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Silenor (Doxepin HCL)

Indications

• Silenor is primarily prescribed to treat insomnia, helping you fall asleep and stay asleep throughout the night.
• Although its main use is for insomnia, doxepin can also be used to treat depression and anxiety in some cases.

Ingredients

• Active Ingredient: Doxepin Hydrochloride
• Inactive Ingredients: Microcrystalline cellulose, colloidal silicon dioxide, FD&C Blue No. 1, and FD&C Yellow No. 10.

Dosage and Administration

• Take Silenor exactly as prescribed by your healthcare provider.
• Administer the tablet within 30 minutes before bedtime to ensure effective sleep induction.
• Take the tablet whole with a glass of water.
• Do not take Silenor within 3 hours of a meal, as it may affect its effectiveness.
• Do not crush or chew the tablet.
• Do not skip doses.

Mechanism of Action

Doxepin works by affecting the balance of certain natural chemicals (neurotransmitters) in the brain, particularly by enhancing the effect of histamine which helps to promote sleep. By modulating these chemicals, Silenor helps improve the duration and quality of sleep.

Contraindications

• Do not take it if you are allergic to Doxepin or any other ingredients in Silenor.
• Avoid using the tablet if you have untreated narrow-angle glaucoma, as it can increase eye pressure.
• Do not take it if you have a history of severe urinary retention.
• Avoid Silenor if you are currently taking or have recently taken monoamine oxidase inhibitors (MAOIs).

Side Effects

Common Side Effects

• Drowsiness
• Dry mouth
• Dizziness
• Nausea
• Blurred vision
• Constipation

Serious Side Effects

• Severe dizziness or fainting
• Mood changes such as agitation or confusion
• Unusual thoughts or behavior
• Signs of an allergic reaction like rash, itching, or swelling

Precautions

• Be aware of any changes in mood, behavior, or thoughts of suicide, especially when starting Silenor or changing dosage.
• Avoid alcohol as it can increase certain side effects, including drowsiness and dizziness.
• Do not drive or operate heavy machinery until you know how Silenor affects you.
• Consult your doctor if you are pregnant, planning to become pregnant, or breastfeeding.

Storage Instructions

• Keep Silenor at a controlled room temperature, between 20°C to 25°C (68°F to 77°F).
• Store in a dry place away from light and moisture.
• Keep out of reach of children.
• Do not store it in the bathroom as the humidity from showers can affect the medication.

References

https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022036s006lbl.pdf