Product Specifications
| Specification | Details |
| Manufacturer / Brand | Rising Pharmaceuticals, Inc. |
| Manufacturer # / SKU | 64980067201 |
| NDC Number | 64980-672-01 |
| Active Ingredient | Trazodone Hydrochloride 50 mg |
| Application | Antidepressant / SARI |
| Dosage Form | Tablet (Scored) |
| Strength | 50 mg |
| Color / Shape | White / Round |
| Markings | “672” and “RL” |
| Packaging | Bottle of 100 Tablets |
| Storage Requirements | 20°C to 25°C (68°F to 77°F); protect from light |
Key Features
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Scored Tablet Design: The 50 mg tablet is scored, facilitating easy splitting for patients requiring a 25 mg starting dose or gradual titration.
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Dual Mechanism (SARI): Effectively inhibits serotonin reuptake while blocking 5 – HT-2 receptors, offering a balanced mood-stabilizing effect with lower rates of sexual dysfunction compared to standard SSRIs.
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Clinical Sedative Profile: Exceptionally effective for restoring sleep architecture in patients suffering from major depressive disorder (MDD) and comorbid insomnia.
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Non-Scheduled Substance: Provides a safe, non-habit-forming alternative to benzodiazepines for long-term sleep management.
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Optimized Bioavailability: Readily absorbed when taken orally, with the presence of food slightly increasing the total amount of drug absorbed and reducing peak plasma concentration.
Clinical Applications
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Major Depressive Disorder (MDD): Standard treatment for the relief of depression symptoms.
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Insomnia (Off-Label): Widely utilized in low doses (25 mg–100 mg) to treat persistent sleep disturbances.
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Anxiety Disorders: Often used as an adjunctive therapy to reduce symptoms of generalized anxiety.
⚠️ Usage Note: Trazodone should be taken shortly after a meal or a light snack to reduce the risk of dizziness or orthostatic hypotension.
⚠️ Black Box Warning: SUICIDALITY AND ANTIDEPRESSANT DRUGS. Monitor all patients—especially young adults and children—for clinical worsening or emergence of suicidal thoughts during the initial phase of treatment.
⚠️ Safety Alert: Seek immediate medical attention if priapism (a prolonged, painful erection) occurs. Patients with known heart disease should be monitored for potential arrhythmias or QT interval prolongation.
