The first under-the-skin, long-acting risperidone injection offers a new maintenance option for adults with bipolar 1 disorder.
For anyone managing bipolar 1 disorder, staying consistent with daily medication can be a challenge. Busy schedules, shifting moods, and side effects can make it easy to miss doses — and even brief gaps may disrupt mood stability.
The U.S. Food and Drug Administration (FDA) has now approved an expanded indication for risperidone (Uzedy), a long-acting injectable that offers a new maintenance treatment option for adults with bipolar 1 disorder.
It’s the first version of risperidone given as a subcutaneous injection — under the skin — that releases the medicine slowly and steadily over time. The medication is available in both one- and two-month dosing intervals, according to a press release from Teva Pharmaceuticals.
It can be used either on its own or in combination with other mood stabilizers, such as lithium or valproate products, including valproic acid (Depakene) and divalproex sodium (Depakote).
What This Means for People With Bipolar 1 Disorder
This approval doesn’t mean a new drug has entered the market, but rather a new way to receive a familiar medication. Risperidone has been used for years to help prevent manic and depressive episodes in bipolar disorder.
Instead of taking pills daily, Uzedy delivers a steady dose of medication through a quick under-the-skin injection — typically in the abdomen or upper arm — given by a healthcare provider.
For some, it eases the pressure of daily medication — no more refills or missed doses. For others, it reduces the emotional stress of taking medicine every day.
Craig Chepke, MD, a board-certified psychiatrist and medical director at Excel Psychiatric Associates in Huntersville, North Carolina, said in a statement that treatment adherence often poses one of the biggest challenges in long-term care: “Bipolar 1 disorder has profound effects on a person’s life, and staying consistent with daily oral medication can be a major hurdle. The FDA’s decision to expand Uzedy’s use offers another option that could help bridge that gap.”
Still, long-acting injectables aren’t for everyone. Some people prefer the flexibility of daily medication, while others may simply not feel comfortable with injections.
How Uzedy Compares With Other Long-Acting Options
Uzedy isn’t the first long-acting injectable form of risperidone approved for bipolar 1 disorder, but it offers some meaningful differences. Another medication, risperidone (Rykindo), was approved in 2023 for both schizophrenia and bipolar 1 disorder.
Both contain risperidone, but they differ in how and how often they’re given:
- How It’s Given Uzedy is injected under the skin (subcutaneous), while Rykindo is injected into the muscle (intramuscular). Subcutaneous injections use a smaller needle, are typically less painful, and release medication slowly and steadily. Intramuscular injections reach the bloodstream faster but can be more uncomfortable due to the deeper tissue penetration and use of a larger needle.
- How Often It’s Given Uzedy is administered once a month — or every two months — compared with Rykindo, which is injected every two weeks.
Why the FDA Approved It
The FDA based its decision to approve Uzedy for the maintenance treatment of bipolar 1 disorder on existing research showing that other risperidone formulations — both oral and injectable — are safe and effective for this condition.
The agency also drew on clinical data from Uzedy’s phase 3 schizophrenia research, including the RISE trial and SHINE study, which demonstrated its long-term safety, tolerability, and ability to reduce relapse risk. Using these results, the FDA determined that Uzedy’s extended-release formulation would likely provide similar maintenance benefits for people with bipolar 1 disorder.
Possible Side Effects and Safety Considerations
Like all antipsychotic medications, Uzedy can cause side effects ranging from mild to serious. It’s important to talk with your healthcare provider about these risks and how they’ll be monitored. Uzedy is not approved for dementia-related psychosis because of an increased risk of stroke and death.
Serious side effects may include:
- Increased stroke risk in older adults
- Neuroleptic malignant syndrome (high fever, muscle stiffness, confusion)
- Tardive dyskinesia (uncontrolled movements)
- Metabolic effects such as high blood sugar, type 2 diabetes, or weight gain
- Hormonal effects, including increased prolactin levels that may affect menstruation or sexual function.
More common side effects include drowsiness, dizziness, muscle stiffness or shaking, restlessness, increased appetite or weight gain, and mild injection site reactions ( like redness or itching).
Because Uzedy stays in the body for weeks, side effects may take longer to fade than with daily oral medications. Regular follow-up visits help ensure safety and early detection of any issues.
For full prescribing information and safety details, visit Uzedy.com.
Editorial Sources and Fact-Checking
- Kane JM et al. A Long-Term Safety and Tolerability Study of TV-46000 for Subcutaneous Use in Patients with Schizophrenia: A Phase 3, Randomized, Double-Blinded Clinical Trial. CNS Drugs. August 2024.
- FDA Approves Expanded Indication for UZEDY® (risperidone) Extended-Release Injectable Suspension as a Treatment for Adults Living with Bipolar 1 Disorder. Teva Pharmaceuticals. October 10, 2025.
- Kane JM et al. Efficacy and Safety of TV-46000, a Long-Acting, Subcutaneous, Injectable Formulation of Risperidone, for Schizophrenia: A Randomized Clinical Trial in the USA and Bulgaria. Lancet Psychiatry. December 10, 2023.
