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Trazodone (Trazodone Hydrochloride) - Summary


Suicidality and Antidepressant Drugs

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of trazodone hydrochloride or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Trazodone hydrochloride is not approved for use in pediatric patients. (See Warnings: Clinical Worsening and Suicide Risk , Precautions: Information for Patients , and Precautions: Pediatric Use )



Hydrochloride Tablets USP
Revised: August 2007
Rx only

Trazodone hydrochloride is an antidepressant chemically unrelated to tricyclic, tetracyclic, or other known antidepressant agents. Trazodone hydrochloride is a triazolopyridine derivative designated as 2-[3-[4-(m -Chlorophenyl)-1-piperazinyl] propyl] s -triazolo[4,3- a ]-pyridin-3(2 H)-one monohydrochloride. It is a white orderless crystalline powder which is freely soluble in water.

Trazodone hydrochloride is indicated for the treatment of depression. The efficacy of trazodone has been demonstrated in both inpatient and outpatient settings and for depressed patients with and without prominent anxiety. The depressive illness of patients studied corresponds to the Major Depressive Episode criteria of the American Psychiatric Association’s Diagnostic and Statistical Manual, III.a

Major Depressive Episode implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least four of the following eight symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigability, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicidal ideation or attempts.

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Published Studies Related to Trazodone

Trazodone for sleep disturbance during methadone maintenance: A double-blind, placebo-controlled trial. [2011.07.26]
BACKGROUND: To test whether trazodone, one of the most commonly prescribed medications for treatment of insomnia, improves subjective and/or objective sleep among methadone-maintained persons with sleep complaints, we performed a randomized, double-blind, placebo-controlled trial with 6-month follow-up... CONCLUSIONS: Trazodone did not improve subjective or objective sleep in methadone-maintained persons with sleep disturbance. Other pharmacologic and non-pharmacologic treatments should be investigated for this population with high rates of insomnia. Copyright (c) 2011 Elsevier Ireland Ltd. All rights reserved.

A pilot study of the efficacy and safety of paroxetine augmented with risperidone, valproate, buspirone, trazodone, or thyroid hormone in adult Chinese patients with treatment-resistant major depression. [2011]
To compare the efficacy and safety of augmenting paroxetine with risperidone, buspirone, valproate, trazodone, or thyroid hormone in patients with treatment-resistant depression (TRD), 225 patients with retrospectively and/or prospectively identified stage II TRD were randomly assigned to receive an 8-week treatment of paroxetine 20 mg/d augmented with risperidone 2 mg/d (n = 45), sodium valproate 600 mg/d (n = 39), buspirone 30 mg/d (n = 46), trazodone 100 mg/d (n = 47), or thyroid hormone 80 mg/d (n = 48)...

Dose proportionality of once-daily trazodone extended-release caplets under fasting conditions. [2010.12]
An extended-release trazodone HCl formulation, Trazodone Contramid OAD (TzCOAD), was developed as scored 150-mg and 300-mg caplets for once-daily administration. Dose proportionality of intact and bisected caplets (dose range, 75-375 mg) was evaluated in a single-dose, randomized, 5-way crossover study...

Effects on sleep stages and microarchitecture of caffeine and its combination with zolpidem or trazodone in healthy volunteers. [2009.07]
Caffeine is the world's most popular stimulant and is known to disrupt sleep... These data suggest that caffeine mimics some, but not all of the sleep disruption seen in insomnia and that its disruptive effects are differentially attenuated by the actions of sleep-promoting compounds with distinct mechanisms of action.

Short-term clarithromycin administration impairs clearance and enhances pharmacodynamic effects of trazodone but not of zolpidem. [2009.06]
The kinetic and dynamic interactions of 5 mg zolpidem and 50 mg trazodone with 500 mg clarithromycin (4 doses given over 32 h) were investigated in a 5-way double crossover study with 10 healthy volunteers. The five treatment conditions were: placebo + placebo; zolpidem + placebo; zolpidem + clarithromycin; trazodone + placebo; and trazodone + clarithromycin.

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Clinical Trials Related to Trazodone

The Association of 5-HT2A Polymorphism and Efficacy of Trazodone for Selective Serotonin Reuptake Inhibitor-Induced Sexual Function [Recruiting]
The aim of this study is to investigate the efficacy of trazodone in the treatment of selective serotonin reuptake inhibitor(s) associated sexual dysfunction. The secondary domains assessed were the relationship between 5-HT2A polymorphism and treatment efficacy.

Trazodone for Sleep Disorders in Alzheimer's Disease [Recruiting]
The purpose of this study is to determine whether trazodone is effective in the treatment of sleep disorders in Alzheimer's disease (AD).

A Clinical Study of Trazodone Hydrochloride Prolonged-Release Tablets for Treatment of Depression [Recruiting]

Trazodone for Sleep Disturbance in Early Alcohol Recovery [Completed]
This study is a randomized, double-blind clinical trial comparing trazodone (Desyrel) and placebo among sleep-disturbed, alcohol-dependent individuals shortly after discharge from an inpatient detoxification program. Subjects will undergo a baseline assessment and random assignment to trazodone or identical placebo for 12 weeks. All persons completing the alcohol detoxification at Stanley Street Treatment and Resources (SSTAR) will be screened. (SSTAR of Rhode Island provides detoxification services to non/underinsured persons of Rhode Island.)

Trazodone and Its Augmentation With Pregabalin in the Treatment of Fibromyalgia [Recruiting]
The study has a double purpose: a first phase intends to assess the effectiveness and tolerability of trazodone, an antidepressant with sedative and sleep-promoting properties, in the treatment of fibromyalgia; a second phase intends to evaluate if the addition of pregabalin to patients who have shown a partial response to trazodone additionally improves fibromyalgia symptomatology.

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Based on a total of 16 ratings/reviews, Trazodone has an overall score of 7.75. The effectiveness score is 8.62 and the side effect score is 7.75. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.

Trazodone review by 54 year old female patient

Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Mild Side Effects
Treatment Info
Condition / reason:   depression/difficulty sleeping
Dosage & duration:   50mg/night taken nightly for the period of three years
Other conditions:   hay fever
Other drugs taken:   over-the-counter antihistamine
Reported Results
Benefits:   I took it before bed, and it helped me get to sleep. It also helped me cope during a difficult time emotionally.
Side effects:   The drug is an anti-depressant. The side effect was sleepiness, which is also therapeutic when taken at night.
Comments:   Ongoing treatment for several years with 50 mg at bedtime.


Trazodone review by 27 year old female patient

Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Mild Side Effects
Treatment Info
Condition / reason:   insomnia
Dosage & duration:   50mg taken nightly for the period of 4 years
Other conditions:   none
Other drugs taken:   none
Reported Results
Benefits:   relief of insomnia
Side effects:   grogginess in the morning
Comments:   50mg nightly


Trazodone review by 61 year old male patient

Overall rating:  
Effectiveness:   Ineffective
Side effects:   Extremely Severe Side Effects
Treatment Info
Condition / reason:   insomnia
Dosage & duration:   50 mg taken once at bedtime for the period of 5 days
Other conditions:   leukemia in re-mission/high white blood cell counts
Other drugs taken:   vicodin/valium/codine/attivan/temazipam/gleevec
Reported Results
Benefits:   it was not good,had to dismiss previous primary doctor&ortopedic surgeon as my best interests were not of thier concern,I now have a new primary doctor&orthopedic surgeon as both knew about fractured clavicle/shouder rotocuff completely ripped,i now am faced with some life changing desisions with a scambleled mind,would like to warn about some docters that address,medi cal&medicare patients
Side effects:   after emergency of going cold turkey,on previous meds,new docter advised me to use only,vicodin,attvan,gleevec,effecsor,aspiran.I now feel like i have lost my mind,after taking 50 mg of trazodone nightly.
Comments:   ongoing daily reports to new doctor,with a third party involed,in any decisions, please desregard any misspelling-confused easily now,trazadone made me sick to my stomach,appetite down,all my body allmost in an upheaval,can not sleep,hard to eat,sleep depraveted and know off my vitamins too.I feel like i have jumped out of the pan into the fire.

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Page last updated: 2013-02-10

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