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 Associationís 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)
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).
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
Comparison of the Pharmacokinetics of Three Generic Medications and Their Respective Brand Preparations [Recruiting]
Generic describes a pharmaceutical product that does not have a brand name or trademark.
Generic medications should be the equivalent of brand medications. Only their price should
be different. The active ingredient of the generic medication has to be within a window of
80 to 125% of the original in the blood. There are reports that this standard is not always
followed after the medication has been on the market. Indeed, it was observed that some
patients previously stable on original medications relapsed when switched to a generic.
Several factors could account for this problem. Such problems have been reported for
Pindolol, Quetiapine, and Trazodone. Some properties of specific brands of the generics and
the original brands will be examined for these three medications. The three original
medications used in this study are the Visken, the Seroquel, and the Desyrel. The three
generics are the Teva-pindolol, the Teva-Quetiapine, and the Teva-Trazodone. They are all
available on the Canadian market by prescription.
A Clinical Study of Trazodone Hydrochloride Prolonged-Release Tablets for Treatment of Depression [Recruiting]
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