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RALDESY™ is a trademark of Validus Pharmaceuticals LLC. All rights reserved.
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RALDESY™ is a trademark of Validus Pharmaceuticals LLC.
All rights reserved.
Actor portrayals.
Not actual product size.
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Discover the
liquid innovation that offers treatment for adults with major
depressive disorder (MDD) in an easy-to-swallow oral solution.
Liquid formulation for established efficacy and easier dosing!
Calibrated oral dosing syringe features clear dose indicators for ease of titration
Ready-to-use solution and a calibrated oral dosing syringe for personalized care
The oral solution supports a gradual reduction in dose
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.
RALDESY™ is the “First and Only FDA-Approved Oral Liquid Trazodone” that is a safe
and effective option to treat patients with MDD.1
A convenient trazodone solution for flexibility and ease of administration
Provides an alternative for patients who find it challenging to take tablets or capsules
Liquid formulation eliminates the need to split or dissolve tablets for hassle-free dosing
Not actual product size.
Liquid dosing makes RALDESY™ an ideal choice to reduce caregiver burden
RALDESY™ is stable at controlled room temperature (20°C to 25°C/68°F to 77°F) and does not require refrigeration
Unlike tablets with strong tastes, RALDESY™ has a neutral taste, making it a palatable solution for patients
RALDESY™ Oral Solution, 10 mg/mL, comes in bottle with a child-resistant cap, a bottle adapter, and a 10 mL calibrated oral dosing syringe, allowing patients or caregivers to conveniently prepare and take the measured dose. The calibrated oral dosing syringe features clear dose indicators for ease of titration. RALDESY™ is available in two convenient pack sizes1:
White, opaque, high-density polyethylene (HDPE) bottle
White, opaque, HDPE bottle
The initial dosage of RALDESY™ for the treatment of MDD in adults is 150 mg daily, taken orally, in divided doses. The dosage should be initiated at a low-dose and increased gradually, depending on clinical response and tolerance. Occurrence of drowsiness may require the administration of a major portion of the daily dose at bedtime or a reduction of dosage.
The dose may be increased by 50 mg daily every 3-4 days. The maximum recommended dosage for outpatients should not exceed 400 mg daily in divided doses. Inpatients (ie, more severely depressed patients) may be given up to, but not in excess, of 600 mg daily in divided doses.
Gradually reduce dosage to avoid adverse reactions upon discontinuation. Adverse reactions after discontinuation of serotonergic antidepressants, particularly after abrupt discontinuation, include nausea, sweating, dysphoric mood, irritability, agitation, dizziness, sensory disturbances (eg, paresthesia, such as electric shock sensations), tremor, anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, and seizures.
Administer RALDESY™ orally after a meal or light snack. When dosing, the use of the calibrated oral dosing syringe (included in the pack) is recommended to measure and deliver the prescribed dose accurately. A household teaspoon or tablespoon is not an adequate measuring device. Check the Instructions for Use Video and the Medication Guide.
Convert RALDESY™ dose from mg to mL with precision
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.
RALDESY™ has well established safety and tolerability profile. Most common adverse reactions (incidence ≥5% and twice that of placebo) are edema, blurred vision, syncope, drowsiness, fatigue, diarrhea, nasal congestion, and weight loss.
Please click here for full Prescribing Information including Boxed WARNING and Medication Guide.
RALDESY™ Liquid Innovation With Care™ Patient Support Program
Designed to ensure convenient access to RALDESY™, regardless of insurance coverage, while prioritizing patient care.
Validus is committed to improving patient access to treatment through the RALDESY™ Liquid Innovation With Care™ Patient Support Program. Designed to help patients start and stay on treatment, the program provides comprehensive support throughout their journey.
All programs are subject to change or termination without prior notice.
Once you prescribe RALDESY™ (trazodone hydrochloride oral solution), your patients may enroll in the program to access benefits.
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 your patients.
For more information or assistance, please contact ConnectiveRx Customer Service at 877-384-1417.
Our one-stop service provides comprehensive support in navigating patient coverage:
For assistance, please contact Reimbursement Revenue Solutions (HUB) at:
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.
For uninsured patients who meet eligibility requirements, the program offers free access to medication.
For more information, contact our support team at:
References
Read
More
Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors. RALDESY™ is not approved for use in pediatric patients.
RALDESY™ is indicated for the treatment of major depressive disorder (MDD) in adults.
Administer RALDESY orally after a meal or light snack.
RALDESY is contraindicated in patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (MAOIs), including MAOIs such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome.
Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients
It is unknown whether the risk of suicidal thoughts and behaviors in pediatric and young adult patients extends to longer-term use, i.e., beyond four months.
Monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing RALDESY, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.
Selective serotonin reuptake inhibitors (SSRIs), including RALDESY, can precipitate serotonin syndrome, a potentially life-threatening condition. The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort) and with drugs that impair metabolism of serotonin, i.e., MAOIs. Serotonin syndrome can also occur when these drugs are used alone.
The concomitant use of RALDESY with MAOIs is contraindicated. In addition, do not initiate RALDESY in a patient being treated with MAOIs such as linezolid or intravenous methylene blue. If it is necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient taking RALDESY, discontinue RALDESY before initiating treatment with the MAOI.
Monitor all patients taking RALDESY for the emergence of serotonin syndrome. Discontinue treatment with RALDESY and any concomitant serotonergic agents immediately if the above symptoms occur, and initiate supportive symptomatic treatment.
RALDESY should be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and the presence of congenital prolongation of the QT interval. RALDESY is not recommended for use during the initial recovery phase of myocardial infarction. Caution should be used when administering RALDESY to patients with cardiac disease and such patients should be closely monitored, since antidepressant drugs (including RALDESY) may cause cardiac arrhythmias.
Hypotension, including orthostatic hypotension and syncope has been reported in patients receiving trazodone hydrochloride. Concomitant use with an antihypertensive may require a reduction in the dose of the antihypertensive drug.
Inform patients about the risk of bleeding associated with the concomitant use of RALDESY and antiplatelet agents or anticoagulants. For patients taking warfarin, carefully monitor coagulation indices when initiating, titrating, or discontinuing RALDESY.
RALDESY should be used with caution in males who have conditions that might predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, or leukemia), or in men with anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, or Peyronie’s disease).
In patients with bipolar disorder, treating a depressive episode with RALDESY or another antidepressant may precipitate a mixed/manic episode. Activation of mania/hypomania has been reported in a small proportion of patients with major affective disorder who were treated with antidepressants. Prior to initiating treatment with RALDESY, screen patients for any personal or family history of bipolar disorder, mania, or hypomania.
Adverse reactions after discontinuation of serotonergic antidepressants, particularly after abrupt discontinuation, include: nausea, sweating, dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesia, such as electric shock sensations), tremor, anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, and seizures. A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible.
RALDESY™ may cause somnolence or sedation and may impair the mental and/or physical ability required for the performance of potentially hazardous tasks. Patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that the drug treatment does not affect them adversely.
The pupillary dilation that occurs following use of many antidepressant drugs (including RALDESY) may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy. Avoid use of antidepressants, including RALDESY, in patients with untreated anatomically narrow angles.
Hyponatremia may occur as a result of treatment with SSRIs and serotonin and norepinephrine reuptake inhibitors (SNRIs), including RALDESY. Cases with serum sodium lower than 110 mmol/L have been reported. Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which can lead to falls. Signs and symptoms associated with more severe and/or acute cases have included hallucination, syncope, seizure, coma, respiratory arrest, and death. In many cases, this hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH).
In patients with symptomatic hyponatremia, discontinue RALDESY and institute appropriate medical intervention. Elderly patients, patients taking diuretics, and those who are volume-depleted may be at greater risk of developing hyponatremia with SSRIs and SNRIs. See Full Prescribing Information for warnings and precautions of RALDESY.
See Full Prescribing Information for additional warnings and precautions associated with RALDESY.
The following serious adverse reactions are described elsewhere in the labeling:
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.
See Full Prescribing Information for additional adverse reactions associated with RALDESY.
Monoamine Oxidase Inhibitors (MAOIs)
RALDESY is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue.
Other Serotonergic Drugs
Monitor patients for signs and symptoms of serotonin syndrome, particularly during RALDESY initiation. If serotonin syndrome occurs, consider discontinuation of RALDESY and/or concomitant serotonergic drugs.
Antiplatelet Agents and Anticoagulants
Inform patients of the increased risk of bleeding with the concomitant use of RALDESY and antiplatelet agents and anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio (INR) when initiating or discontinuing RALDESY.
Strong CYP3A4 Inhibitors
If RALDESY is used with a potent CYP3A4 inhibitor, the risk of adverse reactions, including cardiac arrhythmias, may be increased and a lower dose of RALDESY should be considered.
Strong CYP3A4 Inducers
Patients should be closely monitored to see if there is a need for an increased dose of RALDESY when taking CYP3A4 inducers.
Digoxin and Phenytoin
Patient serum digoxin or phenytoin concentrations should be measured before initiating concomitant use of RALDESY. Continue monitoring and reduce digoxin or phenytoin dose as necessary.
Central Nervous System (CNS) Depressants
Patients should be counseled that RALDESY may enhance the response to alcohol, barbiturates, and other CNS depressants.
QT Interval Prolongation
Avoid the use of RALDESY in combination with other drugs known to prolong QT.
See Full Prescribing Information for additional potential drug interactions associated with RALDESY.
Pregnancy
There are risks associated with untreated depression in pregnancy. Trazodone hydrochloride has been shown to cause increased fetal resorption and other adverse effects on the fetus in the rat when given at dose levels approximately 7.3 to 11 times the maximum recommended human dose (MRHD) of 400 mg/day in adults on a mg/m2 basis.
Pregnancy Exposure Registry
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers should encourage patients to enroll by calling the National Pregnancy Registry for Antidepressants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants/.
Lactation
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for RALDESY and any potential adverse effects on the breastfed child from RALDESY or from the underlying maternal condition.
Pediatric Use
Safety and effectiveness of RALDESY in pediatric patients have not been established. Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric patients.
Geriatric Use
Serotonergic antidepressants have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse reaction.
Renal Impairment
RALDESY should be used with caution in this population.
Hepatic Impairment
RALDESY should be used with caution in this population.
RALDESY (10 mg/mL) Oral Solution: Clear,
colorless solution.
RALDESY is available only by prescription.
Death from overdose has occurred in patients concurrently ingesting trazodone and other CNS depressant drugs (e.g., alcohol; alcohol and chloral hydrate and diazepam; amobarbital; chlordiazepoxide; or meprobamate).
The most severe reactions reported to have occurred with overdose of trazodone alone have been priapism, respiratory arrest, seizures, and ECG changes, including QT prolongation. The reactions reported most frequently have been drowsiness and vomiting.
Overdosage may cause an increase in incidence or severity of any of the reported adverse reactions.
There is no specific antidote for trazodone hydrochloride overdose. Consider contacting the Poison Help line at 1-888-222-1222 or a medical toxicologist for additional overdose management recommendations.
Please see Full Prescribing Information including Boxed WARNING at www.raldesy.com.
RAL-500-24
Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors. RALDESY is not approved for use in pediatric patients.
RALDESY™ is indicated for the treatment of major depressive disorder (MDD) in adults.
Administer RALDESY orally after a meal or light snack.
RALDESY is contraindicated in patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (MAOIs), including MAOIs such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome.
Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients
It is unknown whether the risk of suicidal thoughts and behaviors in pediatric and young adult patients extends to longer-term use, i.e., beyond four months.
Monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing RALDESY, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.
Selective serotonin reuptake inhibitors (SSRIs), including RALDESY, can precipitate serotonin syndrome, a potentially life-threatening condition. The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort) and with drugs that impair metabolism of serotonin, i.e., MAOIs. Serotonin syndrome can also occur when these drugs are used alone.
The concomitant use of RALDESY with MAOIs is contraindicated. In addition, do not initiate RALDESY in a patient being treated with MAOIs such as linezolid or intravenous methylene blue. If it is necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient taking RALDESY, discontinue RALDESY before initiating treatment with the MAOI.
Monitor all patients taking RALDESY for the emergence of serotonin syndrome. Discontinue treatment with RALDESY and any concomitant serotonergic agents immediately if the above symptoms occur, and initiate supportive symptomatic treatment.
RALDESY should be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and the presence of congenital prolongation of the QT interval. RALDESY is not recommended for use during the initial recovery phase of myocardial infarction. Caution should be used when administering RALDESY to patients with cardiac disease and such patients should be closely monitored, since antidepressant drugs (including RALDESY) may cause cardiac arrhythmias.
Hypotension, including orthostatic hypotension and syncope has been reported in patients receiving trazodone hydrochloride. Concomitant use with an antihypertensive may require a reduction in the dose of the antihypertensive drug.
Inform patients about the risk of bleeding associated with the concomitant use of RALDESY and antiplatelet agents or anticoagulants. For patients taking warfarin, carefully monitor coagulation indices when initiating, titrating, or discontinuing RALDESY.
RALDESY should be used with caution in males who have conditions that might predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, or leukemia), or in men with anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, or Peyronie’s disease).
In patients with bipolar disorder, treating a depressive episode with RALDESY or another antidepressant may precipitate a mixed/manic episode. Activation of mania/hypomania has been reported in a small proportion of patients with major affective disorder who were treated with antidepressants. Prior to initiating treatment with RALDESY, screen patients for any personal or family history of bipolar disorder, mania, or hypomania.
Adverse reactions after discontinuation of serotonergic antidepressants, particularly after abrupt discontinuation, include: nausea, sweating, dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesia, such as electric shock sensations), tremor, anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, and seizures. A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible.
RALDESY™ may cause somnolence or sedation and may impair the mental and/or physical ability required for the performance of potentially hazardous tasks. Patients should be cautioned about operating machinery, including automobiles, until they are reasonably certain that the drug treatment does not cause them drowsiness.
The pupillary dilation that occurs following use of many antidepressant drugs (including RALDESY) may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy. Avoid use of antidepressants, including RALDESY, in patients with untreated anatomically narrow angles.
Hyponatremia may occur as a result of treatment with SSRIs and serotonin and norepinephrine reuptake inhibitors (SNRIs), including RALDESY. Cases with serum sodium lower than 110 mmol/L have been reported. Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which can lead to falls. Signs and symptoms associated with more severe and/or acute cases have included hallucination, syncope, seizure, coma, respiratory arrest, and death. In many cases, this hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH).
In patients with symptomatic hyponatremia, discontinue RALDESY and institute appropriate medical intervention. Elderly patients, patients taking diuretics, and those who are volume-depleted may be at greater risk of developing hyponatremia with SSRIs and SNRIs. See Full Prescribing Information for warnings and precautions of RALDESY.
See Full Prescribing Information for additional warnings and precautions associated with RALDESY.
The following serious adverse reactions are described elsewhere in the labeling:
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.
See Full Prescribing Information for additional adverse reactions associated with RALDESY.
Monoamine Oxidase Inhibitors (MAOIs)
RALDESY is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue.
Other Serotonergic Drugs
Monitor patients for signs and symptoms of serotonin syndrome, particularly during RALDESY initiation. If serotonin syndrome occurs, consider discontinuation of RALDESY and/or concomitant serotonergic drugs.
Antiplatelet Agents and Anticoagulants
Inform patients of the increased risk of bleeding with the concomitant use of RALDESY and antiplatelet agents and anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio (INR) when initiating or discontinuing RALDESY.
Strong CYP3A4 Inhibitors
If RALDESY is used with a potent CYP3A4 inhibitor, the risk of adverse reactions, including cardiac arrhythmias, may be increased and a lower dose of RALDESY should be considered.
Strong CYP3A4 Inducers
Patients should be closely monitored to see if there is a need for an increased dose of RALDESY when taking CYP3A4 inducers.
Digoxin and Phenytoin
Patient serum digoxin or phenytoin concentrations should be measured before initiating concomitant use of RALDESY. Continue monitoring and reduce digoxin or phenytoin dose as necessary.
Central Nervous System (CNS) Depressants
Patients should be counseled that RALDESY may enhance the response to alcohol, barbiturates, and other CNS depressants.
QT Interval Prolongation
Avoid the use of RALDESY in combination with other drugs known to prolong QT.
See Full Prescribing Information for additional potential drug interactions associated with RALDESY.
Pregnancy
There are risks associated with untreated depression in pregnancy. Trazodone hydrochloride has been shown to cause increased fetal resorption and other adverse effects on the fetus in the rat when given at dose levels approximately 7.3 to 11 times the maximum recommended human dose (MRHD) of 400 mg/day in adults on a mg/m2 basis.
Pregnancy Exposure Registry
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers should encourage patients to enroll by calling the National Pregnancy Registry for Antidepressants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants/.
Lactation
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for RALDESY and any potential adverse effects on the breastfed child from RALDESY or from the underlying maternal condition.
Pediatric Use
Safety and effectiveness of RALDESY in pediatric patients have not been established. Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric patients.
Geriatric Use
Serotonergic antidepressants have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse reaction.
Renal Impairment
RALDESY should be used with caution in this population.
Hepatic Impairment
RALDESY should be used with caution in this population.
RALDESY (10 mg/mL) Oral Solution: Clear, colorless solution.
RALDESY is available only by prescription.
Death from overdose has occurred in patients concurrently ingesting trazodone and other CNS depressant drugs (e.g., alcohol; alcohol and chloral hydrate and diazepam; amobarbital; chlordiazepoxide; or meprobamate).
The most severe reactions reported to have occurred with overdose of trazodone alone have been priapism, respiratory arrest, seizures, and ECG changes, including QT prolongation. The reactions reported most frequently have been drowsiness and vomiting.
Overdosage may cause an increase in incidence or severity of any of the reported adverse reactions.
There is no specific antidote for trazodone hydrochloride overdose. Consider contacting the Poison Help line at 1-888-222-1222 or a medical toxicologist for additional overdose management recommendations.
Please see Full Prescribing Information including Boxed WARNING at www.raldesy.com.
RAL-500-24
©2025 Validus Pharmaceuticals LLC.
