SINEQUAN IN-HOME WITHDRAWAL AND TAPERING PROGRAM

Sinequan is a psychotropic agent with antidepressant and anti-anxiety properties. A study published in JAMA internal Medicine in early 2015 found Sinequan increased the risk of developing dementia.

Because Sinequan also blocks the neurotransmitter Acetylcholine, it is not recommended for patients with a history of glaucoma, increased intraocular pressure or urinary retention. Like all Tricyclic antidepressants, when given in high doses, Sinequan can induce sinus tachycardia, changes in conduction time and arrhythmias of the heart.

All Antidepressants can cause withdrawal symptoms if abruptly stopped or tapered too rapidly and Sinequan is no different. It is recommended to taper slowly. 

Sinequan (Doxepin) is a psychotropic agent with antidepressant and anti-anxiety properties that was developed by Boehringer-Ingelheim, now part of the Roche group. Sinequan was tested from 1963-1968 in different German and Swiss psychiatric institutions and was approved in Germany initially, then in other countries.

Sinequan is a Tricyclic Antidepressant that exerts its action on Serotonin and Norepinephrine but also blocks Dopamine and the histamine receptors. Histamine is involved in the immune response and Dopamine is a critical neurotransmitter that plays important roles in both the brain and body.  Serotonin is primarily found in the gastrointestinal tract, central nervous system and in the blood platelets while Norepinephrine works as both a hormone and a neurotransmitter, stimulating the heart, sweat glands, blood vessels, large internal organs and the adrenals whereas Serotonin is involved in sleep, memory, regulation of the endocrine system, body temperature, mood and behavior and muscle movement. 

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SINEQUAN WITHDRAWAL SYMPTOMS MAY INCLUDE:

aggression, anxiety, balance issues , blurred vision, brain zaps, concentration impairment, constipation, crying spells, depersonalization, diarrhea, dizziness. electric shock sensations, fatigue, flatulence, flu-like symptoms, hallucinations, hostility, highly emotional, indigestion, irritability, impaired speech, insomnia, jumpy nerves, lack of coordination, lethargy, migraine headaches / increased headaches, nausea, nervousness, over-reacting to situations, paranoia, repetitive thoughts or songs, sensory & sleep disturbances, severe internal restlessness (akathisia), stomach cramps, tremors, tinnitus (ear ringing or buzzing), tingling sensations, troubling thoughts, visual hallucinations / illusions, vivid dreams, speech or visual changes, worsened depression 

SINEQUAN SIDE EFFECTS MAY INCLUDE: 

drowsiness, Blurred vision, breast development in males, bruises, buzzing or ringing in the ears, changes in sex drive, chills, confusion, constipation, diarrhea, difficulty urinating, disorientation, dizziness, dry mouth, enlarged breasts, fatigue, fluid retention, flushing, fragmented or incomplete movements, hair loss, hallucinations, headache, high fever, high or low blood sugar, inappropriate breast milk secretion, indigestion, inflammation of the mouth, itching and skin rash, lack of muscle control, loss of appetite, loss of coordination, low blood pressure, nausea, nervousness, numbness, poor bladder control, rapid heartbeat, red or brownish spots on the skin, seizures, sensitivity to light, severe muscle stiffness, sore throat, sweating, swelling of the testicles, taste disturbances, tingling sensation, tremors, vomiting, weakness, weight gain, yellow eyes and skin  

SINEQUAN ADVERSE REACTIONS MAY INCLUDE: per PDR  

Severe: seizures, agranulocytosis, hepatic failure, hyperkalemia, serotonin syndrome, AV block, bone fractures, suicidal ideation, ileus, heart failure, myocardial infarction, torsade de pointes, ventricular tachycardia, stroke, vasculitis, SIADH, bronchospasm, ocular hypertension 

Moderate: dysarthria, contact dermatitis, hypertension, dystonic reaction, pseudoparkinsonism, dyskinesia, chest pain (unspecified), edema, anemia, leukopenia, eosinophilia, thrombocytopenia, hyperthyroidism, goiter, hypothyroidism, diabetes mellitus, wheezing, dysuria, hepatitis, elevated hepatic enzymes, jaundice, hypermagnesemia, sinus tachycardia, ST-T wave changes, palpitations, hematoma, dyspnea, hyperbilirubinemia, hypokalemia, blepharospasm, constipation, orthostatic hypotension, impotence (erectile dysfunction), ejaculation dysfunction, urinary retention, blurred vision, withdrawal, memory impairment, migraine, peripheral neuropathy, ataxia, EEG changes, mania, depression, hallucinations, psychosis, hostility, delirium, akathisia, confusion, complex sleep-related behaviors, parotitis, glossitis, stomatitis, PR prolongation, QT prolongation, peripheral edema, galactorrhea, testicular swelling, erythema, hyperglycemia, hyponatremia / Delayed / Incidence not known hypoglycemia, cycloplegia, hyperthermia 

Mild: skin irritation, yawning, fatigue, nausea , appetite stimulation, hyperhidrosis, flushing, pharyngitis, syncope, insomnia, asthenia, nightmares, paresthesias, anorexia, dysgeusia, abdominal pain, gastroesophageal reflux, vomiting, diarrhea, alopecia, pruritus, pallor, rash, purpura, laryngitis, nasal congestion, sinusitis, infection, nocturia, arthralgia, myalgia, back pain, folliculitis, chills, cough, influenza, rhinorrhea, muscle cramps, diplopia, xerophthalmia, ocular pain, tinnitus, otalgia, lethargy, drowsiness, dizziness, xerostomia, dyspepsia, weight gain, headache, tremor, anxiety, irritability, agitation, restlessness, pyrosis (heartburn), tongue discoloration, libido decrease, breast enlargemen, dysmenorrhea, gynecomastia, petechiae, photosensitivity, urticaria, fever, increased urinary frequency, mydriasis

SINEQUAN BOXED WARNINGS: per PDR  

Children, suicidal ideation

The safety and efficacy of doxepin for the treatment of depression and/or anxiety in children under 12 years of age have not been established. The safety and efficacy of low-dose doxepin when used as a hypnotic agent, have not been established in children and adolescents under the age of 18 years old. Use of doxepin cream in pediatric patients is not recommended, due to the potential for systemic absorption and adverse effects; one case of toxicity has been reported in a young child. In October 2004, the FDA directed manufacturers of all antidepressants to include a boxed warning detailing the risk of suicide in pediatric patients. A causal role has been established for antidepressants in inducing suicidality in pediatric patients. The risk of suicidality for these drugs was identified in a pooled analysis of 24 placebo-controlled trials (n = 4,400) lasting up to 16 weeks in pediatric patients with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders. The analysis showed a greater risk of suicidality during the first few months of treatment in those receiving antidepressants (SSRIs and others). The average risk of such events on drug was 4% and 2% for placebo; however, no suicides occurred in these trials. Pooled analysis of short-term clinical trials during early phase treatment with SSRIs and other antidepressants in young adults (18 to 24 years) also showed an increased risk of suicidal thinking and behavior. The clinical need for an antidepressant in children or young adults for any use must be weighed against the risk of increased suicidality; patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior, particularly within the first few months of starting therapy or at the time of dose increase or decrease; such observation would generally include at least weekly face-to-face contact with patients during the first 4 weeks of treatment, then every other week visits for the next 4 weeks, then at 12 weeks, and as clinically indicated beyond 12 weeks; additional contact by telephone may be appropriate between visits. It is unknown if the suicidality risk in children or young adults extends to longer-term therapy (i.e., beyond several months). The possibility of a suicide attempt is inherent in patients with depressive symptoms, whether these occur in primary depression or in association with another primary psychiatric disorder. All patients with a history of suicidal ideation or behaviors and those with a prominence of suicidal ideation prior to treatment are considered at an increased risk for suicidal ideation or attempts, and should be closely monitored during treatment with doxepin. In primarily depressed patients, worsening of suicidal thoughts, including suicidal ideation, has occurred in association with hypnotic use; caution is also advisable when using low-dose doxepin as a hypnotic agent. The risk of suicidal ideation in children, adolescents, and young adults from the use of low-dose doxepin as a hypnotic agent is unknown but cannot be excluded. In patients who exhibit changes in symptoms, worsening of depression or emergent suicidality, a decision should be made to change or discontinue treatment. If discontinuing, the medication should be tapered as rapidly as possible, but with recognition that abrupt discontinuation can also cause adverse symptoms. Tricyclic antidepressants (TCAs) should be prescribed in the smallest quantity consistent with good patient management in order to reduce the risk of overdose.

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According to the FDA:

Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms.

Withdrawal Symptoms: The possibility of development of withdrawal symptoms upon abrupt cessation of treatment after prolonged SINEQUAN administration should be borne in mind. These are not indicative of addiction and gradual withdrawal of medication should not cause these symptoms. 

REFERENCES:

https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016798s054,017516s023lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/070791s027lbl.pdf

https://www.cigna.com/individuals-families/health-wellness/hw/medications/doxepin-d00217a1

https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020859s011lbl.pdf

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