Trazodone (generic only) was approved by the FDA in 1981 for treatment of major depression. It is a selective serotonin reuptake inhibitor (SSRI). We have designated trazodone as Do Not Use because it has more harmful adverse effects (see Adverse Effects of Antidepressants tablesee Adverse Effects of Antidepressants table in Depression: When are Drugs Called For And Which Ones Should You Use?) than other newer SSRIs. For patients who need an antidepressant drug, we recommend trying one of the...
Trazodone (generic only) was approved by the FDA in 1981 for treatment of major depression. It is a selective serotonin reuptake inhibitor (SSRI). We have designated trazodone as Do Not Use because it has more harmful adverse effects (see Adverse Effects of Antidepressants tablesee Adverse Effects of Antidepressants table in Depression: When are Drugs Called For And Which Ones Should You Use?) than other newer SSRIs. For patients who need an antidepressant drug, we recommend trying one of the newer SSRIs (for example, fluoxetine [PROZAC, SARAFEM, SELFEMRA]) first, as these are the safest antidepressants. If symptoms do not improve sufficiently with use of an SSRI and remain severe, further treatment with other antidepressants is warranted.
|Patients over 60 generally need to take one-third to one-half the dose used by younger adults. If the initial dose is not enough and needs to be increased, this should be done very slowly.
The length of time it takes an antidepressant to work can overlap with the time of spontaneous recovery, especially if the depression is situational (if it is caused by a death or other external circumstances). Most people lift themselves out of depression with friends, spiritual resources, or activities such as exercise, work, reading, play, art, and travel. If depression is not overcome by these measures, seek help from mental health professionals, such as therapists or psychiatrists. Antidepressant drugs should be reserved for major depression in which the patient does not respond to psychotherapy alone.
Trazodone can cause painful, prolonged penile erections (priapism) in men. If you suffer this reaction, stop taking the drug and notify your doctor.
Do not use trazodone if you are recovering from a heart attack.
A major meta-analysis commissioned by the U.S. Department of Health and Human Services failed to find any significant differences in effectiveness between older antidepressants (such as tricyclic antidepressants) and newer antidepressants (such as selective serotonin reuptake inhibitors, commonly known as SSRIs).
In terms of adverse drug reactions, there was no significant difference between the new and old antidepressants in overall discontinuation rates of use of these drugs by patients. (Drug discontinuation rates can be used to compare adverse reactions between drugs.)
Regulatory actions surrounding trazodone
2004: In October 2004, the FDA issued a public health advisory requiring manufacturers to add a black box warning (see above) to its professional product labeling (package insert) of all antidepressants. A black box warning is the strongest type of warning that the FDA can require. The FDA also requires that a Patient Medication Guide be given to patients receiving this drug advising them of the risk and precautions that can be taken.
2007: The FDA announced in May 2007 that it will require new warnings concerning the increased risk of suicidal thoughts and behavior in young adults ages 18 to 24 during the first one to two months of treatment with antidepressants. The agency wants the new warnings to be black box warnings printed on the professional product labels for all antidepressants sold in the US. The warning is an amendment to an existing black box warning for children and adolescents.
The FDA-approved professional product labeling for antidepressant drugs sold in the United States carries the following statement:
Suicide: The possibility of a suicide attempt is inherent in major depressive disorder and may persist until significant remission occurs. Close supervision of high-risk patients should accompany initial drug therapy. Prescriptions for Drug X should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.