From the Guidelines
Lithium is FDA-approved for the treatment of bipolar disorder in patients 12 years and older, specifically for acute manic episodes and maintenance therapy. The FDA approval for lithium in bipolar disorder is based on its efficacy in adults, with limited studies in children and adolescents 1. According to the practice parameter for the assessment and treatment of children and adolescents with bipolar disorder, lithium is approved down to age 12 years for acute mania and maintenance therapy 1. Key points to consider when using lithium include:
- Therapeutic serum concentration ranges from 0.6 to 1.2 mEq/L 1
- Regular monitoring of lithium levels, renal function, thyroid function, and electrolytes is essential 1
- Lithium can be effective for acute mania and maintenance therapy, but its efficacy in children and adolescents is not as well established as in adults 1
- Other agents, such as aripiprazole, valproate, olanzapine, risperidone, quetiapine, and ziprasidone, are approved for acute mania in adults, but their use in children and adolescents is not FDA-approved 1. It is crucial to weigh the potential benefits and risks of lithium treatment in individual patients, particularly in children and adolescents, and to carefully monitor their response to therapy 1.
From the FDA Drug Label
Lithium is indicated in the treatment of manic episodes of Bipolar Disorder. Lithium is also indicated as a maintenance treatment for individuals with a diagnosis of Bipolar Disorder. The FDA approval indications for lithium are:
- Treatment of manic episodes of Bipolar Disorder
- Maintenance treatment for individuals with a diagnosis of Bipolar Disorder 2
From the Research
FDA Approval Indications for Lithium
The FDA approval indications for lithium are primarily focused on its use in the treatment of bipolar disorder. The following points summarize the key indications:
- Lithium is effective in the treatment of moderate to severe manic episodes 3
- It is also used as a therapeutic option for acute bipolar depression, although its efficacy as monotherapy is still controversial 3
- Lithium is superior to placebo for the prevention of relapse or recurrence of mood episodes in bipolar I disorder patients with recent manic or hypomanic episodes 3
- It is more effective in preventing episodes of the manic/hypomanic type, including mixed episodes, than preventing depressive episodes 3
- Lithium reduces the high suicide rates associated with mood disorders 3
Specific Indications
The following specific indications are supported by the evidence:
- Acute mania: lithium is efficacious for the treatment of acute mania, including concomitant psychotic symptoms 4
- Acute bipolar depression: lithium is efficacious only in combination with specific agents 4
- Maintenance treatment: lithium is efficacious as monotherapy mainly in the prevention of manic episodes, while its efficacy for the prevention of depressive episodes is unclear 4
- Prevention of recurrences: lithium remains the gold standard for the prevention of recurrences in bipolar mood disorder 5
Clinical Predictors
The following clinical predictors may guide the use of lithium:
- Positive family history for bipolar disorder
- Mania-depression-interval pattern
- Few previous affective episodes/hospitalizations
- High risk for suicide
- No comorbidities 6