RALDESY TM TRAZODONE HYDROCHLORIDE ORAL 10 mg/mL Solution, 300 mL
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Serotonin Reuptake Inhibitor class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Trazodone is used to treat depression. Trazodone is in a class of medications called serotonin modulators. It works by increasing the amount of serotonin, a natural substance in the brain that helps maintain mental balance.
Read the full MedlinePlus article ↗- Trazodone is FDA-approved to treat major depressive disorder — that's clinical depression — in adults. It's available as tablets (Trazodone HCl, Trazodone Hydrochloride) and as an...
- Yes, and this actually matters. You should take it shortly after a meal or light snack — not on an empty stomach. Food changes how your body absorbs it, so taking it consistently w...
- Drowsiness is one of the most common side effects, and it's not unusual to feel it, especially when you first start or when your dose goes up. Your prescriber may suggest taking mo...
- It's best to avoid alcohol while on trazodone. Trazodone can make the effects of alcohol — and other sedating substances — much stronger than normal. That combination can cause exc...
Patient education
Supplement & herbal interactions
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
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Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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Phosphoric acid is a weak mineral acid used in medicines as a buffer and pH adjuster. It helps stabilize the product and control its acidity level.
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Propyl gallate is a synthetic antioxidant derived from gallic acid. It prevents oils and fats in the medicine from oxidizing and spoiling, helping the product stay stable and effective during storage.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
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UNII 506T60A25R
Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
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Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
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Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
9 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $1.541 | $462.33 / 300 ml |
| Medicaid paysCMS SDUD · 12 mo | $1.63 | $490.02 / 300 ml |
| Medicare drug plans payPart D · Q2 2026 | $1.65 | $495.33 / 300 ml |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Raldesy Tm 10 mg/mLthis 30698-0455-01 | Validus | 300 ml | $1.541 | — | Availability likely | — |
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⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 8133893 ↗ | Drug substance | — | Mar 13, 2029 |
Is there a generic version of RALDESY 10 MG/ML SOLUTION?
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🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 30698-0455-01 You're viewing this | 300 mL in 1 BOTTLE (30698-455-01) | $1.54 / mL | $462.33 | 2024-11-26 | Active |
| 30698-0455-02 | 150 mL in 1 BOTTLE (30698-455-02) | $2.45 / mL | $367.76 | 2024-11-26 | Active |
| 30698-0455-03 | 150 mL in 1 BOTTLE, GLASS (30698-455-03) | — | — | 2024-11-26 | Active |
| 30698-0455-04 | 300 mL in 1 BOTTLE, GLASS (30698-455-04) | — | — | 2024-11-26 | Active |
This pack has the lowest per-mL cost of the 2 priced pack sizes ($1.54 NADAC).
This pack accounts for about 27% of this product's recent Medicaid fills; most go to the 15 ml pack. See all packs ↓
Pack size FAQ
What quantity is in NDC 30698-0455-01?
What is the difference between NDC 30698-0455-01 and NDC 30698-0455-02?
What NDC number is used to bill for this package of RALDESY TM TRAZODONE HYDROCHLORIDE ORAL 10 mg/mL Solution?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: SUICIDAL THOUGHTS and BEHAVIORS 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 [see Warnings and Precautions (5.1) ] . RALDESY is not approved for use in pediatric patients [see Use in Specific Populations (8.4) ] .
WARNING: SUICIDAL THOUGHTS and BEHAVIORS See full prescribing information for complete boxed warning. Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients. Closely monitor for clinical worsening and emergence of suicidal thoughts and behaviors ( 5.1 ).
RALDESY is not approved for use in pediatric patients ( 8.4 ).
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE RALDESY TM is indicated for the treatment of major depressive disorder (MDD) in adults. RALDESY is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of major depressive disorder (MDD) in adults ( 1 ).
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Starting dosage: 150 mg orally in divided doses daily. May be increased by 50 mg per day every three to four days. Maximum dosage: 400 mg per day in divided doses ( 2.1 ). Administer RALDESY shortly after a meal or light snack ( 2.1 ). When discontinuing RALDESY, gradually reduce dose ( 2.5 ).
2.1Recommended Dosage 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 an tolerance. Occurrence of drowsiness may require the administration of a major portion of the daily dose at bedtime or a reduction of dosage [see Dosage and Administration (2.5) ] The dose may be increased by 50 mg daily every 3 to 4 days.
The maximum recommended dosage for outpatients usually should not exceed 400 mg daily in divided doses. Inpatients (i.e., more severely depressed patients) may be given up to, but not in excess, of 600 mg daily in divided doses. Administer RALDESY orally after a meal or light snack [see Clinical Pharmacology (12.3) ].
2.2Screen for Bipolar Disorder Prior to Starting RALDESY Prior to initiating treatment with RALDESY or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions (5.7) ].
2.3Switching to or from Monoamine Oxidase Inhibitor Antidepressant At least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI) antidepressant and initiation of RALDESY. In addition, at least 14 days must elapse after stopping RALDESY before starting an MAOI antidepressant [see Contraindications (4) , Warnings and Precautions (5.2) ].
2.4Dosage Recommendations for Concomitant Use with Strong CYP3A4 Inhibitors or Inducers Coadministration with Strong CYP3A4 Inhibitors Consider reducing RALDESY dose based on tolerability when RALDESY is coadministered with a strong CYP3A4 inhibitor [see Drug Interactions (7.1) ]. Coadministration with Strong CYP3A4 Inducers Consider increasing RALDESY dose based on therapeutic response when RALDESY is coadministered with a strong CYP3A4 inducer [see Drug Interactions (7.1) ].
2.5Discontinuation of Treatment with RALDESY Adverse reactions may occur upon discontinuation of RALDESY [see Warnings and Precautions (5.8) ]. Gradually reduce the dosage rather than stopping RALDESY abruptly whenever possible.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS RALDESY (10 mg/mL) Oral Solution: Clear, colorless solution Oral solution: 10 mg/mL
⛔ Contraindications ▾
4 CONTRAINDICATIONS 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 [see Warnings and Precautions (5.2) , Drug Interactions (7.1) ]. Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within 14 days of stopping MAOIs ( 4 ).
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents (e.g., SSRI, SNRI, triptans), but also when taken alone. If it occurs, discontinue RALDESY and initiate supportive treatment ( 5.2 ). Cardiac Arrhythmias: Increases the QT interval.
Avoid use with drugs that also increase the QT interval and in patients with risk factors for prolonged QT interval ( 5.3 ). Orthostatic Hypotension and Syncope: Warn patients of risk and symptoms of hypotension ( 5.4 ). Increased Risk of Bleeding: Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), other antiplatelet drugs, warfarin, and other anticoagulants may increase this risk ( 5.5 ).
Priapism: Cases of painful and prolonged penile erections and priapism have been reported. Immediate medical attention should be sought if signs and symptoms of prolonged penile erections or priapism are observed ( 5.6 ). Activation of Mania or Hypomania: Screen for bipolar disorder and monitor for mania or hypomania ( 5.7 ).
Potential for Cognitive and Motor Impairment: Has potential to impair judgment, thinking, and motor skills. Advise patients to use caution when operating machinery ( 5.9 ). Angle-Closure Glaucoma: Avoid use of antidepressants, including RALDESY, in patients with untreated anatomically narrow angles.
( 5.10 ).
5.1Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and over 4,500 pediatric patients, the incidence of suicidal thoughts and behaviors in antidepressant-treated patients age 24 years and younger was greater than in placebo-treated patients. There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied.
There were differences in absolute risk of suicidal thoughts and behaviors across the different indications, with the highest incidence in patients with MDD. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1,000 patients treated are provided in Table 1. Table 1: Risk Differences of the Number of Cases of Suicidal Thoughts or Behaviors in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and Adult Patients Age Range (years) Drug-Placebo Difference in Number of Patients of Suicidal Thoughts or Behaviors per 1,000 Patients Treated Increases Compared to Placebo <18 14 additional patients 18-24 5 additional patients Decreases Compared to Placebo 25-64 1 fewer patient ≥65 6 fewer 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.
However, there is substantial evidence from placebo-controlled maintenance trials in adults with MDD that antidepressants delay the recurrence of depression and that depression itself is a risk factor for suicidal thoughts and behaviors. 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.
5.2Serotonin Syndrome 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 seroton…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Suicidal Thoughts and Behaviors in Pediatric and Young Adults Patients [see Boxed Warning and Warnings and Precautions (5.1) ] Serotonin Syndrome [see Warnings and Precautions (5.2) ] Cardiac Arrythmias [see Warnings and Precautions (5.3) ] Orthostatic Hypotension and Syncope [see Warnings and Precautions (5.4) ] Increased Risk of Bleeding [see Warnings and Precautions (5.5) ] Priapism [see Warnings and Precautions (5.6) ] Activation of Mania or Hypomania [see Warnings and Precautions (5.7) ] Discontinuation Syndrome [see Warnings and Precautions (5.8) ] Potential for Cognitive and Motor Impairment [see Warnings and Precautions (5.9) ] Angle-Closure Glaucoma [see Warnings and Precautions (5.10) ] Hyponatremia [see Warnings and Precautions (5.11) ] Most common adverse reactions (incidence ≥ 5% and twice that of placebo) are: edema, blurred vision, syncope, drowsiness, fatigue, diarrhea, nasal congestion, weight loss ( 6.1 ).
To report SUSPECTED ADVERSE REACTIONS, contact Validus Pharmaceuticals LLC at 1-866-982-5438 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of RALDESY for the treatment of MDD in adults is based on studies of trazodone hydrochloride tablets. Below is a display of adverse reactions of trazodone hydrochloride tablets from those studies.
Table 2: Common Adverse Reactions Occurring in ≥ 2% of Trazodone hydrochloride Tablets -treated Patients and Greater than the Rate of Placebo-Treated Patients as Observed in Controlled Clinical Studies Inpatients Outpatients Trazodone hydrochloride N=142 Placebo N=95 Trazodone hydrochloride N=157 Placebo N=158 Allergic Skin Condition/Edema 3% 1% 7% 1% Autonomic Blurred Vision 6% 4% 15% 4% Constipation 7% 4% 8% 6% Dry Mouth 15% 8% 34% 20% Cardiovascular Hypertension 20% 1% 1% * Hypotension 7% 1% 4% 0 Syncope 3% 2% 5% 1% CNS Confusion 5% 0 6% 8% Decreased Concentration 3% 2% 1% 0 Disorientation 2% 0 * 0 Dizziness/Light-Headedness 20% 5% 28% 15% Drowsiness 24% 6% 41% 20% Fatigue 11% 4% 6% 3% Headache 10% 5% 20% 16% Nervousness 15% 11% 6% 8% Gastrointestinal Abdominal/Gastric Disorder 4% 4% 6% 4% Diarrhea 0 1% 5% 1% Nausea/Vomiting 10% 1% 13% 10% Musculoskeletal Aches/Pains 6% 3% 5% 3% Neurological Incoordination 5% 0 2% * Tremors 3% 1% 5% 4% Other Eyes Red/Tired/Itching 3% 0 0 0 Head Full-Heavy 3% 0 0 0 Malaise 3% 0 0 0 Nasal/Sinus Congestion 3% 0 6% 3% Weight Gain 1% 0 5% 2% Weight Loss * 3% 6% 3% Other adverse reactions occurring at an incidence of <2% with the use of trazodone hydrochloride in the controlled clinical studies: akathisia, allergic reaction, anemia, chest pain, delayed urine flow, early menses, flatulence, hallucinations/delusions, hematuria, hypersalivation, hypomania, impaired memory, impaired speech, impotence, increased appetite, increased libido, increased urinary frequency, missed periods, muscle twitches, numbness, paresthesia, retrograde ejaculation, shortness of breath, and tachycardia/palpitations.
Occasional sinus bradycardia has occurred in long-term studies.
6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of trazodone hydrochloride tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure: Blood and lymphatic system disorders: hemolytic anemia, leukocytosis Cardiac disorders: cardiospasm, congestive heart failure, conduction block, orthostatic hypotension and syncope, palpitations, bradycardia, atrial fibrillation, myocardial infarction, cardiac arre…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS CNS Depressants: RALDESY may enhance effects of alcohol, barbiturates, or other CNS depressants ( 7 ). CYP3A4 Inhibitors: Consider RALDESY dose reduction based on tolerability ( 2.5 , 7 ). CYP3A4 Inducers: Increase in RALDESY dosage may be necessary ( 2.5 , 7 ).
Digoxin or Phenytoin: Monitor for increased digoxin or phenytoin serum levels ( 7 ). Warfarin: Monitor for increased or decreased prothrombin time ( 7 ). Table 3 displays clinically significant drug Interactions with RALDESY.
Table 3: Clinically Significant Drug Interactions with RALDESY Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: The concomitant use of MAOIs and serotonergic drugs including RALDESY increases the risk of serotonin syndrome. Intervention: RALDESY is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [see Contraindications (4) , Dosage and Administration ( 2.3 , 2.4) , and Warnings and Precautions (5.2) ]. Other Serotonergic Drugs Clinical Impact: The concomitant use of serotonergic drugs, including RALDESY and other serotonergic drugs increases the risk of serotonin syndrome.
Intervention: 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 [see Warnings and Precautions (5.2) ]. Antiplatelet Agents and Anticoagulants Clinical Impact: Serotonin release by platelets plays an important role in hemostasis.
The concurrent use of an antiplatelet agent or anticoagulant with RALDESY may potentiate the risk of bleeding. Intervention: 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 [see Warnings and Precautions (5.5) ].
Strong CYP3A4 Inhibitors Clinical Impact: The concomitant use of RALDESY and strong CYP3A4 inhibitors increased the exposure of trazodone compared to the use of RALDESY alone. Intervention: 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 [see Dosage and Administration (2.5) , Warnings and Precautions (5.3) ]. Strong CYP3A4 Inducers Clinical Impact: The concomitant use of RALDESY and strong CYP3A4 inducers decreased the exposure of trazodone compared to the use of RALDESY alone.
Intervention: Patients should be closely monitored to see if there is a need for an increased dose of RALDESY when taking CYP3A4 inducers [see Dosage and Administration (2.5) ]. Digoxin and Phenytoin Clinical Impact: Digoxin and phenytoin are narrow therapeutic index drugs. Concomitant use of RALDESY can increase digoxin or phenytoin concentrations.
Intervention: Measure serum digoxin or phenytoin concentrations before initiating concomitant use of RALDESY. Continue monitoring and reduce digoxin or phenytoin dose as necessary. Central Nervous System (CNS) Depressants Clinical Impact: RALDESY may enhance the response CNS depressants.
Intervention: Patients should be counseled that RALDESY may enhance the response to alcohol, barbiturates, and other CNS depressants. QT Interval Prolongation Clinical Impact: Concomitant use of drugs that prolong the QT interval may add to the QT effects of RALDESY and increase the risk of cardiac arrhythmia. Intervention: Avoid the use of RALDESY in combination with other drugs known to prolong QTc [see Warnings and Precautions (5.3) ] .
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy 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/ . Risk Summary Published prospective cohort studies, case series, and case reports over several decades with trazodone hydrochloride tablets use in pregnant women have not identified any drug-associated risks of major birth defects, miscarriage, or other adverse maternal or fetal outcomes (see Data) .
There are risks associated with untreated depression in pregnancy (see Clinical Considerations ) . 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/m 2 basis. There was also an increase in congenital anomalies in the rabbit at approximately 7.3 to 22 times the MRHD on a mg/m 2 basis (see Data) .
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations Disease-associated maternal and/or embryofetal risk Women who discontinue antidepressants during pregnancy are more likely to experience a relapse of major depression than women who continue antidepressants. This finding is from a prospective, longitudinal study of 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. Consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum.
Data Human Data While available studies cannot definitively establish the absence of risk, published data from prospective cohort studies, case series, and case reports over several decades have not identified an association with trazodone use during pregnancy and major birth defects, miscarriage, or other adverse maternal or fetal outcomes. All available studies have methodological limitations, including small sample size and inconsistent comparator groups. Animal Data No teratogenic effects were observed when trazodone was given to pregnant rats and rabbits during the period of organogenesis at oral doses up to 450 mg/kg/day.
This dose is 11 and 22 times, in rats and rabbits, respectively, the maximum recommended human dose (MRHD) of 400 mg/day in adults on a mg/m 2 basis. Increased fetal resorption and other adverse effects on the fetus in rats at 7.3 to 11 times the MRHD and increase in congenital anomalies in rabbits at 7.3 to 22 times the MRHD on a mg/m 2 basis were observed. No further details on these studies are available.
8.2Lactation Risk Summary Data from published literature report the transfer of trazodone into human milk. There are no data on the effect of trazodone on milk production. Limited data from postmarketing reports have not identified an association of adverse effects on the breastfed child.
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.
8.4Pediatric Use Safety and effectiveness of RALDESY in the pediatric patients have not been established. Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric patients [see Boxed Warning , Warnings and Preca…
🆘 Overdosage ▾
10 OVERDOSAGE Death from overdose has occurred in patients ingesting trazodone and other CNS depressant drugs concurrently (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 1-888-222-1222 or a medical toxicologist for additional overdose management recommendations.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action The mechanism of trazodone’s antidepressant action is unclear, but is thought to be related to its enhancement of serotonergic activity in the CNS. Trazodone is both a selective serotonin reuptake inhibitor (SSRI) and a 5HT2 receptor antagonist and the net result of this action on serotonergic transmission and its role in trazodone’s antidepressant effect is unknown.
12.2Pharmacodynamics Preclinical studies have shown that trazodone selectively inhibits neuronal reuptake of serotonin (Ki = 367 nM) and acts as an antagonist at 5-HT-2A (Ki = 35.6 nM) serotonin receptors. Trazodone is also an antagonist at several other monoaminergic receptors including 5-HT2B (Ki = 78.4 nM), 5-HT2C (Ki = 224 nM), α1A (Ki = 153 nM), α2C (Ki = 155 nM) receptors and it is a partial agonist at 5- HT1A (Ki = 118 nM) receptor. Trazodone antagonizes alpha 1-adrenergic receptors, a property which may be associated with postural hypotension.
12.3Pharmacokinetics No clinically significant difference in pharmacokinetics of trazodone was observed between RALDESY and immediate-release trazodone hydrochloride tablet administered under fed conditions. Absorption Peak plasma levels occur approximately one hour after administration under fed conditions. Effect of Food Ingestion of a high-fat meal with RALDESY lowers mean C max of trazodone by 31% and increases mean AUC by 8%.
Median T max was similar between fed and fasted conditions. Distribution Trazodone is 89% to 95% protein bound in vitro at concentrations attained with therapeutic doses in humans. Metabolism In vitro studies in human liver microsomes show that trazodone is metabolized, via oxidative cleavage, to an active metabolite, m-chlorophenylpiperazine (mCPP) by CYP3A4.
Other metabolic pathways that may be involved in the metabolism of trazodone have not been well characterized. Trazodone is extensively metabolized; less than 1% of an oral dose is excreted unchanged in the urine. Elimination The average terminal elimination half-life of RALDESY under fed state is 18 hours.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied RALDESY TM contains 10 mg/mL of trazodone hydrochloride. It is a clear, colorless solution and is supplied as: 150 mL white, opaque, high-density polyethylene (HDPE) bottle NDC 30698-455-02 with child-resistant cap along with a 10 mL calibrated oral dosing syringe and bottle adapter. 300 mL white, opaque, high-density polyethylene (HDPE) bottle NDC 30698-455-01 with child-resistant cap along with a 10 mL calibrated oral dosing syringe and bottle adapter.
The bottle, bottle adapter and the dosing syringe are placed in a carton. Storage and Handling Store at 20°C to 25°C (68°F to 77°F). Excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Protect from light. Discard any unused RALDESY remaining in the bottle 30 days after first opening the bottle.
📋 Description ▾
11 DESCRIPTION RALDESY contains trazodone hydrochloride, a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist. Trazodone hydrochloride is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1- piperazinyl]propyl]-1,2,4-triazolo [4,3-a]pyridin-3(2 H )-one hydrochloride. It is a white odorless crystalline powder which is freely soluble in water.
The structural formula is represented as follows: Molecular Formula: C 19 H 22 CIN 5 O • HCL Molecular Weight: 408.33 RALDESY Oral Solution: Each mL contains 10 mg of Trazodone Hydrochloride, USP equivalent to 9.1 mg of trazodone base. The following inactive ingredients: disodium edetate, glycerin, ortho phosphoric acid, propyl gallate, propylene glycol, purified water, sodium benzoate,sorbitol, and sucralose. The pH of the oral solution is 3.8 to 4.8. "Image Description"
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Suicidal Thoughts and Behaviors Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dosage is adjusted up or down and instruct them to report such symptoms to the healthcare provider [ see Box Warning and Warnings and Precautions (5.1) ]. Dosage and Administration Advise patients that RALDESY should be taken shortly after a meal or light snack.
Advise patients regarding the importance of following dosage titration instructions [see Dosage and Administration (2) ] . Serotonin Syndrome Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of RALDESY with other serotonergic drugs including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John’s Wort, and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid).
Patients should contact their health care provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome [see Warnings and Precautions (5.2) and Drug Interactions (7) ] . Increased Risk of Bleeding Inform patients about the concomitant use of RALDESY with aspirin, NSAIDs, other antiplatelet drugs, warfarin, or other anticoagulants because the combined use of drugs that interfere with serotonin reuptake and these medications has been associated with an increased risk of bleeding. Advise them to inform their health care providers if they are taking or planning to take any prescription or over-the-counter medications that increase the risk of bleeding [see Warnings and Precautions (5.5) ] .
Activation of Mania or Hypomania Advise patients and their caregivers to observe for signs of activation of mania/hypomania and instruct them to report such symptoms to the healthcare provider [see Warnings and Precautions (5.7) ]. Discontinuation Syndrome Advise patients not to abruptly discontinue RALDESY and to discuss any tapering regimen with their healthcare provider. Adverse reactions can occur when RALDESY is discontinued [see Warnings and Precautions (5.8) ].
Concomitant Medications Advise patients to inform their health care providers if they are taking, or plan to take any prescription or over-the-counter medications since there is a potential for interactions [see Drug Interactions (7.1) ]. Pregnancy Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during therapy with RALDESY. Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to RALDESY during pregnancy [see Use in Special Populations (8.1) ].
Manufactured for and distributed by: Validus Pharmaceuticals LLC Parsippany, NJ 07054
💬 Medication Guide ▾
MEDICATION GUIDE RALDESY TM (ral DEH see) (trazodone hydrochloride) oral solution 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 within 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 as scheduled.
Call your healthcare provider between visits as needed, especially if you are worried about symptoms. Call a healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you: • attempts to commit suicide • acting on dangerous impulses • acting aggressive or violent • thoughts about suicide or dying • new or worse depression • a new or worse anxiety or panic attacks • feeling agitated, restless, angry, or irritable • trouble sleeping • an increase in activity or talking more than what is normal for you • other unusual changes in behavior and mood See “What are the possible side effects of RALDESY?” for more information about side effects.
What is RALDESY? RALDESY is a prescription medicine used in adults to treat major depressive disorder (MDD). It is not known if RALDESY is safe and effective for use in children.
Who should not take RALDESY? Do not take RALDESY if you: • are taking, or have stopped taking within the last 14 days, a medicine called Monoamine Oxidase Inhibitor (MAOI), including the antibiotic linezolid and intravenous methylene blue Ask your healthcare provider or pharmacist is you are not sure if you take an MAOI, including the antibiotic linezolid or intravenous blue. Do not start taking an MAOI for at least 14 days after you stop treatment with RALDESY.
Before taking RALDESY tell your healthcare provider about all of your medical conditions, including if you: • have or have a family history of heart problems, including fast or slow heartbeat, or changes in the electrical activity of your heart (QT prolongation) • have ever had a heart attack • have or have had bleeding problems • are male and have conditions that may cause a prolonged or painful erection (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.
It is not known if RALDESY will harm your unborn baby. Talk to your healthcare provider about the risks to you or your unborn baby if you take RALDESY during pregnancy. ◦ Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with RALDESY. ◦ There is a pregnancy registry for females who are exposed to RALDESY during pregnancy. The purpose of this registry is to collect information about the health of females exposed to RALDESY and their baby.
If you become pregnant during treatment with RALDESY, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants. You can register by calling 1-866-961-2388 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants…