What Is Molindone?
Molindone is an antipsychotic medication used for the management of schizophrenia [1.2.1, 1.3.3]. First approved for medical use in the U.S. in 1974, it belongs to a class of drugs known as first-generation or "typical" antipsychotics [1.2.1, 1.5.6]. It was sold for many years under the brand name Moban [1.2.1].
Chemically, molindone is a dihydroindolone derivative, which makes it structurally different from many other antipsychotics like phenothiazines [1.2.1, 1.5.6]. Its primary mechanism of action is believed to be the blocking of dopamine D2 receptors in the brain [1.2.2]. By antagonizing dopamine, it helps to reduce psychotic symptoms such as hallucinations and disorganized thinking [1.3.3]. It is typically administered orally as a tablet, usually three or four times a day [1.2.5].
The Tumultuous History of Molindone's Availability
The path of molindone in the U.S. market has been marked by several interruptions. For decades, it was a treatment option for schizophrenia, but its availability has been inconsistent since 2010.
The Original Discontinuation of Moban
On January 13, 2010, Endo Pharmaceuticals, the manufacturer of the brand-name drug Moban, announced it was stopping production [1.2.3, 1.3.4]. The U.S. Food and Drug Administration (FDA) and the company clarified that this was a business decision, often cited as being due to poor sales, and was not related to any safety or efficacy concerns [1.4.2, 1.4.3]. In 2013, the FDA formally determined that Moban was not withdrawn from the market for reasons of safety or effectiveness, a decision that opened the door for generic manufacturers to produce the drug [1.2.4, 1.5.3].
A Cycle of Relaunch and Discontinuation
Following the FDA's determination, the medication saw a brief return. In December 2015, Core Pharma launched a generic version of molindone, bringing it back to the market [1.2.2, 1.4.1]. However, this availability was short-lived, as Core Pharma subsequently discontinued its production sometime between 2015 and 2017 [1.2.1, 1.3.9].
This led to another period where the drug was unavailable. Finally, in December 2018, Epic Pharma began marketing and selling molindone in the USA, where it remains available today [1.3.2, 1.5.1].
Clinical Profile and Unique Characteristics
Molindone is considered an intermediate-potency typical antipsychotic [1.2.2]. This places its side effect profile between high-potency agents (which have a higher risk of extrapyramidal symptoms, or EPS) and low-potency agents (which tend to cause more sedation and anticholinergic effects) [1.2.2].
A Unique Effect on Weight
One of the most notable features of molindone, which sets it apart from nearly all other antipsychotics, is its association with weight loss [1.3.5]. Most first- and second-generation antipsychotics are known to cause significant weight gain, which can lead to metabolic syndrome, diabetes, and high cholesterol [1.6.4, 1.6.6]. In contrast, molindone has been shown to reduce weight in some patients, making it a potentially valuable option for individuals concerned about this common side effect [1.2.2].
Other Side Effects and Warnings
Despite its unique weight profile, molindone carries the risks common to typical antipsychotics. These can include:
- Extrapyramidal Symptoms (EPS): Drug-induced movement disorders, such as tremors and muscle stiffness [1.2.1].
- Tardive Dyskinesia: A potentially irreversible condition involving uncontrollable muscle movements, often around the mouth [1.5.6].
- Sedation and Agitation: Drowsiness is a common, dose-related side effect [1.2.2].
- Neuroleptic Malignant Syndrome (NMS): A rare but life-threatening reaction to antipsychotic drugs [1.5.6].
- Blood Disorders: Rare reports of leukopenia (low white blood cell count) and neutropenia have been noted [1.4.9].
Like all antipsychotics, molindone carries an FDA boxed warning about the increased risk of death in elderly patients with dementia-related psychosis [1.4.7].
Comparison of Molindone to a Modern Alternative
Today, second-generation "atypical" antipsychotics are more commonly prescribed than older drugs like molindone. Here is a comparison with risperidone, a widely used atypical antipsychotic.
| Feature | Molindone (Typical) | Risperidone (Atypical) |
|---|---|---|
| Primary Use | Schizophrenia [1.2.1] | Schizophrenia, Bipolar Disorder [1.6.2] |
| Mechanism | Primarily blocks Dopamine (D2) receptors [1.2.2] | Blocks Dopamine (D2) and Serotonin (5-HT2A) receptors [1.6.2] |
| Effect on Weight | Associated with weight loss [1.2.2] | Associated with significant weight gain [1.6.2, 1.6.6] |
| Risk of EPS | Moderate [1.2.2] | Lower than typicals at low doses, but increases with dose [1.6.4] |
| Metabolic Risk | Low | Moderate to high (hyperglycemia, high cholesterol) [1.6.6] |
| Current Status | Generic available [1.5.1] | Brand (Risperdal) and generic available [1.6.2] |
Modern Alternatives for Schizophrenia
While molindone is still available, the treatment landscape for schizophrenia is now dominated by second-generation antipsychotics (SGAs), which generally have a lower risk of causing movement-related side effects [1.6.4].
Commonly prescribed SGAs include:
- Aripiprazole (Abilify) [1.6.5]
- Olanzapine (Zyprexa) [1.6.5]
- Quetiapine (Seroquel) [1.6.5]
- Risperidone (Risperdal) [1.6.5]
- Ziprasidone (Geodon) [1.6.2]
- Lurasidone (Latuda) [1.6.2]
- Paliperidone (Invega) [1.6.2]
Clozapine is a particularly effective SGA, often reserved for treatment-resistant schizophrenia due to its risk of serious side effects [1.6.5].
Conclusion
So, is molindone available in the US? The answer is yes. After a turbulent history of discontinuations and relaunches, generic molindone is back on the market [1.5.1]. However, its place in modern psychiatry has largely been supplanted by newer, atypical antipsychotics that offer a different balance of efficacy and side effects for most patients [1.6.4, 1.6.5]. Molindone's unique potential for weight loss keeps it a relevant, if less common, option for specific patients [1.2.2]. Its story serves as a clear example of how commercial factors, not just clinical merit, can dictate a medication's journey and accessibility to patients.
For more information from an authoritative source, you can review its profile on MedlinePlus: https://medlineplus.gov/druginfo/meds/a682238.html [1.2.5].
