Silenor Information
Silenor () . 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 []
Silenor () . Dosage And Administration
The dose of Silenor () should be individualized.
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 []
The total Silenor () dose should not exceed 6 mg per day.
Silenor () . Dosage Forms And Strengths
Silenor () is an immediate-release, oval-shaped, tablet for oral administration available in strengths of 3 mg and 6 mg. The tablets are blue (3 mg) or green (6 mg) and are debossed with 3 or 6, respectively, on one side and SP on the other. Silenor () tablets are scored.
Silenor () . Warnings And Precautions
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.
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 [s]. Patients should not consume alcohol with Silenor () [s]. Patients should be cautioned about potential additive effects of Silenor () used in combination with CNS depressants or sedating antihistamines [s].
Silenor () . Adverse Reactions
The following serious adverse reactions are discussed in greater detail in other sections of labeling:
The pre-marketing development program for Silenor () included doxepin HCl exposures in 1017 subjects (580 insomnia patients and 437 healthy subjects) from 12 studies conducted in the United States. 863 of these subjects (580 insomnia patients and 283 healthy subjects) participated in six randomized, placebo-controlled efficacy studies with Silenor () doses of 1 mg, 3 mg, and 6 mg for up to 3-months in duration.
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. However, data from the Silenor () studies provide the physician with a basis for estimating the relative contributions of drug and non-drug factors to adverse reaction incidence rates in the populations studied.
Silenor () was administered to 1017 subjects in clinical trials in the United States. Treatment-emergent adverse reactions recorded by clinical investigators were standardized using a modified MedDRA dictionary of preferred terms. The following is a list of MedDRA terms that reflect treatment-emergent adverse reactions reported by subjects treated with Silenor () .
Adverse reactions are further categorized by body system and listed in order of decreasing frequency according to the following definitions: adverse reactions are those that occurred on one or more occasions in at least 1/100 subjects; adverse reactions are those that occurred in fewer than 1/100 subjects and more than 1/1000 subjects. adverse reactions are those that occurred in fewer than 1/1000 subjects. Adverse reactions that are listed in Table 1 are not included in the following listing of frequent, infrequent, and rare AEs.
Blood and Lymphatic System Disorders:
Cardiac Disorders:
Ear and Labyrinth Disorders:
Eye Disorders:
Gastrointestinal Disorders:
General Disorders and Administration Site Conditions
Hepatobiliary Disorders:
Immune System Disorders:
Infections and Infestations
Injury, Poisoning and Procedural Complications:
Investigations:
Metabolism and Nutrition Disorders:
Neoplasms Benign, Malignant and Unspecified (Including Cysts and Polyps)
Nervous System Disorders
Psychiatric Disorders
Reproductive System and Breast Disorders
Renal and Urinary Disorders
Respiratory, Thoracic and Mediastinal Disorders
Skin and Subcutaneous Tissue Disorders
Surgical and Medical Procedures
Vascular Disorders
In addition, the reactions below have been reported for other tricyclics and may be idiosyncratic (not related to dose).
Allergic:
Hematologic:
Silenor () . Use In Specific Populations
A total of 362 subjects who were ≥ 65 years and 86 subjects who were ≥ 75 years received Silenor () in controlled clinical studies. No overall differences in safety or effectiveness were observed between these subjects and younger adult subjects. Greater sensitivity of some older individuals cannot be ruled out.
Sleep-promoting drugs may cause confusion and over-sedation in the elderly. A starting dose of 3 mg is recommended in this population and evaluation prior to considering dose escalation is recommended
Silenor () . Overdosage
Doxepin is routinely administered for indications other than insomnia at doses 10- to 50-fold higher than the highest recommended dose of Silenor () .
The signs and symptoms associated with doxepin use at doses several-fold higher than the maximum recommended dose (Excessive dose) of Silenor () for the treatment of insomnia are described , as are signs and symptoms associated with higher multiples of the maximum recommended dose (Critical overdose) .
Silenor () . Description
Silenor () (doxepin) is available in 3 mg and 6 mg strength tablets for oral administration. Each tablet contains 3.39 mg or 6.78 mg doxepin hydrochloride, equivalent to 3 mg and 6mg of doxepin, respectively.
Chemically, doxepin hydrochloride is an (E) and (Z) geometric, isomeric mixture of 1 propanamine, 3-dibenz[]oxepin-11(6)ylidene--dimethyl-hydrochloride. It has the following structure:
Doxepin hydrochloride is a white crystalline powder, with a slight amine-like odor, that is readily soluble in water. It has a molecular weight of 315.84 and molecular formula of C H NO•HCl.
Each Silenor () tablet includes the following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate. The 3 mg tablet also contains FD&C Blue No.1. The 6 mg tablet also contains D&C Yellow No. 10 and FD&C Blue No. 1.
Silenor () . How Supplied/storage And Handling
Silenor () 3 mg tablets are oval shaped, blue, identified with debossed markings of "3" on one side and "SP" on the other, and are supplied as:
Silenor () 6 mg tablets are oval shaped, green, identified with debossed markings of "6" on one side and "SP" on the other, and are supplied as:
Silenor () . Patient Counseling Information
Prescribers or other healthcare professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with hypnotics, should counsel them in appropriate use, and should instruct them to read the accompanying Medication Guide [].
There have been reports of people getting out of bed after taking a hypnotic and driving their cars while not fully awake, often with no memory of the event. If a patient experiences such an episode, it should be reported to his or her doctor immediately, since "sleep-driving" can be dangerous. This behavior is more likely to occur when a hypnotic is taken with alcohol or other central nervous system depressants []. 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.
In addition, patients should be advised to report all concomitant medications to the prescriber. Patients should be instructed to report events such as "sleep-driving" and other complex behaviors immediately to the prescriber.
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