SUICIDALITY IN CHILDREN AND ADOLESCENTS
Antidepressants increase the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of DESYREL or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be 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. DESYREL is not approved for use in pediatric patients. (See WARNINGS and PRECAUTIONS: Pediatric Use).
Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in these trials.
DESYREL (trazodone hydrochloride) is an antidepressant chemically unrelated to tricyclic, tetracyclic, or other known antidepressant agents.
DESYREL is indicated for the treatment of depression. The efficacy of DESYREL 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 two 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.
Published Studies Related to Desyrel (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. 
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 Desyrel (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).
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
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.
Comparative Bioavailability Study of Extended-release and Immediate-release Trazodone in Healthy Adult Volunteers [Completed]
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.
Reports of Suspected Desyrel (Trazodone) Side Effects
Confusional State (4),
Drug Ineffective (3),
Weight Increased (3),
Chest Pain (3),
Toxicity TO Various Agents (3),
Convulsion (3), more >>
PATIENT REVIEWS / RATINGS / COMMENTS
Based on a total of 14 ratings/reviews, Desyrel has an overall score of 6. The effectiveness score is 7.86 and the side effect score is 6.14. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
Desyrel review by 30 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Highly Effective|
|Side effects:|| || Moderate Side Effects|
|Condition / reason:|| || Fibromyalgia|
|Dosage & duration:|| || 5 mg taken 1 at bed time for the period of 1 month|
|Other conditions:|| || tiredness, pain all over, migraines|
|Other drugs taken:|| || zoloft|
|Benefits:|| || The medication took all my simptoms away completely!|
|Side effects:|| || dry mouth. Lucid,vivid dreams. I cut the pill in fourths. A fourth of the pill still helped me sleep but, the wild dreams stopped.|
|Comments:|| || Before taking this medication I was in constant pain. Every muscle in my body hurt. Legs, Back, arms. All my joints felt like they were being nawed away and had burning pain in ever muscle. I had a Migraine ever minute of every day. I was constantly exsausted. After taking it for one week, I felt like a new person. For me this was a miracle drug. I stopped taking it after a month and was pain free.
Since then, When ever my Fibromyalgia flares up... I take it for a week or more and it puts me back on a deep sleep pattern. I don't have to take it all the time. Just when I need it.|
Desyrel review by 47 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Considerably Effective|
|Side effects:|| || Severe Side Effects|
|Condition / reason:|| || Insomnia|
|Dosage & duration:|| || 100 mg taken at night, once a day for the period of 5 years|
|Other conditions:|| || Restless Legs|
|Other drugs taken:|| || Mirapex|
|Benefits:|| || Held me in a deep sleep and my muscle pain subsided. |
|Side effects:|| || Grooginess in the morning. Low libido. Water retention with edema. I didn't realize it was the medication that caused the edena until I quit taking it. When I started back on the medication I immediately swelled with edema.
Initially, it was working well, then I developed weight gain and terrible edema in my ankles and legs. Sometimes it didn't make me sleepy and I doubled my dose. It literally made me green with nausea, but I was able to sleep. |
|Comments:|| || Lighter doses didn't work. My doctor gradually upped my dose until it was high enough to be effective. After 5 years, I decided to quit taking the medicine cold turkey. This was five months ago because of the low libido. I was a basket case, but it was out of my system in about four days. I later found out that you should go off it gradually with a doctor's supervision. Quitting, as I did, could cause you to be suicidal. It certainly was very difficult on me.
During my time drug free, I developed anger issues, depression and wanted to hurt myself. My sleep became light again, causing muscle pain from lack of rest.
After several months drug free, I restarted the medication for insomnia. Immediately my ankles and legs swelled greatly with edema. The water retention and edema is still there even after several days of discontinuing the medication. Maybe this is because I took a high dosage. I plan to go back to my doctor and try something different.|
Desyrel review by 63 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Moderately Effective|
|Side effects:|| || Severe Side Effects|
|Condition / reason:|| || Insomnia|
|Dosage & duration:|| || 50 mg. taken nightly for the period of 1 week|
|Other conditions:|| || Depression, anxiety|
|Other drugs taken:|| || Wellbutrin, Effexor|
|Benefits:|| || There were few benefits. It still took me a long time to go to sleep, about two hours. Some nights it didn't work at all. When dosage was increased the side effects became unacceptable. I took the medication for a week and then could not stand it anymore. It was preferable to go without sleep than to take this drug.|
|Side effects:|| || Dizziness, dry mouth, extremely dry skin, highly increased urination, memory problems.|
|Comments:|| || I started with a half pill, then it was increased to 1 due to ineffectiveness. It was increased to 1 1/2, then 2 pills. |
Page last updated: 2013-02-10