letter, 2004 Doubled mortality and trebled incidence of cerebrovascular events in elderly patients treated for dementia-associated psychosis and agitation/behavioral disturbance
Promethazine solution for injection	For acute allergic reactions of the immediate type, if sedation is required at the same time; for acute states of unrest and agitation in the context of an underlying mental illness Not approved for the treatment of behavioral disturbances in the the context of dementia	i. v. or i. m.	–

*¹ In Germany, these letters are used by pharmaceutical companies to communicate important information to medical professionals, e.g., newly discovered adverse effects of drugs or batch recalls.

*² May only be given in a hospital under the supervision of medical staff; bronchodilating therapy with a ß2-mimetic drug must be available in case it is needed.

*³ No psychiatric indication stated.

i.m., intramuscular; i. v., intravenous