Status checked on October 6, 2026 dailymed.nlm.nih.gov
Zepbound (tirzepatide): FDA-approved uses for weight and sleep apnea, label population, general dosing, trials, side effects, boxed warning and dated prices.
Fact-checked against FDA labels and official sources; not yet reviewed by a licensed clinician. This page is education, not medical advice. Talk to your doctor before starting, stopping or changing any treatment.
Key facts
- Active ingredient
- Tirzepatide: how the dual GIP/GLP-1 drug works (Zepbound, Mounjaro)
- Class
- GIP/GLP-1 dual agonist
- Route
- Injection
- How often
- Weekly
- Manufacturer
- Eli Lilly
- Approved for weight
- Yes
- First approved
- 2023
- Generic available
- No
- Controlled substance
- No
- Official label
- Prescribing information
Key takeaways
- Zepbound is FDA approved for chronic weight management in adults and, since December 20, 2024, for moderate to severe obstructive sleep apnea in adults with obesity.[1]
- In SURMOUNT-1, adults lost 15.0% to 20.9% of their body weight on average over 72 weeks depending on dose, compared with 3.1% on placebo.[5]
- Nausea, diarrhea, vomiting and constipation are the most common side effects; Zepbound has a boxed warning about thyroid C-cell tumors seen in rats.[1]
- The label advises a non-oral or added barrier contraceptive for 4 weeks after starting and after each dose increase.[1]
- Self-pay KwikPen prices were $299 to $449 a month by dose (higher doses with on-time refills), checked on 2026-10-06.[9]
In short: Zepbound is Eli Lilly’s brand of tirzepatide for weight. It is FDA approved, with a reduced-calorie diet and more physical activity, to reduce excess body weight and keep it off long term in adults with obesity, or overweight plus at least one weight-related condition, and to treat moderate to severe obstructive sleep apnea in adults with obesity. It is a once-weekly injection, sold as single-dose pens, vials and a multi-dose KwikPen (status checked on the FDA label on 2026-10-06).
Here is what the official prescribing information and the main trials say about Zepbound, written for people who want to understand it before talking with a clinician. It is general information, not personal medical advice.
What Zepbound is
The active ingredient is tirzepatide, a “dual agonist” that acts on two gut-hormone receptors, GIP and GLP-1. Our tirzepatide page explains how that works. In everyday terms, it reduces appetite and helps people feel full on less food. Tirzepatide is also sold as Mounjaro, which is approved for type 2 diabetes rather than for weight management; Zepbound is the tirzepatide brand with the weight and sleep apnea indications. The label says Zepbound should not be used with other tirzepatide products or with any GLP-1 receptor agonist.
FDA status and approved uses
Drugs@FDA lists the original Zepbound approval on November 8, 2023 for chronic weight management. On December 20, 2024 the FDA approved it as the first medication for moderate to severe obstructive sleep apnea (OSA) in adults with obesity, again together with diet and activity changes. Zepbound is approved for adults only; it is not approved for children or teens.
Who it is labeled for
In the label’s words, Zepbound is for adults with obesity, adults with overweight in the presence of at least one weight-related comorbid condition, and adults with obesity who have moderate to severe OSA. When the FDA approved it for weight in 2023, it described the population as adults with a BMI of 30 or more, or 27 or more with a condition such as high blood pressure, type 2 diabetes or high cholesterol. Only a clinician who knows your history can say whether it fits you; our BMI calculator gives a starting reference point.
How it is taken, in general
Zepbound is injected under the skin once a week. The label describes a low starting dose for four weeks, then increases in steps every four weeks until a maintenance dose is reached; the maintenance range for sleep apnea is narrower than for weight. The multi-dose KwikPen holds four weekly doses, and the label warns that pens must never be shared between people, even with a new needle. Your prescriber decides the dose and pace.
One practical point from the label: tirzepatide can make birth-control pills less reliable for a while. People using oral hormonal contraception are advised to switch to a non-oral method, or add a barrier method, for four weeks after starting and for four weeks after each dose increase.
What the studies showed
In SURMOUNT-1 (New England Journal of Medicine, 2022), 2,539 adults without diabetes took weekly tirzepatide at 5, 10 or 15 mg, or placebo, for 72 weeks. Average weight change was -15.0%, -19.5% and -20.9% at the three doses, compared with -3.1% on placebo. In SURMOUNT-4, people who had lost an average of 20.9% during a 36-week lead-in and then switched to placebo regained 14.0% over the next year, while those who continued lost a further 5.5%.
For sleep apnea, the two SURMOUNT-OSA trials (2024) measured the apnea-hypopnea index (AHI), the number of breathing pauses per hour of sleep. After 52 weeks, AHI fell by about 25 to 29 events per hour with tirzepatide, compared with about 5 with placebo. In SURMOUNT-5, a head-to-head trial against semaglutide, average weight change at 72 weeks was -20.2% with tirzepatide and -13.7% with semaglutide; see Wegovy vs Zepbound for what that comparison can and cannot tell you.
Side effects
In the label’s pooled weight trials, nausea affected 25% to 29% of people on Zepbound (8% on placebo), diarrhea 19% to 23% (8%), vomiting 8% to 13% (2%) and constipation 11% to 17% (5%). Abdominal pain, indigestion, injection-site reactions, fatigue, allergic reactions, burping, hair loss and reflux are also listed. Most digestive effects appear while the dose is being increased.
The warnings include severe digestive reactions, kidney injury from dehydration, gallbladder disease, acute pancreatitis, serious allergic reactions, low blood sugar when combined with insulin or sulfonylureas, diabetic eye complications, and the risk of inhaling stomach contents during anesthesia or deep sedation. Read GLP-1 side effects for how these are recognized, and Zepbound side effects for the brand detail.
Boxed warning and who should not use it
Like the other drugs in this group, Zepbound carries a boxed warning: tirzepatide caused thyroid C-cell tumors in rats, and it is unknown whether it causes such tumors, including medullary thyroid carcinoma (MTC), in humans. It must not be used by people with a personal or family history of MTC or with MEN 2, or by anyone with a known serious allergy to tirzepatide.
Pregnancy and breastfeeding
The label states that weight loss offers no benefit during pregnancy and may cause fetal harm, and that Zepbound should be stopped when a pregnancy is recognized. Talk with your clinician before starting if you are planning a pregnancy or breastfeeding.
Pens, vials and the KwikPen: cost and savings
Prices checked on 2026-10-06 on Lilly’s Zepbound site. Self-pay for the single-patient-use KwikPen is $299 a month for the 2.5 mg starting dose and $399 for 5 mg. The higher doses (7.5 mg to 15 mg) are $449 a month as long as each refill is bought within 45 days of the previous one; otherwise the regular price applies ($499 for 7.5 mg and $699 for 10 mg to 15 mg). Self-pay vials are also offered, starting at $299 a month. With commercial insurance that covers Zepbound, the savings card can bring the cost to as little as $25 for a 1- to 3-month fill (the card expires December 31, 2026). Medicare’s temporary GLP-1 Bridge (July 2026 to December 2027) includes the Zepbound KwikPen for weight management with a $50 copay for people who meet its criteria; sleep apnea goes through regular Part D plans. Our Zepbound cost page keeps the full, dated table.
Stopping, compounded products and alternatives
Because weight tends to return after stopping, plan any change with your prescriber; our guide to life after a GLP-1 covers the evidence. Compounded “tirzepatide” is not Zepbound and is not FDA approved: the FDA resolved the tirzepatide shortage in December 2024 and warns about unapproved versions sold online (see compounded GLP-1s). Other approved options include Wegovy and the daily pill Foundayo; the medications hub lists every option with its status badge, and the protein calculator helps you plan meals that protect muscle.
FDA status and approved uses
| Indication | Labeled population | For weight | Approved | Source |
|---|---|---|---|---|
| Reduce excess body weight and maintain weight reduction long term (with reduced-calorie diet and increased physical activity) | Adults with obesity, or adults with overweight and at least one weight-related comorbid condition | Yes | November 8, 2023 | Source |
| Moderate to severe obstructive sleep apnea (with reduced-calorie diet and increased physical activity) | Adults with obesity | No | December 20, 2024 | Source |
From the FDA label. Who a medicine is labeled for is not the same as whether it fits you; only a clinician can decide that.
How it is taken (in general)
Once weekly under the skin of the stomach, thigh or upper arm, with or without meals. The label describes a starting dose for 4 weeks, then increases every 4 weeks to a maintenance dose. Never share pens. Follow your prescriber.
This is what the label describes in general, never a personal dose or schedule. Follow your prescriber.
What studies showed
| Trial | Population | Duration | Outcome as reported |
|---|---|---|---|
| SURMOUNT-1 NCT04184622 | 2,539 adults with BMI 30+ (or 27+ with a weight-related complication), no diabetes | 72 weeks | Mean weight change -15.0% (5 mg), -19.5% (10 mg), -20.9% (15 mg) vs -3.1% placebo.[5] |
| SURMOUNT-OSA (trials 1 and 2) NCT05412004 | Adults with obesity and moderate to severe OSA | 52 weeks | AHI change -25.3 and -29.3 events per hour with tirzepatide vs -5.3 and -5.5 with placebo.[6] |
| SURMOUNT-4 NCT04660643 | 670 adults who completed a 36-week lead-in (mean loss 20.9%) | 52 weeks after randomization | Continued tirzepatide -5.5% vs +14.0% after switching to placebo.[7] |
| SURMOUNT-5 (vs semaglutide) NCT05822830 | 751 adults with obesity, no type 2 diabetes | 72 weeks | Weight change -20.2% with tirzepatide vs -13.7% with semaglutide (open label).[8] |
Average results from trials; individual results vary. Results from different trials cannot be compared directly.
Side effects
| Common side effect | How often (label) |
|---|---|
| Nausea | 25% to 29% (5 to 15 mg) vs 8% placebo |
| Diarrhea | 19% to 23% vs 8% placebo |
| Vomiting | 8% to 13% vs 2% placebo |
| Constipation | 11% to 17% vs 5% placebo |
| Abdominal pain | 9% to 10% vs 5% placebo |
| Dyspepsia (indigestion) | 9% to 10% vs 4% placebo |
| Injection-site reactions | 6% to 8% vs 2% placebo |
| Fatigue | 5% to 7% vs 3% placebo |
Serious risks
- Thyroid C-cell tumors (boxed warning, seen in rats)
- Severe gastrointestinal adverse reactions
- Acute kidney injury from fluid loss
- Acute gallbladder disease
- Acute pancreatitis
- Hypersensitivity reactions
- Hypoglycemia, especially with insulin or a sulfonylurea
- Diabetic retinopathy complications in people with type 2 diabetes
- Pulmonary aspiration during general anesthesia or deep sedation
- Never share a KwikPen between patients
More detail: Zepbound Side Effects: common, serious and how they compare
Warnings and who should not use it
Boxed warning
Risk of thyroid C-cell tumors: in rats, tirzepatide causes thyroid C-cell tumors. It is unknown whether Zepbound causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans. Zepbound is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Who should not use it (per the label)
- Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
- Known serious hypersensitivity to tirzepatide or any of the excipients
Interactions, pregnancy and breastfeeding
| Drug or class | What the label says |
|---|---|
| Oral hormonal contraceptives | Possible reduced effect: the label advises switching to a non-oral method or adding a barrier method for 4 weeks after starting and after each dose increase. |
| Other tirzepatide products or GLP-1 receptor agonists | Coadministration should be avoided. |
| Insulin or insulin secretagogues | Higher risk of low blood sugar; doses of those medicines may need adjusting. |
Pregnancy and breastfeeding
The label states that weight loss offers no benefit to a pregnant patient and may cause fetal harm; discontinue Zepbound when pregnancy is recognized. Animal studies showed reduced fetal growth and abnormalities.
Cost, insurance and savings
| Price | Amount | Basis | Checked on |
|---|---|---|---|
| Self-pay / cash | 299 USD | per month, 2.5 mg KwikPen or vials (LillyDirect and other pharmacies) | October 6, 2026 |
| Self-pay / cash | 399 USD | per month, 5 mg KwikPen | October 6, 2026 |
| Self-pay / cash | 449 USD | per month, 7.5 mg to 15 mg KwikPen, refill within 45 days (regular $499 for 7.5 mg, $699 for 10 to 15 mg) | October 6, 2026 |
| With savings program | 25 USD | per 1- to 3-month fill with commercial coverage (card expires 2026-12-31) | October 6, 2026 |
Prices change often and depend on pharmacy, plan and location. Insurance can change what you pay. Every price shows the date we checked it.
Savings programs
- Zepbound Savings Card: Commercial insurance; government beneficiaries excluded; expires 2026-12-31 (checked October 6, 2026)
- Zepbound Self-Pay Journey (KwikPen and vials): Valid prescription; refill within 45 days for the 7.5 mg to 15 mg offer (checked October 6, 2026)
- Medicare GLP-1 Bridge: Eligible Part D enrollees, Zepbound KwikPen for weight, July 1, 2026 to December 31, 2027; $50 copay (checked October 6, 2026)
Full price guide: Zepbound Cost: pens, vials and savings (prices checked monthly)
Stopping and keeping results
Trials show that weight often returns after these medicines are stopped. Plan any change with your prescriber. Stopping a GLP-1: what trials show and how people keep results
Compounded and counterfeit versions
Compounded semaglutide and tirzepatide are not FDA approved: the FDA does not review them for safety, quality or effectiveness. Counterfeit pens and "research peptides" sold online have caused harm. Buy only from a licensed pharmacy with a prescription.
Same active ingredient
FDA approved for another usePrescriptionInjectionMounjaro (tirzepatide): approved uses and how it differs from ZepboundTirzepatide: how the dual GIP/GLP-1 drug works (Zepbound, Mounjaro) · Injection · Weekly
FDA approved for another usePrescriptionInjectionMounjaro Side Effects: what the label lists, by dose, and when to get helpTirzepatide: how the dual GIP/GLP-1 drug works (Zepbound, Mounjaro)
FDA approved for weight managementPrescriptionInjectionZepbound Side Effects: common, serious and how they compareTirzepatide: how the dual GIP/GLP-1 drug works (Zepbound, Mounjaro)Same class
Compare with
Non-drug approaches
FDA approved for weight managementPrescriptionInjectionWegovy (semaglutide): uses, side effects, cost and FDA statusSemaglutide: one ingredient, several brands · Injection · Weekly
FDA approved for weight managementPrescriptionPillFoundayo (orforglipron): status, uses and what is confirmedOrforglipron: the small-molecule GLP-1 pill and its current status · Pill (tablet) · Daily
Strength Training for Weight Loss: keep muscle while losing fatModerate · Low impact
FDA approved for weight managementPrescriptionInjectionSaxenda (liraglutide 3 mg): uses, side effects and costLiraglutide: the daily GLP-1 (Saxenda, Victoza) and generics · Injection · DailyCost and coverage
Research mentioning it
What’s Coming in 2027: Weight-Loss Treatments Awaiting FDA DecisionsWeight-loss treatments awaiting FDA decisions in 2027: CagriSema, retatrutide, survodutide, MariTide and more, with filing dates,…
A History of Weight-Loss Drugs: From Thyroid Pills and Fen-Phen to GLP-1sA history of weight-loss drugs from FDA records: dinitrophenol, amphetamines, fen-phen, sibutramine and Belviq withdrawals, orlistat,…
What’s New in Weight Loss in 2026: New Methods, What’s Proven and What’s HypeWhat is new in weight loss in 2026: GLP-1 pills, Wegovy HD, Foundayo, lower prices and…Related guides
GLP-1 Medications: how they work and which are approved for weightGLP-1 medications explained: what GLP-1 is, how the drugs work, which brands are FDA approved for…
GLP-1 Side Effects: common, serious and how they are managedGLP-1 side effects from the FDA labels: common digestive effects by brand, serious risks, the thyroid…
Compounded Semaglutide and Tirzepatide: what FDA says and the risksCompounded semaglutide and tirzepatide explained: not FDA approved, the dated shortage history, FDA safety reports, counterfeit…
Stopping a GLP-1: regain, what trials show and keeping resultsWhat happens when you stop a GLP-1: STEP 1 extension, STEP 4, SURMOUNT-4 and BMJ meta-analysis…Tools for this topic
Questions to ask your doctor or pharmacist
- Given my health history, what are the likely benefits and risks of Zepbound for me?
- Is there anything in my personal or family history, such as thyroid cancer or MEN 2, that rules it out?
- Should I use the KwikPen, vials or single-dose pens, and how does my insurance treat each?
- How should we handle birth control and any diabetes medicines while the dose is increasing?
- What is our plan for protein, strength training and the long term if I stop?
Frequently asked questions
Is Zepbound the same as Mounjaro?
Both contain tirzepatide, but Zepbound is approved for chronic weight management and sleep apnea in adults with obesity, while Mounjaro is approved for type 2 diabetes. They are separate products with separate labels.
How much weight do people lose on Zepbound?
In SURMOUNT-1, average weight loss after 72 weeks was 15.0% to 20.9% of starting weight depending on the dose, versus 3.1% with placebo. Results vary from person to person.
What is the difference between the Zepbound pen, vial and KwikPen?
All contain tirzepatide for weekly injection. Single-dose pens and vials hold one dose each; the multi-dose KwikPen holds four weekly doses. Self-pay pricing on the Lilly site applies to the KwikPen and vials, not the single-dose pen.
Does Zepbound affect birth control pills?
It can. The label advises people on oral hormonal contraceptives to switch to a non-oral method or add a barrier method for 4 weeks after starting and after each dose increase.
Is Zepbound approved for teenagers?
No. As of 2026-10-06, the Zepbound label covers adults only.
Official sources
References
- ZEPBOUND (tirzepatide) injection: prescribing information. Eli Lilly and Company, via DailyMed, 2026. (accessed October 7, 2026) Drug label
- Drugs@FDA: Zepbound, NDA 217806. U.S. Food and Drug Administration. (accessed October 7, 2026) Government page
- FDA Approves New Medication for Chronic Weight Management. U.S. Food and Drug Administration, 2023. (accessed October 6, 2026) Government page
- FDA Approves First Medication for Obstructive Sleep Apnea. U.S. Food and Drug Administration, 2024. (accessed October 7, 2026) Government page
- Jastreboff AM, Aronne LJ, Ahmad NN, et al.. Tirzepatide Once Weekly for the Treatment of Obesity (SURMOUNT-1). New England Journal of Medicine, 2022. doi:10.1056/NEJMoa2206038 · PMID 35658024 · NCT04184622 (accessed October 7, 2026) Randomized trial
- Malhotra A, Grunstein RR, Fietze I, et al.. Tirzepatide for the Treatment of Obstructive Sleep Apnea and Obesity (SURMOUNT-OSA). New England Journal of Medicine, 2024. doi:10.1056/NEJMoa2404881 · PMID 38912654 · NCT05412004 (accessed October 6, 2026) Randomized trial
- Aronne LJ, Sattar N, Horn DB, et al.. Continued Treatment With Tirzepatide for Maintenance of Weight Reduction in Adults With Obesity: The SURMOUNT-4 Randomized Clinical Trial. JAMA, 2024. doi:10.1001/jama.2023.24945 · PMID 38078870 · NCT04660643 (accessed October 7, 2026) Randomized trial
- Aronne LJ, Horn DB, le Roux CW, et al.. Tirzepatide as Compared with Semaglutide for the Treatment of Obesity (SURMOUNT-5). New England Journal of Medicine, 2025. doi:10.1056/NEJMoa2416394 · PMID 40353578 · NCT05822830 (accessed October 6, 2026) Randomized trial
- Zepbound coverage and savings. Eli Lilly and Company. (accessed October 6, 2026) Other
- Medicare GLP-1 Bridge: information for providers. Centers for Medicare and Medicaid Services. (accessed October 7, 2026) Government page
- FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize (content current as of 2026-04-01). U.S. Food and Drug Administration. (accessed October 6, 2026) Government page
Facts checked on October 6, 2026
Educational information, not medical advice. Talk with a qualified healthcare professional about your own situation. In an emergency call 911.