Doxepin is a brand of Doxepin.
Doxepin tablets are indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in suppo.
From the official label (Nov 2025). Your prescription and pharmacist come first.
What the official label says. If a doctor prescribed it, follow the prescription. Your pack's leaflet comes first if it is different.
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 )
Doxepin Tablets are available containing 3.39 mg or 6.78 mg of doxepin hydrochloride, USP equivalent to 3 mg or 6 mg of doxepin, respectively. Doxepin tablets are not scored. The 3 mg tablets are light blue, round, biconvex, beveled edge tablet debossed with 161 on one side of the tablet and plain on the other side. …
A total of 362 subjects who were ≥ 65 years and 86 subjects who were ≥ 75 years received doxepin tablets 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. …
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 hepatic cytochrome P450 isozymes CYP2C19 and CYP2D6, and to a lesser extent, by CYP1A2 and CYP2C9. Inhibitors of these isozymes may increase the exposure of doxepin. …
Need to Evaluate for comorbid diagnoses: Reevaluate if insomnia persists after 7 to 10 days of use. ( 5.1 ) Abnormal thinking, behavioral changes, complex behaviors: May include “Sleep-driving” and hallucinations. Immediately evaluate any new onset behavioral changes. ( 5.2 ) Depression: Worsening of depression or suicidal thinking may occur. Prescribe the least amount feasible to avoid intentional overdose. ( 5.3 ) CNS-depressant effects: Use can impair alertness and motor coordination. Avoid engaging in hazardous activities such as operating a motor vehicle or heavy machinery after taking drug. ( 5.4 ) Do not use with alcohol. …
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 patients treated with placebo, were somnolence/sedation, nausea, and upper respiratory tract infection. …
8.1 Pregnancy Risk Summary Available data from published epidemiologic studies and postmarketing reports have not established an increased risk of major birth defects or miscarriage (see Data) . There are risks of poor neonatal adaptation with exposure to tricyclic antidepressants (TCAs), including doxepin, during pregnancy (see Clinical Considerations). …
Doxepin is routinely administered for indications other than insomnia at doses 10- to 50-fold higher than the highest recommended dose of doxepin tablets. The signs and symptoms associated with doxepin use at doses several-fold higher than the maximum recommended dose (Excessive dose) of doxepin tablets for the treatment of insomnia are described [ see Overdosage ( 10.1 ) ], as are signs and symptoms associated with higher multiples of the maximum recommended dose (Critical overdose) [ see Overdosage ( 10.2 ) ]. …
9.1 Controlled Substance Doxepin is not a controlled substance. 9.2 Abuse Doxepin is not associated with abuse potential in animals or in humans. Physicians should carefully evaluate patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse of doxepin (e.g., incrementation of dose, drug-seeking behavior). …
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. …
Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.
Prices in other countries are not what you will pay where you live; they show how prices compare.
Price of Doxepin in: United Kingdom
Products with Doxepin as the active ingredient. Names differ between countries.
Other countries: check your pack's registration number and we point you to your regulator.
A recall usually affects certain batches only. Compare the lot number on your pack.
Type the registration number on the pack, or scan it with your camera.
Doxepin contains Doxepin. Other brands with the same active ingredient work the same way; the dose and strength on your pack are what matter.
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 ) (From the official U.S. FDA label.)
Follow your prescription or the leaflet in your pack. The official label says: The dose of doxepin tablets should be individualized. Initial dose: 6 mg, once daily for adults ( 2.1 ) and 3 mg, once daily for the elderly. ( 2.1 , 2.2 ) Take within 30 minutes of bedtime. Total daily dose should not exceed 6 mg. ( 2.3 ) Should not be taken within 3 hours of a meal. ( 2.3 , 12.3 ) 2.1 Dosing in Adults The recommended dose of doxepin tablets for adults is 6 mg…
Abnormal thinking, behavioral changes, complex behaviors: May include “Sleep-driving” and hallucinations.
Usually yes. Doxepin is a prescription medicine in most countries. Rules differ by country.
Doxepin is sold under names such as Prudoxin, Silenor, Zonalon. Brand names differ between countries.
The official label lists: 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 advers… Tell your doctor about any side effect that bothers you or does not go away.
The safety and effectiveness of doxepin tablets in pediatric patients have not been evaluated. Always use the dose for the child's age or weight on the pack or prescription.
8.1 Pregnancy Risk Summary Available data from published epidemiologic studies and postmarketing reports have not established an increased risk of major birth defects or miscarriage (see Data) . There are risks of poor neonatal adaptation with exposure to tricyclic antidepressants (TCAs), including doxepin, during pregnancy (see Clinical Considerations). … Ask your doctor or midwife first.
The official label says: 4 ) Do not use with alcohol.
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 hypogly… Use the free interaction checker before combining medicines.
Doxepin is routinely administered for indications other than insomnia at doses 10- to 50-fold higher than the highest recommended dose of doxepin tablets. The signs and symptoms associated with doxepin use at doses several-fold higher than the maximum recommended dose (Excessive dose) of doxepin tab… Get medical help right away.
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. …
Scan the registration number on your pack with PillVera (NAFDAC number in Nigeria, NDC in the United States, DIN in Canada), check the expiry date and buy only from licensed pharmacies.
This page shows what official sources say, in plain words. It is not medical advice: your prescription and your doctor or pharmacist come first. Brand names, strengths and rules differ between countries.