FDA-filed SPL labeling · retrieved through openFDA

Doxepin (Insomnia)

A homeopathic sublingual spray used to temporarily ease occasional sleeplessness tied to anxiety, stress, or restlessness.

Brand names SilenorPrudoxinZonalon
Drug classes Non-standardized Food Allergenic Extract
OTC Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveOct 31, 2023
AvailabilityOTC
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 22, 2026
💊
HelloPharmacist Editorial Team Bottom Line
This is a homeopathic sublingual spray for occasional sleeplessness — its claims rest on traditional homeopathic practice, not FDA-reviewed clinical evidence. It's generally meant for short-term use only; if sleep problems persist beyond a week or worsen, see a doctor. As always, let your healthcare provider know about any new sleep concerns.

📖 Doxepin (Insomnia): Patient Information Guide

A plain-language walkthrough of Doxepin (Insomnia) — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

This product is used to temporarily relieve occasional difficulty sleeping related to:

  • Anxiety
  • Restlessness
  • Stress
  • Caffeine sensitivity

Important: These claims are based on traditional homeopathic practice — they are not supported by accepted medical evidence and have not been evaluated by the FDA.

💊How it's taken

This product comes as a sublingual spray — meaning you spray it directly under your tongue, where it absorbs quickly. Adults and children 12 and older use two sprays under the tongue at bedtime, and again if nighttime restlessness wakes them up.

  • Children under 12: check with a doctor first before using.
  • No food restrictions are listed, but follow the product label directions closely.
🤒Side effects — in detail

The label does not list specific side effects for this product. However, stop use and seek help if you believe you are having an allergic reaction, or if your symptoms worsen or don't improve within 7 days.

⚠️Warnings & precautions
  • Short-term use only: If sleep troubles last more than 7 days, get worse, or if new symptoms appear, stop use and talk to a doctor.
  • Allergic reactions: Do not use if you've ever reacted to this product or its ingredients.
  • Tamper seal: Do not use the product if the tamper-evident seal on the bottle is missing or broken.
  • Keep out of reach of children.
  • Overdose: If too much is taken, call Poison Control or get emergency help right away.
  • Pregnancy and breastfeeding: Ask a doctor before using.
🔀What it interacts with

The label does not list specific drug, food, or supplement interactions for this product. If you take other medications or have health conditions, check with your pharmacist or doctor before using.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Do not use if you have ever had an allergic reaction to this product or any of its ingredients.
  • If you are pregnant or breastfeeding, consult a doctor before use.
  • Children under 12 should only use this product under a doctor's guidance.
🚑If you take too much

The label does not describe specific overdose symptoms. If you think someone has taken too much, call a Poison Control Center right away or get emergency medical help immediately — don't wait for symptoms to appear.

📄 Written from Doxepin (Insomnia)’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

186

Supplements & herbs that interact with Doxepin (Insomnia)

186 supplements and herbal products have documented interactions with Doxepin (Insomnia) in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 15
  • Moderate · 145
  • Minor · 26
Every supplement checked against Doxepin (Insomnia) — ranked by severity The full interaction hub: 15 major · 145 moderate · 26 minor · every one linked to its full report. Check Doxepin (Insomnia) against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

1

Nutrient depletion considerations

Doxepin (Insomnia) has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

See the full Doxepin (Insomnia) nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Doxepin (Insomnia) — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is this product, and is it the same as prescription doxepin?
This is a homeopathic sublingual spray — it's very different from prescription doxepin, which is an FDA-approved medication used at low doses for insomnia. This spray's claims are based on traditional homeopathic practice and have not been evaluated or approved by the FDA for effectiveness. If you're looking for a clinically proven sleep treatment, it's worth having that conversation with your doctor.
How do I use it correctly?
Spray two sprays directly under your tongue at bedtime. If you wake up during the night feeling restless, you can use it again then too. Hold it under the tongue briefly so it can absorb. If your child is under 12, check with a doctor before giving them any.
How long can I use this product?
This is really meant for occasional, short-term use. If your sleep problems are still there after 7 days, get worse, or if you notice any new symptoms, stop using it and see a doctor. Lasting sleep trouble sometimes has an underlying cause that needs attention.
Is it safe to use if I'm pregnant or breastfeeding?
The label says to ask your doctor before using this product if you're pregnant or breastfeeding. It's always the right call to check in with your provider before adding anything new — even a homeopathic product — when you're pregnant or nursing.
What should I do if I accidentally take too much?
Call Poison Control right away or get emergency medical help immediately — don't wait to see how you feel. Keep this product, like all medications and health products, stored where children can't reach it.
How do I know the product is safe to use when I open it?
Before you use it, check the tamper-evident seal around the neck of the bottle. If that seal is missing or broken, don't use the product — set it aside and contact the place where you bought it. This seal is there to make sure the product hasn't been tampered with.
Is Doxepin (Insomnia) available over the counter?
Yes — Doxepin (Insomnia) is available over the counter (without a prescription) in at least some forms, according to its FDA labeling. Follow the package directions and ask your pharmacist if you're unsure which product is right for you.

💬 Answers drafted from Doxepin (Insomnia)’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

📈 How widely Doxepin (Insomnia) is used

A general measure of how commonly Doxepin (Insomnia) is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Doxepin (Insomnia) is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

628,470
Medicaid prescriptions filled (Q1–Q4 2025)
$30.9M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Doxepin (Insomnia) prescribed? Of the 1,596 medications we measure, Doxepin (Insomnia) ranks #233 by Medicaid prescriptions — more than 85% of them.

Where Doxepin (Insomnia) ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Doxepin (Insomnia) product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 10 mg oral capsule is the most-dispensed Doxepin (Insomnia) product — about 30% of these Medicaid prescriptions.

doxepin 10 MG Oral Capsule Most dispensed

189,409 Medicaid prescriptions (Q1–Q4 2025) 30% of Doxepin (Insomnia) prescriptions shown $2.2M gross reimbursement (before rebates) ≈ $12 per prescription (gross)

Summed across the 16 of 95 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1000048

doxepin 25 MG Oral Capsule

127,554 Medicaid prescriptions (Q1–Q4 2025) 20% of Doxepin (Insomnia) prescriptions shown $1.7M gross reimbursement (before rebates) ≈ $14 per prescription (gross)

Summed across the 14 of 113 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1000070

doxepin 50 MG Oral Capsule

108,904 Medicaid prescriptions (Q1–Q4 2025) 17% of Doxepin (Insomnia) prescriptions shown $1.6M gross reimbursement (before rebates) ≈ $14 per prescription (gross)

Summed across the 14 of 82 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1000076

doxepin 100 MG Oral Capsule

67,651 Medicaid prescriptions (Q1–Q4 2025) 11% of Doxepin (Insomnia) prescriptions shown $1.3M gross reimbursement (before rebates) ≈ $20 per prescription (gross)

Summed across the 13 of 52 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1000058

doxepin hydrochloride 50 MG/ML Topical Cream

36,950 Medicaid prescriptions (Q1–Q4 2025) 6% of Doxepin (Insomnia) prescriptions shown $19.6M gross reimbursement (before rebates) ≈ $530 per prescription (gross)

Summed across the 6 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1000091

doxepin 150 MG Oral Capsule

29,510 Medicaid prescriptions (Q1–Q4 2025) 5% of Doxepin (Insomnia) prescriptions shown $823,737 gross reimbursement (before rebates) ≈ $28 per prescription (gross)

Summed across the 5 of 15 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1000064

doxepin 75 MG Oral Capsule

27,128 Medicaid prescriptions (Q1–Q4 2025) 4% of Doxepin (Insomnia) prescriptions shown $500,793 gross reimbursement (before rebates) ≈ $18 per prescription (gross)

Summed across the 12 of 45 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1000097

doxepin 10 MG/ML Oral Solution

14,180 Medicaid prescriptions (Q1–Q4 2025) 2% of Doxepin (Insomnia) prescriptions shown $526,403 gross reimbursement (before rebates) ≈ $37 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1000054

doxepin 3 MG Oral Tablet

13,865 Medicaid prescriptions (Q1–Q4 2025) 2% of Doxepin (Insomnia) prescriptions shown $1.3M gross reimbursement (before rebates) ≈ $97 per prescription (gross)

Summed across the 8 of 43 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 966787

doxepin 6 MG Oral Tablet

13,319 Medicaid prescriptions (Q1–Q4 2025) 2% of Doxepin (Insomnia) prescriptions shown $1.2M gross reimbursement (before rebates) ≈ $94 per prescription (gross)

Summed across the 8 of 48 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 966793

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Doxepin (Insomnia), and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 97 of 501 listed Doxepin (Insomnia) NDCs with Medicaid activity.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Doxepin (Insomnia) RxCUI 3638 4 dose forms · 10 strengths
  1. Dose form (SCDF) Oral Capsule RxCUI 371962 No current FDA listing
    Clinical drug / strength (SCD) 10 MG RxCUI 1000048 25 MG RxCUI 1000070 50 MG RxCUI 1000076 75 MG RxCUI 1000097 100 MG RxCUI 1000058 150 MG RxCUI 1000064
  2. Dose form (SCDF) Oral Solution RxCUI 379135 No current FDA listing
    Clinical drug / strength (SCD) 10 MG/ML RxCUI 1000054
  3. Dose form (SCDF) Oral Tablet RxCUI 375040 No current FDA listing
    Clinical drug / strength (SCD) 3 MG RxCUI 966787 6 MG RxCUI 966793
  4. Dose form (SCDF) Topical Cream RxCUI 377691 No current FDA listing
    Clinical drug / strength (SCD) hydrochloride 50 MG/ML RxCUI 1000091

Look up RxCUI 3638 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Silenor Prudoxin Zonalon

RxNorm drug class

Doxepin (Insomnia) belongs to the Tricyclic Antidepressant class.

Pharmacologic class Tricyclic Antidepressant
Drug family (ATC) Other antipruritics, Non-selective monoamine reuptake inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Oct 31, 2023
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Doxepin (Insomnia).
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Doxepin (Insomnia) after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
Linked representative label
Liddell Laboratories, Inc.
Linked label effective
Oct 31, 2023
Composite sections available
6
Linked SPL Set ID
18c15f17-1a16-4595-9d23-20353363cd72
Linked SPL Document ID
b5a38025-d7f8-4589-9c07-553bdca09e1f
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Liddell Laboratories, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.