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RALDESY Is a Prescription Liquid Oral
Trazodone Hydrochloride1

Discover a liquid product that offers treatment for adults with major
depressive disorder (MDD) in an easy-to-swallow oral solution.

INDICATIONS AND USAGE

RALDESY is indicated for the treatment of major depressive disorder (MDD) in adults.

Please click here for full Prescribing Information including Boxed WARNING and Medication Guide.

Why RALDESY

RALDESY is the “First and Only FDA-Approved Oral Liquid Trazodone” that is a safe
and effective option to treat you with MDD.

Convenient

Liquid Innovation With Care

A convenient trazodone hydrochloride liquid for flexibility and ease of administration

Easy to swallow

Tailored for Enhanced Compliance

Provides an alternative for you if you find it challenging to take tablets or capsules

No Cutting or Crushing Pills

No Cutting or Crushing

A hassle-free solution and ready-to-use liquid form

Bottle

Not actual product size.

Caregiver-Friendly

Caregiver-Friendly

The liquid form makes RALDESY caregiver friendly

RALDESY Does Not Need to be Refrigerated

Stable at Room Temperature

Can be left at room temperature

Taste

Palatability

RALDESY does not have a strong taste, making it easier to take

Dosage and Administration

RALDESY Oral Solution, 10 mg/mL, comes in bottle with a child-resistant cap, a bottle adapter, and a 10 mL measured oral dosing syringe, allowing patients or caregivers to conveniently prepare and take the measured dose. The measured oral dosing syringe features clear dose marks for easy measuring your dose. RALDESY is available in two convenient pack sizes of 150 mL and 300 mL.1

Instructions for Use Video

Your healthcare professional should explain to you how to take RALDESY Oral Solution before you use it for the first time. Read the Instructions for Use in the Medication Guide before you start taking RALDESY. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

Please click here for full Prescribing Information including Boxed WARNING and Medication Guide.

Safety1

Most common side effects are fluid retention,blurred vision,fainting, drowsiness, tiredness diarrhea, nasal congestion, and weight loss.

Please click here for full Prescribing Information including Boxed WARNING and Medication Guide.

Savings Card & Support

RALDESY Liquid Innovation With Care
Patient Support Program


Designed to ensure convenient access to RALDESY, regardless of insurance coverage, while prioritizing your care.

Validus is committed to improving your access to treatment through the RALDESY Liquid Innovation With Care Patient Support Program. Designed to help you start and stay on therapy, the program offers comprehensive support throughout your treatment journey.

Copay

Copay Support

The Copay Card can help eligible, commercially insured patients access their medication for as little as $10 for a 30-day supply.* Click here to download a copay card.

For more information or assistance, please contact ConnectiveRx Customer Service at 877-384-1417.

  • *Eligibility: Available to patients with commercial insurance coverage for RALDESY (traZODone hydrochloride) who meet eligibility criteria. This copay assistance program is not available to patients receiving prescription reimbursement under any federal, state, or government-funded insurance programs (for example, Medicare [including Part D], Medicare Advantage, Medigap, Medicaid, TRICARE, Department of Defense, or Veterans Affairs programs) or where prohibited by law. The offer is subject to change or termination without prior notice. Restrictions, including monthly maximums, may apply.
  • This is not health insurance. For full Terms and Conditions, visit ConnectiveRx Customer Service at 877-384-1417 for additional information.

For Cash-Paying Patients With Insurance but No RALDESY Coverage

For patients whose insurers are not covering RALDESY, the Program offers a straightforward, affordable option to access medication. Eligible patients can purchase RALDESY at a reduced cost through this program, ensuring uninterrupted access to their treatment.

Cash Program
Patient Assistance Program (PAP)

Patient Assistance Program (PAP)

For uninsured patients who meet eligibility requirements, the program offers free access to medication. Click Here to download Patient Support Program Form

References

  • RALDESY. Prescribing information. Validus Pharmaceuticals; 2024.

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IMPORTANT SAFETY INFORMATION

What is the most important information I should know about RALDESY?

RALDESY can cause serious side effects, including:

  • Increased risk of suicidal thoughts or actions. RALDESY and other antidepressant medicines increase the risk of suicidal thoughts and actions in people 24 years of age and younger, especially during the first few months of treatment or when the dose is changed. RALDESY is not for use in children.
  • Depression and other mental illnesses are the most important causes of suicidal thoughts and actions.
How can I watch for and try to prevent suicidal thoughts and actions?
  • Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings if you develop suicidal thoughts or actions. This is very important when an antidepressant medicine is started or when the dose is changed.
  • Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts or feelings, or if you develop suicidal thoughts or actions.
  • Keep all follow-up visits with your healthcare provider. Call your provider between visits if needed, especially if you are worried about symptoms.

Call a healthcare provider right away if you have symptoms such as attempts to commit suicide, thoughts about suicide or dying, agitation, restlessness, anger, irritability, acting on dangerous impulses, new or worsening depression, trouble sleeping, aggression, violence, new or worse anxiety or panic attacks, or increased activity or talking more than normal.

What is RALDESY?

RALDESY is a prescription medicine used in adults to treat major depressive disorder (MDD).

CONTRAINDICATIONS

Do not take RALDESY if you are taking or have stopped taking within the last 14 days a Monoamine Oxidase Inhibitor (MAOI), including the antibiotic linezolid and intravenous methylene blue. Do not start taking an MAOI for at least 14 days after stopping RALDESY.

Before taking RALDESY, tell your healthcare provider if you:
  • have or have a family history of heart problems, including fast or slow heartbeat, or changes in heart electrical activity (QT prolongation)
  • have ever had a heart attack
  • have or have had bleeding problems
  • are male and have conditions that may cause prolonged or painful erections (priapism), such as sickle cell anemia, multiple myeloma, leukemia, or a deformed penis
  • have or have a family history of bipolar disorder, mania, or hypomania
  • have high pressure in the eye (glaucoma)
  • have low sodium levels in your blood
  • are pregnant or plan to become pregnant
  • are breastfeeding or plan to breastfeed

Tell your healthcare provider about all medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Serious Side Effects

RALDESY can cause serious side effects, including:

Serotonin Syndrome

A potentially life-threatening problem that can happen when you take RALDESY with certain other medicines. Symptoms include agitation, hallucinations, confusion, coma, fast heartbeat, changes in blood pressure, sweating, flushing, high body temperature, tremors, stiff muscles, muscle twitching, loss of coordination, seizures, nausea, vomiting, diarrhea, dizziness.

Changes in the electrical activity of your heart (QT prolongation)

Call your healthcare provider right away if you have abnormal heartbeats, dizziness, feeling lightheaded, or fainting.

Low blood pressure and fainting

Low blood pressure can happen when standing up from sitting or lying down, causing dizziness or fainting.

Increased risk of bleeding

Taking RALDESY with aspirin, NSAIDs, warfarin, or blood thinners may increase bleeding risk. Report unusual bleeding or bruising.

Painful erection lasting more than 6 hours (priapism)

If you have an erection lasting more than 4 hours, get medical help right away.

Manic episodes

Symptoms include greatly increased energy, racing thoughts, unusually grand ideas, talking more or faster, severe sleep problems, reckless behavior, extreme happiness or irritability.

Discontinuation Syndrome

Do not suddenly stop RALDESY. Symptoms include nausea, electric shock sensations, sweating, tremor, sleep problems, mood changes, anxiety, hypomania, irritability, agitation, confusion, tinnitus, dizziness, headache, seizures.

Eye problems (angle-closure glaucoma)

RALDESY may trigger angle-closure glaucoma in people with certain eye conditions. Seek help for vision changes, eye pain, redness, or swelling.

Low sodium in your blood (hyponatremia)

Symptoms include headache, confusion, difficulty concentrating, weakness, unsteadiness, memory problems. Severe symptoms include hallucinations, coma, fainting, respiratory arrest, seizures.

ADVERSE REACTIONS

The most common side effects of RALDESY include: swelling, blurred vision, fainting, sleepiness, tiredness, diarrhea, stuffy nose, weight loss.

To report SUSPECTED ADVERSE REACTIONS, contact Validus Pharmaceuticals LLC at 1-866-982-5438 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Full Prescribing Information including Boxed WARNING and Medication Guide and discuss questions with your healthcare provider.

RAL-602-25

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about RALDESY?

RALDESY can cause serious side effects, including:

  • Increased risk of suicidal thoughts or actions. RALDESY and other antidepressant medicines increase the risk of suicidal thoughts and actions in people 24 years of age and younger, especially during the first few months of treatment or when the dose is changed. RALDESY is not for use in children.
  • Depression and other mental illnesses are the most important causes of suicidal thoughts and actions.
How can I watch for and try to prevent suicidal thoughts and actions?
  • Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings if you develop suicidal thoughts or actions. This is very important when an antidepressant medicine is started or when the dose is changed.
  • Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts or feelings, or if you develop suicidal thoughts or actions.
  • Keep all follow-up visits with your healthcare provider. Call your provider between visits if needed, especially if you are worried about symptoms.

Call a healthcare provider right away if you have symptoms such as attempts to commit suicide, thoughts about suicide or dying, agitation, restlessness, anger, irritability, acting on dangerous impulses, new or worsening depression, trouble sleeping, aggression, violence, new or worse anxiety or panic attacks, or increased activity or talking more than normal.

What is RALDESY?

RALDESY is a prescription medicine used in adults to treat major depressive disorder (MDD).

CONTRAINDICATIONS

Do not take RALDESY if you are taking or have stopped taking within the last 14 days a Monoamine Oxidase Inhibitor (MAOI), including the antibiotic linezolid and intravenous methylene blue. Do not start taking an MAOI for at least 14 days after stopping RALDESY.

Before taking RALDESY, tell your healthcare provider if you:
  • have or have a family history of heart problems, including fast or slow heartbeat, or changes in heart electrical activity (QT prolongation)
  • have ever had a heart attack
  • have or have had bleeding problems
  • are male and have conditions that may cause prolonged or painful erections (priapism), such as sickle cell anemia, multiple myeloma, leukemia, or a deformed penis
  • have or have a family history of bipolar disorder, mania, or hypomania
  • have high pressure in the eye (glaucoma)
  • have low sodium levels in your blood
  • are pregnant or plan to become pregnant
  • are breastfeeding or plan to breastfeed

Tell your healthcare provider about all medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Serious Side Effects

RALDESY can cause serious side effects, including:

Serotonin Syndrome

A potentially life-threatening problem that can happen when you take RALDESY with certain other medicines. Symptoms include agitation, hallucinations, confusion, coma, fast heartbeat, changes in blood pressure, sweating, flushing, high body temperature, tremors, stiff muscles, muscle twitching, loss of coordination, seizures, nausea, vomiting, diarrhea, dizziness.

Changes in the electrical activity of your heart (QT prolongation)

Call your healthcare provider right away if you have abnormal heartbeats, dizziness, feeling lightheaded, or fainting.

Low blood pressure and fainting

Low blood pressure can happen when standing up from sitting or lying down, causing dizziness or fainting.

Increased risk of bleeding

Taking RALDESY with aspirin, NSAIDs, warfarin, or blood thinners may increase bleeding risk. Report unusual bleeding or bruising.

Painful erection lasting more than 6 hours (priapism)

If you have an erection lasting more than 4 hours, get medical help right away.

Manic episodes

Symptoms include greatly increased energy, racing thoughts, unusually grand ideas, talking more or faster, severe sleep problems, reckless behavior, extreme happiness or irritability.

Discontinuation Syndrome

Do not suddenly stop RALDESY. Symptoms include nausea, electric shock sensations, sweating, tremor, sleep problems, mood changes, anxiety, hypomania, irritability, agitation, confusion, tinnitus, dizziness, headache, seizures.

Eye problems (angle-closure glaucoma)

RALDESY may trigger angle-closure glaucoma in people with certain eye conditions. Seek help for vision changes, eye pain, redness, or swelling.

Low sodium in your blood (hyponatremia)

Symptoms include headache, confusion, difficulty concentrating, weakness, unsteadiness, memory problems. Severe symptoms include hallucinations, coma, fainting, respiratory arrest, seizures.

ADVERSE REACTIONS

The most common side effects of RALDESY include: swelling, blurred vision, fainting, sleepiness, tiredness, diarrhea, stuffy nose, weight loss.

To report SUSPECTED ADVERSE REACTIONS, contact Validus Pharmaceuticals LLC at 1-866-982-5438 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Full Prescribing Information including Boxed WARNING and Medication Guide and discuss questions with your healthcare provider.

RAL-602-25