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Name
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Generic Name
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Dosage Form
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Strength
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Description

SINEQUAN® (doxepin hydrochloride) is one of a class of psychotherapeutic agents known as
dibenzoxepin tricyclic compounds. The molecular formula of the compound is C19H21NO•HCl
having a molecular weight of 316. It is a white crystalline solid readily soluble in water, lower
alcohols and chloroform.
Inert ingredients for the capsule formulations are: hard gelatin capsules (which may contain Blue
1, Red 3, Red 40, Yellow 10, and other inert ingredients); magnesium stearate; sodium lauryl
sulfate; starch.
Inert ingredients for the oral concentrate formulation are: glycerin; methylparaben; peppermint
oil; propylparaben; water.

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INDICATIONS AND USAGE

Silenor is indicated for the treatment of insomnia characterized by difficulty with sleep
maintenance. The clinical trials performed in support of efficacy were up to 3 months in
duration.

DOSAGE AND ADMINISTRATION

The dose of Silenor should be individualized
Dosing in Adults
The recommended dose of Silenor for adults is 6 mg once daily. A 3 mg once daily dose
may be appropriate for some patients, if clinically indicated.
Dosing in the Elderly
The recommended starting dose of Silenor in elderly patients (= 65 years old) is 3 mg once
daily. The daily dose can be increased to 6 mg, if clinically indicated.
Administration
Silenor should be taken within 30 minutes of bedtime.
To minimize the potential for next day effects, Silenor should not be taken within 3 hours of a
meal.

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Contraindications

SINEQUAN is contraindicated in individuals who have shown hypersensitivity to the drug.
Possibility of cross sensitivity with other dibenzoxepines should be kept in mind.
SINEQUAN is contraindicated in patients with glaucoma or a tendency to urinary retention.
These disorders should be ruled out, particularly in older patients.

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WARNINGS AND PRECAUTIONS

Need to Evaluate for Comorbid Diagnoses
Because sleep disturbances may be the presenting manifestation of a physical and/or
psychiatric disorder, symptomatic treatment of insomnia should be initiated only after careful
evaluation of the patient. The failure of insomnia to remit after 7 to 10 days of treatment
may indicate the presence of a primary psychiatric and/or medical illness that should be
evaluated. Exacerbation of insomnia or the emergence of new cognitive or behavioral
abnormalities may be the consequence of an unrecognized psychiatric or physical disorder.
Such findings have emerged during the course of treatment with hypnotic drugs.
Abnormal Thinking and Behavioral Changes
Complex behaviors such as “sleep-driving” (i.e., driving while not fully awake after ingestion
of a hypnotic, with amnesia for the event) have been reported with hypnotics. These events
can occur in hypnotic-naive as well as in hypnotic-experienced persons. Although behaviors
such as “sleep-driving” may occur with hypnotics alone at therapeutic doses, the use of
alcohol and other CNS depressants with hypnotics appears to increase the risk of such
behaviors, as does the use of hypnotics at doses exceeding the maximum recommended dose.
Due to the risk to the patient and the community, discontinuation of Silenor should be
strongly considered for patients who report a “sleep-driving” episode. Other complex
behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been
reported in patients who are not fully awake after taking a hypnotic. As with “sleep-driving”,
patients usually do not remember these events. Amnesia, anxiety and other neuro-psychiatric
symptoms may occur unpredictably.
Suicide Risk and Worsening of Depression
In primarily depressed patients, worsening of depression, including suicidal thoughts and
actions (including completed suicides), has been reported in association with the use of
hypnotics.
Doxepin, the active ingredient in Silenor, is an antidepressant at doses 10- to 100-fold higher
than in Silenor. 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. Risk from the lower dose
of doxepin in Silenor can not be excluded.
It can rarely be determined with certainty whether a particular instance of the abnormal
behaviors listed above is drug induced, spontaneous in origin, or a result of an underlying
psychiatric or physical disorder. Nonetheless, the emergence of any new behavioral sign or
symptom of concern requires careful and immediate evaluation.
5.4. CNS Depressant Effects
After taking Silenor, patients should confine their activities to those necessary to prepare for
bed. Patients should avoid engaging in hazardous activities, such as operating a motor vehicle
or heavy machinery, at night after taking Silenor, and should be cautioned about potential
impairment in the performance of such activities that may occur the day following ingestion.
When taken with Silenor, the sedative effects of alcoholic beverages, sedating antihistamines,
and other CNS depressants may be potentiated [see Warnings and Precautions (5.2) and Drug
Interactions (7.3, 7.4)]. Patients should not consume alcohol with Silenor [see Warnings and
Precautions (5.2) and Drug Interactions (7.3]. Patients should be cautioned about potential
additive effects of Silenor used in combination with CNS depressants or sedating
antihistamines.

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