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, Clinical Worsening and Suicide Risk, PRECAUTIONS, Information for Patients, 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.
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TRAZODONE SUMMARY
TRAZODONE HYDROCHLORIDE TABLETS, USP
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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TRAZODONE NEWS HIGHLIGHTS
Published Studies Related to Trazodone
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.
A comparative, randomized, double-blind study of trazodone prolonged-release and sertraline in the treatment of major depressive disorder. [2006.09]
CONCLUSIONS: This study showed that after 6 weeks, trazodone and sertraline were not different in reducing symptoms of depression and in producing disease remission. Tolerability profiles reflected the differing pharmacological properties of these antidepressants. Trazodone may be a therapeutic option in the treatment of patients with major depression showing prevalent sleep disturbances.
A comparative, randomised, double-blind study of trazodone prolonged-release and paroxetine in the treatment of patients with major depressive disorder. [2005.08]
CONCLUSIONS: This study showed that after a 6-week period trazodone and paroxetine are not different in reducing the symptoms of depression and, in many patients, in producing the remission of the illness. The known divergence in tolerability profile of the two medications, related to their differing pharmacological properties, was also confirmed. Trazodone may be of advantage in depressed patients with sleep difficulties.
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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TRAZODONE PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 10 ratings/reviews, Trazodone has an overall score of 8. The effectiveness score is 9 and the side effect score is 7.80. 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 36 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | sleeplessness associated with depression |
| Dosage & duration: | | 50 mg - I almost always broke in half taken as needed for sleep for the period of about six months |
| Other conditions: | | depression |
| Other drugs taken: | | fish oil and b-100 complex | | |
Reported Results |
| Benefits: | | It helped me sleep, which at the time was miraculous. |
| Side effects: | | Bad taste in mouth but the sleep was worth it. |
| Comments: | | If I could tell I was going to have a hard time sleeping, I was supposed to take the medecine about 45 minutes before going to bed. Sometimes it was hard to realize/remember to take it ahead of time like that, but it was so fast-acting that wasn't really a problem. I'm little, 5'2 and 120 lbs, and the doctor said it was okay to break them in half so I mostly did. After about fifteen minutes I would get drowsy and then I would get a nice night's sleep. This was incredibly valuable and it was no problem to go off the medication at the end of treatment because I was only taking it when I needed it anyway, only a couple times a week at the worst point. The halitosis might have actually made it easier to stop taking--I had to really want the sleep and be willing to put up with the foul taste in my mouth. But if I needed the sleep badly enough it was really worth it. |
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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 57 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Highly Effective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | fibromyalgia |
| Dosage & duration: | | 100mg at night taken nightly for the period of 4 weeks |
| Other conditions: | | depresssion |
| Other drugs taken: | | cymbalta | | |
Reported Results |
| Benefits: | | sleep |
| Side effects: | | terrible pain in my upper right back below ribs and right side. |
| Comments: | | The doctor does not believe I had this side effects because I took trazaone 2 weeks before I started the cymbalta. When I took the first trazadone this terrible pain begain. I tested not taking it and the pain almost completely subsided but was scared to completely stop. I did this 2 times. Then he started me on cymbalta. I had been on cymbalta for almost 2 weeks when he finally agreed I could stop the trazadone. By this time the cymbalta was in my system and I continue to have these back pains. Can anyone share with me |
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Page last updated: 2008-11-03
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