What Is Raldesy? Uses, Dosage, and What You Need to Know in 2026

Raldesy is a brand-name prescription medication containing trazodone hydrochloride in an oral liquid solution. FDA-approved in 2024, it holds the distinction of being the first and only FDA-approved oral liquid formulation of trazodone. Here's everything you need to know about Raldesy in 2026.

What Is Raldesy?

Raldesy (trazodone hydrochloride oral solution) is a prescription antidepressant manufactured by Validus Pharmaceuticals LLC and trademarked by Rubicon Research Ltd. It is available at a concentration of 10 mg/mL and comes in two bottle sizes: 150 mL (a 30-day supply at typical doses) and 300 mL.

Raldesy is classified as a serotonin antagonist and reuptake inhibitor (SARI) — an atypical antidepressant. Trazodone has been prescribed in the United States since 1981, when it was first approved under the brand name Desyrel. Raldesy represents the first FDA-approved liquid form of this well-established medication.

What Is Raldesy Approved to Treat?

Raldesy is FDA-approved for the treatment of major depressive disorder (MDD) in adults. It is not approved for use in pediatric patients.

Major depressive disorder is characterized by persistent sad, empty, or hopeless mood; loss of interest in activities; fatigue; sleep disturbances; changes in appetite; difficulty concentrating; and, in severe cases, thoughts of death or suicide. MDD is one of the leading causes of disability worldwide.

Off-Label Uses of Trazodone (Raldesy)

While Raldesy's only FDA-approved indication is MDD, trazodone is commonly prescribed off-label for:

Insomnia: At lower doses (25–100 mg), trazodone is one of the most commonly prescribed off-label sleep aids due to its sedating properties. Unlike controlled sleep medications, it carries no DEA scheduling or dependence risk.

Anxiety: Trazodone's serotonergic and sedating effects may help with anxiety, particularly when co-prescribed with SSRIs.

PTSD-related nightmares: The American Academy of Sleep Medicine suggests trazodone may help with nightmares associated with PTSD.

Fibromyalgia: Some clinicians use trazodone off-label for fibromyalgia, particularly when sleep disturbance is a major symptom.

What Makes Raldesy Different From Generic Trazodone Tablets?

Raldesy and generic trazodone tablets contain the same active ingredient — trazodone hydrochloride — but Raldesy's liquid format provides distinct advantages for certain patients:

Liquid form: Ideal for patients with dysphagia (difficulty swallowing), elderly patients, post-surgical patients, or those in care settings where tablet administration is difficult.

FDA-approved liquid: Unlike compounded liquid trazodone, Raldesy has passed FDA's rigorous review for safety, quality, and consistency.

Precise dosing: Comes with a measured oral dosing syringe (10 mL capacity) and bottle adapter for accurate dose measurement.

Caregiver-friendly: The liquid format makes caregiver-assisted administration simpler and more consistent.

Neutral taste: Unlike crushed tablets, Raldesy has a neutral taste, making it more palatable.

How Is Raldesy Dosed?

Raldesy is prescribed as an oral liquid at 10 mg/mL. For the treatment of major depressive disorder:

Starting dose: 150 mg per day, taken in divided doses (e.g., 75 mg twice daily or 50 mg three times daily)

Dose increases: May be increased by 50 mg per day every 3–4 days based on clinical response and tolerability

Maximum dose (outpatient): 400 mg per day in divided doses

Maximum dose (inpatient): Up to 600 mg per day for more severely depressed hospitalized patients

How to Take Raldesy Correctly

Follow these instructions for correct administration:

Always take Raldesy after a meal or light snack to reduce nausea and improve absorption

Use the included bottle adapter and oral dosing syringe to measure your prescribed dose accurately

Store at room temperature (68°F–77°F / 20°C–25°C), away from light

Discard any unused medication remaining in the bottle 20 days after first opening it

Do not stop taking Raldesy without discussing a tapering plan with your prescriber

Is Raldesy a Controlled Substance?

No. Trazodone (including Raldesy) is not classified as a controlled substance by the DEA. It has no recognized abuse potential or dependence liability. This means:

No special DEA prescription requirements (e.g., no limit on refills by federal law)

Can be prescribed via telehealth without an in-person visit requirement

Can be e-prescribed through standard electronic health record systems

How Do You Find Raldesy?

Raldesy is available by prescription from pharmacies, though not all locations stock it. Use medfinder to have pharmacies near you contacted on your behalf to find which ones can fill your Raldesy prescription. The manufacturer also offers a patient support program that can help with cost and access — visit patient.raldesy.com or call ConnectiveRx at 877-384-1417.