Desyrel (Trazodone Hydrochloride) - Summary

DESYREL SUMMARY

DESYREL^®
(trazodone HCl)

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.

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NEWS HIGHLIGHTS

Published Studies Related to Desyrel (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.

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Clinical Trials Related to Desyrel (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.

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.

Xyrem for Treatment Refractory Insomnia Due to PTSD [Terminated]
Xyrem (sodium oxybate) is an agent with the propensity to improve slow wave sleep and sleep efficiency. It is FDA approved to treat cataplexy (drop attacks) associated with narcolepsy (sleep attacks). It has been shown to be a safe and effective agent here where deep, restorative slow wave sleep improves and next day cataplexy attacks tend not to occur.

Post Traumatic Stress Disorder (PTSD) is a psychiatric illness where a patient has witnessed or been involved in a traumatic event. After the event is over, nightmares, flashbacks, avoidance of people and places associated with trauma and hyperarousal occur which is incapacitating to the patient. One major part of PTSD hyperarousal is marked insomnia with multiple awakenings at night. This resultant poor sleep is compounded by use of SSRI serotonergic antianxiety agents (ie Zoloft(sertraline)) as first line therapy which tend to degrade slow wave, restorative sleep. Patients may respond to SSRI treatment but may fail to remit as they continue to have sleep problems. PTSD patients will often fail to respond to antihistamine (Desyrel (trazodone)) and benzodiazepine GABA hypnotic agents (Restoril(temazepam)) and continue with poor, interrupted sleep. It is possible that Xyrem’s ability to remarkably improve slow wave sleep may greatly help treatment refractory insomnia due to PTSD.

The author proposes an open-label study (no placebo) where 10 PTSD patients, who have failed usual PTSD treatments and have failed usual insomnia treatments in particular will be given Xyrem in addition to their current PTSD medication. The authors wish to determine if Xyrem is a safe treatment optionin this difficult-to-treat patient population.

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PATIENT REVIEWS / RATINGS / COMMENTS

Desyrel review by 30 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Moderate Side Effects
		Treatment Info
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
		Reported Results
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
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Severe Side Effects
		Treatment Info
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
		Reported Results
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
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		insomnia
Dosage & duration:		12.5 miligrams (dosage frequency: nightly) for the period of 6 weeks
Other conditions:		anxiety
Other drugs taken:		lorazepam, 5 mg, as needed, but I did not need it during the time I took the Trazedone
		Reported Results
Benefits:		I did sleep reliably and without waking up in the middle of the night
Side effects:		gradually got more and more sedated during the day. I functioned as though my IQ had dropped about 30 points. It kinda dumbed me down until I was screwing up at work--forgetting details, working slowly, not able to focus, etc. Also, I became very unassertive--not like me at all. When I realized what was happening, I went off it--and had a significant withdrawal reaction--shaking, extremely anxious, really weird. The withdrawal reaction subsided in a couple of days.
Comments:		I was prescribed this drug for insomnia. My MD told me that it had been used as an anti-depressant, but didn't work well for that, but was good for insomnia. She originally prescribed 25 mg, and suggested I work up from that if 25 was ineffective. I am very drug sensitive, so when 25 mg. really knocked me out and I could barely wake up the next day, I cut the pills in half, and that seemed to work--but I just gradually got the effects mentioned above. I realized later that I had taken the same drug, higher dose, under the name Desyrel when I was 43 for post partum depression. It didn't work, and it made my blood pressure go down--the number I remember is 77/44. Same reaction--very sedated, confused, etc. I would never have taken it, but it was not identified as Desyrel, even on the pharmacy information sheet, so I didn't realize what it was. The weird thing about this drug (for me) is that it makes me so confused, but subtly, that I can't think clearly enough to realize what is happening until it gets pretty bad. I know I am very sensitive, and this may be a completely idiosyncratic reaction, but I don't think so. When I talked to the pharmacist about it she said "Yeah, some people just can't take it." I know people who take 300 mg a night--and they are fine!.