BOXED WARNING SECTION
WARNING: 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 tablets 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 tablets are not approved for use in pediatric patients [see Warnings and Precautions and Patient Counseling Information].
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TRAZODONE SUMMARY
Trazodone hydrochloride is a triazolopyridine. It is a white, odorless crystalline powder which is freely soluble in water.
Chemical Name: 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-1,2,4-triazolo[4,3-a]pyridin-3(2H)-one hydrochloride.
Trazodone hydrochloride tablets USP are indicated for the treatment of major depressive disorder (MDD) in adults. The efficacy of trazodone hydrochloride tablets USP has been established in trials with the immediate release formulation of trazodone [see Clinical Studies].
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NEWS HIGHLIGHTS
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.
Clinical Trials Related to Trazodone
Comparison of Quetiapine and Trazodone Treatment for Insomnia in Dually Diagnosed Veterans [Enrolling by invitation]
This is a pilot comparative effectiveness study designed to determine whether trazodone is
as effective as quetiapine for treatment of insomnia in veterans with a history of addiction
and mental health issues. The study will have two concurrent phases (parts); first an
acceptability determination phase, to determine whether and why (or why not) veterans
already taking quetiapine are willing to try an alternative to quetiapine for sleep; and
second, a randomized trial phase which will test whether staying on quetiapine has any
advantage over switching to trazodone. The purpose of the first phase will be a) to document
the proportions of patients and physicians who are willing to agree to such a switch, b) to
characterize sociodemographic and clinical characteristics of potentially eligible subjects
associated with a willingness to switch from quetiapine to trazodone and c) to record the
reasons given why patients and their prescribers are (or are not) willing to accept a switch
from quetiapine to trazodone. It will also function to provide some educational background
to patients and a reminder to providers about the potential severe side-effects of
quetiapine, and will thus facilitate clinical informed consent for the clinical trial phase
of the study. Completion of the first part of the study will also serve as the screening
component for part II. Part II includes, first, obtaining written informed consent from
eligible subjects, and then randomly assigning them to continue quetiapine or to be switched
to trazodone in open-label "real world" fashion for the duration of 4 weeks, followed by
another four weeks of open, non-randomized follow- up. The purpose of the second part of the
study is to determine if trazodone is an adequate substitute for quetiapine, primarily in
terms of treating insomnia. The investigators hypothesize that trazodone will not be
inferior to quetiapine in maintaining good quality of sleep measured by sleep scales (i. e.,
scores will not significantly worsen once switched). This study is open to Veterans in the
VA system only. Eligible subjects must have a history of "dual diagnosis" (i. e., a history
of addiction and mental illness).
A Study to Compare the Bioavailability of 300 mg Trazodone Hydrochloride Extended-release Caplets and 100 mg Trazodone Hydrochloride Immediate-release Tablets at Steady State [Completed]
The purpose of this study was to compare the pharmacokinetic profiles at steady state of the
test product, 300 mg trazodone hydrochloride (HCl) extended-release caplets (containing
Contramid®), when administered once daily, and the reference product, 100 mg trazodone HCl
immediate-release tablets (Apotex Corp.), when administered three times daily, for one week.
For this purpose, the rate and extent of absorption of trazodone and formation of
m-chlorophenylpiperazine (mCPP) after administration of multiple doses of up to 300 mg of
each of the two formulations was compared.
Trazodone for SSRI-sexual Dsyfunction [Completed]
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.
Comparative Bioavailability Study of Two Prototypes of Trazodone Controlled-release Products and Two Marketed Reference Products in Healthy Volunteers [Completed]
The objectives of this study were:
- to compare the pharmacokinetic profiles of two prototype controlled-release (CR)
trazodone hydrochloride (HCl) 300 mg tablets versus two reference products: Trittico®
AC (2 x 150 mg CR tablets) and Desyrel® (3 x 100 mg IR (immediate-release) tablets)
under fasting condition;
- to assess the controlled release properties of the two prototype formulations;
- to select a prototype formulation for further development;
- to validate the blood sampling schedule for future pivotal pharmacokinetic studies;
- to determine the appropriate sample size for pivotal studies based in the intra-subject
variability.
Trazodone for Sleep Disorders in Alzheimer's Disease [Completed]
The purpose of this study is to determine whether trazodone is effective in the treatment of
sleep disorders in Alzheimer's disease (AD).
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PATIENT REVIEWS / RATINGS / COMMENTSBased 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 | | | Rating |
| 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. |
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| | Trazodone review by 27 year old female patient | | | Rating |
| 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 |
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| | Trazodone review by 61 year old male patient | | | Rating |
| 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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