Somnolence
Patients should be informed that they may experience somnolence with
SEROQUEL* and SEROQUEL XR.†1,2
a Data combined from two 8-week, multicenter, randomized,
double-blind, placebo-controlled, monotherapy bipolar depression trials.
b Data combined from two 12-week, multicenter, randomized,
double-blind, placebo-controlled, monotherapy mania trials.
c In pivotal mania trials, the average dose in responders (patients
with
≥50% improvement in Young Mania Rating Scale total score) was 600 mg/day.
*Somnolence with SEROQUEL in bipolar depression trials was the
cumulative incidence of somnolence, sedation, lethargy, and sluggishness, and
was coded based on the Medical Dictionary for Regulatory Activities (MedDRA).
Somnolence with SEROQUEL in bipolar mania trials was coded based on Coding
Symbols for a Thesaurus of Adverse Reaction Terms (COSTART).
-
Of patients who experienced somnolence in bipolar depression trials, 87%
reported it as mild to moderate with SEROQUEL vs 97% with placebo1;
in bipolar mania trials, 97% reported somnolence as mild to moderate with
SEROQUEL vs 100% with placebo1
-
Since SEROQUEL has the potential to impair judgment, thinking, or motor skills,
patients should be cautioned about performing activities requiring mental
alertness such as operating a motor vehicle (including automobiles) or
operating hazardous machinery, until they are reasonably certain that SEROQUEL
therapy does not affect them adversely
a Data combined from three 6-week, multicenter, randomized,
double-blind, placebo-controlled schizophrenia trials.
†Somnolence with SEROQUEL XR in schizophrenia trials was the
cumulative incidence of somnolence, sedation, lethargy, and sluggishness, and
was coded based on MedDRA.
-
Of patients who experienced somnolence in schizophrenia trials, 100% reported
it as mild to moderate with SEROQUEL XR 400 mg, 95% with SEROQUEL XR 600 mg,
and 98% with SEROQUEL 800 mg vs 100% with placebo2
-
Since SEROQUEL XR has the potential to impair judgment, thinking, or motor
skills, patients should be cautioned about performing activities requiring
mental alertness such as operating a motor vehicle (including automobiles) or
operating hazardous machinery, until they are reasonably certain that SEROQUEL
XR therapy does not affect them adversely
Extrapyramidal
Symptoms
SEROQUEL XR is indicated for the acute and maintenance treatment of schizophrenia. SEROQUEL is indicated for the treatment of depressive episodes in bipolar disorder; acute manic episodes in bipolar I disorder, as either monotherapy or adjunct therapy to lithium or divalproex; for the maintenance treatment of bipolar I disorder as adjunct therapy to lithium or divalproex; and schizophrenia. Patients should be periodically reassessed to determine the need for continued treatment and the appropriate dose.
Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk (1.6 to 1.7 times) of death, compared to placebo (4.5% vs 2.6%, respectively). SEROQUEL and SEROQUEL XR are not approved for the treatment of patients with dementia-related psychosis. (See Boxed Warning.)
Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies of major depressive disorder and other psychiatric disorders. Patients of all ages started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. SEROQUEL and SEROQUEL XR are not approved for use in patients under the age of 18 years. SEROQUEL XR is not approved for the treatment of depression; however, SEROQUEL is approved for the treatment of bipolar depression. (See Boxed Warning.)
- Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma, or death, has been reported in patients treated with atypical antipsychotics, including quetiapine. The relationship of atypical use and glucose abnormalities is complicated by the possibility of increased risk of diabetes in the schizophrenic population and the increasing incidence of diabetes in the general population. However, epidemiological studies suggest an increased risk of treatment-emergent, hyperglycemia-related adverse reactions in patients treated with atypical antipsychotics. Patients starting treatment with atypical antipsychotics who have or are at risk for diabetes should undergo fasting blood glucose testing at the beginning of and periodically during treatment. Patients who develop symptoms of hyperglycemia should also undergo fasting blood glucose testing
- A potentially fatal symptom complex, sometimes referred to as Neuroleptic Malignant Syndrome (NMS), has been reported in association with administration of antipsychotic drugs, including quetiapine. Rare cases of NMS have been reported with quetiapine. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia). Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. The management of NMS should include immediate discontinuation of antipsychotic drugs
- Leukopenia, neutropenia, and agranulocytosis (including fatal cases), have been reported temporally related to atypical antipsychotics, including quetiapine. Patients with a pre-existing low white blood cell (WBC) count or a history of drug induced leukopenia/neutropenia should have their complete blood count monitored frequently during the first few months of therapy. In these patients, SEROQUEL and SEROQUEL XR should be discontinued at the first sign of a decline in WBC absent other causative factors. Patients with neutropenia should be carefully monitored, and SEROQUEL and SEROQUEL XR should be discontinued in any patient if the absolute neutrophil count is <1000/mm3
- Tardive dyskinesia (TD), a potentially irreversible syndrome of involuntary dyskinetic movements, may develop in patients treated with antipsychotic drugs. The risk of developing TD and the likelihood that it will become irreversible are believed to increase as the duration of treatment and total cumulative dose of antipsychotic drugs administered to the patient increase. TD may remit, partially or completely, if antipsychotic treatment is withdrawn. Quetiapine should be prescribed in a manner that is most likely to minimize the occurrence of TD
- Warnings and Precautions also include the risk of orthostatic hypotension, cataracts, seizures, hyperlipidemia, and possibility of suicide attempts. Examination of the lens by methods adequate to detect cataract formation, such as slit lamp exam or other appropriately sensitive methods, is recommended at initiation of treatment or shortly thereafter, and at 6-month intervals during chronic treatment. The possibility of a suicide attempt is inherent in schizophrenia, and close supervision of high risk patients should accompany drug therapy
- The most commonly observed adverse reactions associated with the use of SEROQUEL versus placebo in clinical trials for schizophrenia and bipolar disorder were dry mouth (9%-44% vs 3%-13%), sedation (30% vs 8%), somnolence (18%-34% vs 7%-9%), dizziness (9%-18% vs 5%-7%), constipation (8%-10% vs 3%-5%), asthenia (5%-10% vs 3%-4%), abdominal pain (4%-7% vs 1%-3%), postural hypotension (4%-7% vs 1%-2%), pharyngitis (4%-6% vs 3%), weight gain (5%-6% vs 1%-3%), lethargy (5% vs 2%), nasal congestion (5% vs 3%), SGPT increased (5% vs 1%), and dyspepsia (5%-7% vs 1%-4%). The most commonly observed adverse reactions associated with the use of SEROQUEL XR versus placebo in clinical trials for schizophrenia were dry mouth (12% vs 1%), constipation (6% vs 5%), dyspepsia (5% vs 2%), sedation (13% vs 7%), somnolence (12% vs 4%), dizziness (10% vs 4%), and orthostatic hypotension (7% vs 5%)
- In long-term clinical trials of quetiapine, hyperglycemia (fasting glucose ≥126 mg/dL) was observed in 10.7% of patients receiving quetiapine (mean exposure 213 days) vs 4.6% in patients receiving placebo (mean exposure 152 days)
Please see Prescribing Information for SEROQUEL and SEROQUEL XR, including Boxed Warnings.