You should not stop using this medicine suddenly, or you could have unpleasant symptoms (such as dizziness, vomiting, agitation, sweating, confusion, numbness, tingling, or electric shock feelings). Trazodone is not approved for use in treating bipolar depression. Available as trazodone hydrochloride; dosage is expressed in terms of the salt. If drowsiness occurs, administer a major portion of the daily dosage at bedtime or reduce dosage. Some people may have a higher risk of having suicidal thoughts or actions. These include people who have or have a family history of bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.
It is very important that your doctor check your progress at regular visits, to allow for changes in your dose and to help manage any unwanted effects. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) such as aspirin, ibuprofen, naproxen, Advil, Aleve, Motrin, and others. Using an NSAID with trazodone may cause you to bruise or bleed easily. Overdose symptoms may include extreme drowsiness, vomiting, penis erection that is painful or prolonged, fast or pounding heartbeat, seizure (black-out or convulsions), or breathing that slows or stops. Keep using the medication as directed and tell your doctor if your symptoms do not improve.
6 Discontinuation of Treatment with Trazodone Hydrochloride Tablets
This list is not complete and many other drugs may interact with trazodone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. 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/m2 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/m2 basis were observed.
Drugs Affecting Hepatic Microsomal Enzymes
These may be symptoms of serious conditions called serotonin syndrome and neuroleptic malignant syndrome-like reactions. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body. For some teenagers and young adults, this medicine can increase thoughts of suicide. Tell your doctor right away if you start to feel more depressed or have thoughts about hurting yourself or others.
Does Trazodone interact with my other drugs?
Arrhythmias identified include isolated PVCs, ventricular couplets, tachycardia with syncope, and torsade de pointes. Postmarketing events, including torsade de pointes have been reported at doses of 100 mg or less with the immediate-release form of trazodone. Trazodone is not recommended for use during the initial recovery phase of myocardial infarction.
Additional dosage information:
- This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert).
- Discontinue treatment with trazodone and any concomitant serotonergic agents immediately if the above symptoms occur, and initiate supportive symptomatic treatment.
- Some mixtures of medications can lead to serious and even fatal consequences.
- Along with its needed effects, trazodone may cause some unwanted effects.
Gradually reduce the dosage rather than stopping trazodone hydrochloride tablets abruptly whenever possible. At least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI) antidepressant and initiation of trazodone hydrochloride tablets. In addition, at least 14 days must elapse after stopping trazodone hydrochloride tablets before starting an MAOI antidepressant see Contraindications (4), Warnings and Precautions (5.2). Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there.
- Peak plasma levels occur approximately one hour after dosing when trazodone hydrochloride is taken on an empty stomach or 2 hours after dosing when taken with food.
- Do not take other medicines unless they have been discussed with your doctor.
- Limited data from postmarketing reports have not identified and association of adverse effects on the breastfed child.
- Prior to initiating treatment with trazodone, screen patients for any personal or family history of bipolar disorder, mania, or hypomania see Dosage and Administration (2.3) .
- If you are pregnant, your name may be listed on a pregnancy registry to track the effects of trazodone on the baby.
- A prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy.
Trazodone has no effect on fertility in rats at doses up to 7.3 times the MRHD in adults on a mg/m2 basis. The estimated 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.
Trazodone hydrochloride tablets should be taken shortly after a meal or light snack. Trazodone hydrochloride tablets can be swallowed whole or administered as a half tablet by breaking the tablet along the score line. This medicine may cause some people to become drowsy or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert.
This medicine can cause some serious health issues
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 trazodone, screen patients for any personal or family history of bipolar disorder, mania, or hypomania see Dosage and Administration (2.3) . Medicines that interact with trazodone may either decrease its effect, affect how long it works, increase side effects, or have less of an effect when taken with trazodone. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed. Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders.
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. The mechanism of trazodone’s antidepressant action is not fully understood, 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. Data from published literature report the transfer of trazodone into human milk.
In humans, trazodone hydrochloride is absorbed after oral administration without selective localization in any tissue. When trazodone hydrochloride is taken shortly after ingestion of food, there may be an increase in the amount of drug absorbed, a decrease in maximum concentration and a lengthening in the time to maximum concentration. Peak plasma levels occur approximately one hour after dosing when trazodone hydrochloride is taken on an empty stomach or 2 hours after dosing when taken with food. Cases of priapism (painful erections greater than 6 hours in duration) have been reported in men receiving trazodone. Priapism, if not treated promptly, can result in irreversible damage to the erectile tissue.
50 mg Tablets, white to off white, round, biconvex, uncoated tablets debossed with “13” bisect “30” on one side and plain on other side. Along with its needed effects, trazodone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. This is not a complete list of side effects and others may occur.
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. Avoid drinking alcohol or taking illegal or recreational drugs while taking trazodone. Trazodone is mostly used for its sleep-inducing effects (an off-label indication) rather than as an antidepressant. Only generic forms are available which makes it a lot cheaper than some other sleep-inducing alternatives, and it is not classified as a controlled substance. Always consult your healthcare provider to ensure the information trazodone withdrawal: symptoms, timeline, treatment displayed on this page applies to your personal circumstances. Do not take trazodone with a monoamine oxidase (MAO) inhibitor (eg, isocarboxazid Marplan®, phenelzine Nardil®, selegiline Eldepryl®, tranylcypromine Parnate®).