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 )
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TRAZODONE SUMMARY
Trazodone
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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NEWS HIGHLIGHTS
Published Studies Related to Trazodone
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.
Trazodone for sleep disturbance after alcohol detoxification: a double-blind, placebo-controlled trial. [2008.09]
BACKGROUND: Trazodone is a commonly prescribed off-label for sleep disturbance in alcohol-dependent patients, but its safety and efficacy for this indication is unknown... CONCLUSIONS: Trazodone, despite a short-term benefit on sleep quality, might impede improvements in alcohol consumption in the postdetoxification period and lead to increased drinking when stopped. Until further studies have established benefits and safety, routine initiation of trazodone for sleep disturbance cannot be recommended with confidence during the period after detoxification from alcoholism.
Trazodone for Sleep Disturbance After Alcohol Detoxification: A Double-Blind, Placebo-Controlled Trial. [2008.06.28]
Background: Trazodone is a commonly prescribed off-label for sleep disturbance in alcohol-dependent patients, but its safety and efficacy for this indication is unknown. Methods: We conducted a randomized, double-blind, placebo-control trial of low-dose trazodone (50 to 150 mg at bedtime) for 12 weeks among 173 alcohol detoxification patients who reported current sleep disturbance on a validated measure of sleep quality or during prior periods of abstinence...
Tinnitus treatment with Trazodone. [2007.05]
Tinnitus is a common symptom, defined as a sound perception in absence of a sound stimulus. AIM: Evaluate if Trazodone, an antidepressant drug, which modulates serotonin at central neuronal pathways, is effective in controlling tinnitus. STUDY DESIGN : Prospective, double blind, randomized, placebo-controlled... CONCLUSION: Trazodone was not efficient in controlling tinnitus in the patients evaluated under the doses utilized.
Clinical Trials Related to Trazodone
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.
Treatment of Neuroleptic Induced Acute Akathisia With Trazodone [Completed]
Agitation in Alzheimer's Disease [Completed]
Agitation affects 70 to 90 percent of patients with AD. Signs of agitation include verbal
and physical aggressiveness, irritability, wandering, and restlessness. These behaviors
often make caring for patients at home very difficult. Trazodone and haldol are two of the
most commonly prescribed drugs for agitation in AD patients. Behavior management, a non drug
approach, has been effective in reducing signs of agitation. Researchers have yet to compare
the effectiveness of drug versus non drug therapy to treat agitation in AD patients and
determine which is the best treatment. The Alzheimer's Disease Cooperative Study, with
funding from the National Institute on Aging, is conducting an agitation treatment program at
21 sites in 16 States. This study will assess which of the above treatments is most
effective.
Insomnia and Drug Relapse Risk [Recruiting]
The purposes of this study are:
1. to evaluate the relationship between subjective complaints of sleep and objective
measures of sleep quality, as measured through polysomnography, and
2. to evaluate the efficacy of trazodone, as compared to placebo, in individuals early in
methadone maintenance.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 12 ratings/reviews, Trazodone has an overall score of 7.17. The effectiveness score is 8.33 and the side effect score is 7.33. 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: | | Highly Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | insomnia |
| Dosage & duration: | | 25mg taken nightly for the period of 4 years |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | Sleeping through the night |
| Side effects: | | Grogginess in the morning |
| Comments: | | Nightly use, one hour before bed. |
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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: 2009-10-20
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