Discontinue use if NMS is suspected. Not approved for treatment of patients w/ dementia-related psychosis. Monitor patients for the emergence for mania or hypomania. Increased risk of orthostatic hypotension & syncope in patients w/ dehydration, hypovolemia, history of CV disease (eg, heart failure, MI, ischemia or conduction abnormalities), history of cerebrovascular disease, antipsychotic-naive patients, treatment w/ antihypertensives. History of seizures or conditions lowering seizure threshold eg, Alzheimer's dementia; history of or at risk for sleep apnoea. Patients at risk for aspiration pneumonia. Increased sensitivity in patients w/ Parkinson's disease or dementia w/ Lewy bodies. Elevation in core body temp eg, exercising strenuously, exposure to extreme heat, concomitant medication w/ anticholinergic activity. Tardive dyskinesia; hyperglycemia, DM, dyslipidemia, wt gain; hyperprolactinemia; somnolence, postural hypotension, motor & sensory instability leading to falls; potential for cognitive & motor impairment. Monitor for clinical worsening & emergence of suicidal thoughts or behaviors. Regularly monitor patients w/ DM for worsening of glucose control; patients w/ risk factors for DM should undergo fasting blood glucose testing at the beginning & periodically during treatment. Frequently monitor CBC in patients w/ preexisting low WBC or history of drug-induced leukopenia/neutropenia. Monitor patients w/ neutropenia for fever or other symptoms of infection. Carefully evaluate for history of drug abuse & observe for signs of misuse or abuse eg, development of tolerance, drug-seeking behavior, dose increases. Long-term use (>6 wk). Avoid use w/ grapefruit & grapefruit juice. Concomitant use w/ moderate CYP3A4 inhibitors & inducers. May affect ability to drive & use machines. Moderate to severe renal & hepatic impairment. Pregnancy & lactation. Ped <13 yr. Not for irritability associated w/ autistic disorder in ped patients. Monitor neonates for extrapyramidal or w/drawal symptoms if exposed during 3rd trimester of pregnancy. Elderly ≥65 yr.