Adult Dosing
Insomnia
Silenor
- 3-6 mg PO qhs
- Elderly patients: 3 mg PO qhs
- Max: 6 mg
- Note: Do not administer within 3 hrs of a meal
Depression/anxiety
doxepin capsules and concentrate (generic)
- Start 75 mg PO qd, increase or decrease the dose as per individual response; max: 150 mg/day
- Severely ill patients: Titrate the dose gradually to 300 mg/day if necessary
- Mild symptomatology or emotional symptoms accompanying organic disease: 25-50 mg/day
Note:
- The 150-mg capsule strength is intended for maintenance therapy only and is not recommended for initiation of treatment
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
Selinor
- Treatment of insomnia characterized by difficulty with sleep maintenance
doxepin capsules and concentrate (generic)
- Psychoneurotic patients with depression and/or anxiety
- Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol)
- Depression and/or anxiety associated with organic disease
- Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders
Black Box Warning for doxepin capsules and concentrate (generic)
- As per the short-term studies of major depressive disorder (MDD), antidepressants increase the risk compared to placebo of suicidal tendencies and behavioral changes in children, adolescents, and young adults. Balance this risk with clinical need when using antidepressants in children, adolescents, or young adults
- In short-term studies of antidepressants vs. placebo, suicidality risk was not increased in patients greater than 24 years and risk decreased in patients greater than 65 years
- Depression and other psychiatric disorders are themselves associated with increased risk of suicide
- Carefully weigh the risks and benefits before starting treatment; monitor patients closely for clinical worsening, suicidal tendencies and unusual changes in behavior. Advise families and caregivers of the need for close observation and communication with the physician
- Drug is not approved for use in pediatric patients
See Supplemental Patient Information
- Worsening of depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior may occur in pediatric and adult patients with major depressive disorder (MDD); risk may persist until significant remission occurs
- Antidepressants increase the risk of suicidal thinking and behavior in children, adolescents, and young adults with major depressive disorder and other psychiatric disorders [US Black Box Warning]
- Younger patients are more prone to suicidality; suicidality risk did not increase in patients >24 yrs of age, and risk decreased in patients >65 yrs of age [US Black Box Warning]
- Monitor and closely observe patients for clinical worsening, suicidality, or unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose modifications [US Black Box Warning]
- Anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have occurred in adults and pediatric patients
- Consider changing the therapeutic regimen or discontinuation of therapy on persistent worsening of depression, on experiencing emergent suicidality or abrupt onset of severe symptoms suggesting worsening of depression or suicidality or especially if they are not part of the patient's presenting symptoms
- If treatment is to be discontinued or dose reduction needed, gradually taper the dose to avoid adverse reactions
- Advise families and caregivers to monitor patient, for the emergence of agitation, irritability, unusual changes in behavior, emergence of suicidality, and report such symptoms immediately to health care providers
- Doxepin is not indicated for the treatment of bipolar depression. Therefore, prior to starting treatment in patients with depressive symptoms, determine if patient is at risk for bipolar disorder. Screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression
- The 150-mg capsule strength is intended for maintenance therapy only and is not recommended for initiation of treatment
- Treatment of insomnia should be initiated after careful evaluation of patient because sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder. Failure of insomnia to remit after 7-10 days of therapy may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated
- Complex behaviors such as "sleep-driving" may occur with hypnotics, use of alcohol and other CNS depressants with hypnotics increases the risk of such behavior
- Patients should avoid engaging in hazardous activities, such as operating a motor vehicle or heavy machinery, at night after taking doxepin because it impairs physical or mental performance
- It may be necessary to decrease the dose or add a major tranquilizer to the regimen if increased symptoms of psychosis or shift to manic symptomatology occurs
- Patients should not consume alcohol during therapy
Cautions: Use cautiously in
- Hepatic impairment
- Elderly patients
- Suicide risk
- Cardiovascular disorders
- Schizophrenia
- Thyroid disorder
- Alcohol use
- CNS depressant use
- Compromised respiratory function
- Patients <24 yrs
Supplemental Patient Information
- Advise patients to promptly report events such as “sleep-driving” and other complex behaviors immediately to their physicians
- Advise patients not to drink alcohol during therapy
- Advise patients to inform their physicians if their sleep problems get worse or do not improve within 7-10 days
Pregnancy Category:C
Breastfeeding: The active metabolite present in infant serum may cause excessive sedation; so an alternative drug may be preferred while nursing a newborn or preterm infant. If doxepin is required by the mother of an older infant, it is not a reason to discontinue breastfeeding, but the infant should be monitored for excessive sedation. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 4 March 2011). As per the manufacture's data, caution should be exercised when administered to nursing women.
Pricing data from www.DrugStore.com in U.S.A.
- Doxepin HCl 50 MG CAPS [Bottle] (MYLAN)
60 mg = $25.99
180 mg = $54.97 - Doxepin HCl 10 MG/ML CONC [Bottle] (TEVA PHARMACEUTICALS USA)
120 ml = $23.99
360 ml = $49.97 - Doxepin HCl 75 MG CAPS [Bottle] (MYLAN)
30 mg = $22.99
90 mg = $43.97 - Doxepin HCl 150 MG CAPS [Bottle] (PAR)
30 mg = $25.99
90 mg = $55.96
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
