From the Guidelines
I strongly advise against using lithium orotate for treating any mental health condition due to its lack of FDA approval and insufficient clinical research supporting its safety and efficacy. Lithium orotate is a dietary supplement form of lithium that is available without a prescription, unlike prescription lithium carbonate or lithium citrate used to treat bipolar disorder. Typical commercial preparations contain much lower doses of elemental lithium (5-20 mg) compared to prescription lithium (300-900 mg) 1. People sometimes use lithium orotate for mood stabilization, depression, or anxiety, but these uses are not backed by robust clinical evidence. The supplement may cause side effects similar to prescription lithium including nausea, tremor, and kidney problems, though possibly at lower rates due to the reduced dosage.
Some key points to consider when evaluating the use of lithium orotate include:
- The lack of standardized manufacturing, quality control, and monitoring protocols of prescription lithium, creating potential risks 1
- The limited studies on the efficacy of lithium orotate in treating mental health conditions, with most studies focusing on prescription lithium carbonate or lithium citrate 1
- The importance of consulting with a healthcare provider to recommend evidence-based treatments rather than self-medicating with supplements 1
- The need for ongoing medication therapy to prevent relapse in individuals with bipolar disorder, with some requiring lifelong treatment 1
In terms of treatment options for bipolar disorder, the American Academy of Child and Adolescent Psychiatry recommends the use of traditional mood stabilizers (e.g., lithium, valproate) and/or atypical antipsychotic medications as the primary treatment, with other psychotropic agents and psychotherapies used as adjunctive therapy or to address comorbid conditions and problems 1. Lithium is approved down to age 12 years for acute mania and maintenance therapy, and is often used in combination with other medications to achieve optimal results 1.
Overall, while lithium orotate may be available without a prescription, its lack of FDA approval and insufficient clinical research supporting its safety and efficacy make it a less desirable treatment option for mental health conditions. Instead, individuals should consult with a healthcare provider to recommend evidence-based treatments and develop a personalized treatment plan.
From the FDA Drug Label
The FDA drug label does not answer the question.
From the Research
Lithium Orotate Overview
- Lithium orotate is a compound that has been proposed as an alternative to lithium carbonate for the treatment of bipolar disorder 2.
- It is suggested to have a lesser toxicity profile and may allow for reduced dosage requirements due to its ability to cross the blood-brain barrier and enter cells more readily than lithium carbonate 2, 3.
Efficacy and Potency
- Studies have shown that lithium orotate is more potent and effective than lithium carbonate in a mouse model of mania, with a near complete blockade of amphetamine-induced hyperlocomotion at concentrations of just 1.5 mg/kg 3.
- Lithium orotate has been found to have improved efficacy and potency compared to lithium carbonate, with a superior therapeutic index 3.
Toxicity and Safety
- Lithium carbonate has been associated with adverse health outcomes, including polydipsia, polyuria, hypothyroidism, and renal impairment 2, 4, 5.
- Lithium orotate has been found to have a lower toxicity profile compared to lithium carbonate, with no observed adverse effects in a 28-day repeated-dose oral toxicity study in rats 6.
- A toxicological evaluation of lithium orotate found no evidence of mutagenicity, clastogenicity, or in vivo genotoxicity, and a no observed adverse effect level was determined as 400 mg/kg body weight/day 6.
Renal Function
- Long-term lithium treatment has been associated with impaired renal function, including decreased concentrating ability and increased risk of nephrogenous diabetes insipidus 4, 5.
- Lithium orotate may have a lower risk of renal toxicity compared to lithium carbonate, although further studies are needed to confirm this 3, 6.