What is Doxepin used for?

1 INDICATIONS AND USAGE Doxepin tablets are 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. Doxepin tablets are indicated for the treatment of insomnia characterized by difficulties with sleep maintenance. ( 1 , 14 )

How does Doxepin work?

11 DESCRIPTION Doxepin Tablets are available in 3 mg and 6 mg strengths for oral administration.

What is the active ingredient in Doxepin?

Doxepinum (Doxepini hydrochloridum)

What pharmaceutical form is Doxepin available in?

Doxepin: Kapsułki twarde 10 mg (doustna)

Is Doxepin OTC or prescription only?

Doxepin requires a doctor's prescription.

What are the side effects of Doxepin?

6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of labeling: • Abnormal thinking and behavioral changes [ see Warnings and Precautions ( 5.2 ) ]. • Suicide risk and worsening of depression [ see Warnings and Precautions ( 5.3) ]. • CNS Depressant effects [ see Warnings and Precautions ( 5.4 ) ]. The most common treatment-emergent adverse reactions, reported in ≥ 2% of patients treated with doxepin tablets, and more commonly than in pa

Who should NOT take Doxepin?

4 CONTRAINDICATIONS Hypersensitivity to doxepin hydrochloride, inactive ingredients, or other dibenzoxepines. ( 4.1 ) Co-administration with Monoamine Oxidase Inhibitors (MAOIs): Do not administer if patient is taking MAOIs or has used MAOIs within the past two weeks. ( 4.2 ) Untreated narrow angle glaucoma or severe urinary retention. ( 4.3 ) 4.1 Hypersensitivity Doxepin tablets are contraindicated in individuals who have shown hypersensitivity to doxepin HCl, any of its inactive ingredients, o

Does Doxepin interact with other medications?

7 DRUG INTERACTIONS MAO inhibitors: Doxepin tablets should not be administered in patients on MAOIs within the past two weeks. ( 4.2 ) Cimetidine: Increases exposure to doxepin. ( 7.2 ) Alcohol: Sedative effects may be increased with doxepin. ( 7.3 , 5.4 ) CNS Depressants and Sedating Antihistamines: Sedative effects may be increased with doxepin. ( 7.4 , 5.4 ) Tolazamide: A case of severe hypoglycemia has been reported. ( 7.5 ) 7.1 Cytochrome P450 Isozymes Doxepin is primarily metabolized by he

Can Doxepin be used during pregnancy?

8 USE IN SPECIFIC POPULATIONS Pregnancy: Third trimester use may increase the risk for symptoms of poor adaptation (respiratory distress, temperature instability, feeding difficulties, hypotonia, tremor, irritability) in the neonate. ( 8.1 ) Lactation: Breastfeeding not recommended. ( 8.2 ) Pediatric Use: Safety and effectiveness have not been evaluated. ( 8.4 ) Geriatric Use: The recommended starting dose is 3 mg. Monitor prior to considering dose escalation. ( 2.2 , 8.5 ) Use in Patients with

What precautions should be taken with Doxepin?

• Caution should be exercised in patients with history of enlarged prostate, diabetes, seizures, an overactive thyroid gland, liver, kidney or heart disease, any allergy, who are taking other medications, elderly, during pregnancy and breastfeeding. • It may cause drowsiness, do not drive a car or operate machinery while taking this medication. • Avoid alcohol consumption.

Who manufactures Doxepin?

Teva Pharmaceuticals Polska Sp. z o.o. (Polska)

What ATC class does Doxepin belong to?

Doxepin: ATC N06AA12. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

Doxepin

10 mg, Kapsułki twarde

INN: Doxepinum

Data updated: 2026-04-13

Available in:

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Form

Kapsułki twarde

Dosage

10 mg

Route

doustna

Storage

16.2 Storage and Handling Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

Used to treat:

Depression F32Insomnia / Sleep Disorders G47.0

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