1st opioid overdose reversal drug approved over-the-counter: What to know (2023)

Amid the worsening U.S. overdose crisis, experts say a simple drug — naloxone — is a key tool in preventing more deaths. But not enough people know about it, have access to it or actually carry it with them. Now, for the first time, Narcan, a brand name of naloxone, will be available over the counter without a prescription.

In an effort to make the drug available to more people, the Food and Drug Administration on Wednesday, March 29, approved Narcan, a nasal spray version of naloxone, to be sold over the counter directly to consumers. The FDA first approved Narcan in 2015, but it’s only been available to people with a prescription or through certain community harm-reduction programs.

“Today’s approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of locations where it’s available and help reduce opioid overdose deaths throughout the country,” FDA Commissioner Dr. Robert M. Califf, said in a statement.

It’s not clear exactly when Narcan will hit shelves because the availability and price are ultimately determined by the manufacturer, according to the FDA. “We encourage the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price,” Califf said in the statement.

NBC News reported that Narcan likely won’t be available until late summer 2023 at the earliest, per Narcan’s manufacturer, Emergent BioSolutions. Once this happens, it could be sold at grocery stores, convenience stores and vending machines.

“Harm reduction advocates have pushed to make this happen for decades. Thanks for all their efforts to prioritize getting naloxone into the hands of people who use drugs and their loved ones,” Dr. Kimberly Sue, medical director for the National Harm Reduction Coalition and associate professor of medicine at Yale School of Medicine, wrote on Twitter after the announcement.

“Naloxone is a miracle drug,” Sue tells TODAY.com. “It’s literally a Lazarus drug that prevents people from dying of an opioid overdose.”

And in the midst of the overdose crisis, which claimed nearly 108,000 lives in just 2021 (the most recent year for which data are available), getting naloxone to those who need it is vitally important, experts say.

Learn more about what Narcan is, how to get it and how it can save lives.

(Video) FDA approves first over-the-counter drug for opioid overdose reversal

How does Narcan work?

Naloxone is what experts call an opioid antagonist, Dr. Sarah Wakeman, medical director for the Massachusetts General Hospital Substance Use Disorder Initiative, tells TODAY.com. Narcan is not the only branded naloxone product; a high-dose nasal spray called Kloxxado works similarly, according to the FDA.

That means it “binds to the opioid receptors in the brain — the same receptors that opioid drugs or medications like oxycodone or heroin or fentanyl bind to — and then blocks those receptors,” Wakeman explains. In the event of an opioid overdose, naloxone “can actually kick off the opioid from the receptor, reverse the acute effects of an opioid overdose and save someone’s life.”

A standard dose of naloxone is effective against even fentanyl, Wakeman says. If they’ve taken an opioid and something else, or if they took something like cocaine that was tainted with illicit fentanyl, naloxone will still work against the opioid in their system.

“And naloxone won’t be harmful to someone who doesn’t have an opioid in their body,” Wakeman says. “So if there’s a possibility that you think someone is having an overdose ... then it is always a good idea to give naloxone.”

When should Narcan or naloxone be given?

Before using Narcan or naloxone, check to see if someone has the telltale signs of an overdose, Dr. Ayana Jordan, an addiction expert and associate professor of psychiatry at NYU Grossman School of Medicine, tells TODAY.com. She points to the Center for Disease Control and Prevention‘s tips to learn about the signs of an overdose.

According to the CDC, someone having an overdose may have:

  • Loss of consciousness.

  • Weak, slow or no breathing.

  • Small or constricted pupils.

    (Video) First over-the-counter opioid overdose treatment gets FDA approval

  • Choking or gurgling sounds.

  • Limp body.

  • Clammy or cold skin.

Blue or discolored skin, especially around the lips. (However, Jordan notes that this may not apply to people with darker skin.)

In general, someone who is in the midst of an overdose will “have slowed and very shallow breathing to the point that, ultimately, they’ll stop breathing,” Wakeman says. “So they may look blue or cold and not be responsive.”

Giving someone Narcan or naloxone

Once you’ve identified that someone might be having an overdose, you should call 911, the CDC says. Even if you’re able to reverse the overdose, they will likely still need emergency services. (Some states, but not all, have Good Samaritan laws, which protect people calling for medical help from some drug-related charges, Sue explains.)

From there, the right way to use naloxone depends on the specific formulation you’re using. For most people, that will likely be the nasal spray called Narcan, Wakeman says. In the hospital, naloxone may be given through an IV or as an injection into the muscle, she added.

After administering naloxone, the person should wake up within seconds to minutes, Wakeman says.

And you should always start with as low a dose as possible. If someone is a regular opioid user and you give them a massive dose of naloxone all at once, “they’re going to immediately go into withdrawal,” Wakeman explains. While that isn’t necessarily harmful, it is pretty unpleasant and uncomfortable.

(Video) FDA approves Narcan as first over-the-counter opioid overdose-reversal drug

After giving someone naloxone, you should stay with them if you can until emergency medical help arrives. “Naloxone works very quickly, but it also wears off very quickly,” Wakeman says. In fact, the effects of naloxone can wear off within 30 minutes. And if someone still has the other opioid in their system, they may fall back into an overdose after the naloxone has worn off.

Where to get Narcan or naloxone

If you use drugs, your doctor may give you a naloxone prescription as a regular part of their practice. “I make sure that everyone that sees me gets prescribed naloxone and that they understand how to use it,” Jordan says.

Despite the FDA’s new announcement, it’s not clear when exactly consumers will start to be able to get Narcan over the counter. It could be as soon as the end of summer 2023, NBC News reported. After the manufacturer is able to make it widely available over the counter, you could see it in grocery and convenience stores.

Until then, depending on your state, you may be able to get naloxone at a local pharmacy without a prescription through the use of a standing order, Wakeman notes. (Standing orders allow pharmacies to give out prescription medications, like the annual flu vaccine, without requiring each individual person to have their own prescription.)

Another option is to connect with local harm reduction groups in your area, which frequently hand out naloxone kits, Wakeman says. These community-based organizations may also offer in-person or virtual training on how to use naloxone. Jordan notes that her research group also does large virtual naloxone training sessions for people who participate in their studies looking at drug use.

If you live in a state without a standing order and want to get naloxone to use on someone else, you can likely get a third-party prescription through a doctor, Sue says. She recommended looking at the local health department’s website for more information about where to get naloxone in your area.

It’s most important for people who use drugs to have access to naloxone. But if you know someone who uses drugs, you should consider carrying naloxone, too, the experts say. “Carrying naloxone is no different than carrying an epi-pen,” Jordan says.

And even though there are several ways to get naloxone now, there are still barriers to actually accessing and using it, Sue explains. She recalls a story of pharmacy staff being simply unaware of the standing order for naloxone, for instance, and notes that harm reduction groups are experiencing an ongoing naloxone shortage.

Additionally, naloxone is something that, by definition, people can’t use on themselves in the event of an overdose, Sue says. (If you are going to use drugs by yourself, Sue recommends calling the Never Use Alone hotline so there is someone who can notify emergency services if you lose consciousness.)

(Video) Interview: FDA approves Narcan as first over-the-counter opioid overdose-reversal drug

Narcan is a crucial tool in reducing overdose deaths, experts say

“Really, no one should die from an opioid overdose,” Wakeman says. “Not only do we know how to prevent overdoses and how to treat people who have an opioid use disorder, but we also have this life-saving, immediately-acting medication that will quickly reverse the effects of an opioid overdose.”

The challenge for experts now is to make naloxone more accessible to those who need it. “There’s no moral or medical reason to keep this life-saving medication behind the counter,” Dr. Bobby Mukkamala, chair of the American Medicine Association’s Substance Use and Pain Care Task Force, tells TODAY.com.

Last year, AMA urged the Biden administration to remove naloxone’s prescription status, which would make it available over the counter. The FDA's Narcan announcement will make that a reality.

“It’s not the kind of thing that needs to be protected or that people need to be protected from,” Mukkamala says. “This saves their lives, and the fewer barriers we have to getting this into their hands and into their medicine cabinets, the better.”

For Jordan, the importance of naloxone comes down to one simple truth: “I can’t help people who are dead,” she says.

A version of this story was originally published Aug. 1, 2022.

This article was originally published on TODAY.com

Originally published


Is Narcan approved for over the counter? ›

Narcan , the naloxone nasal spray used to reverse opioid overdose, was approved Wednesday for over-the-counter sale by the FDA . It's a major victory for harm reduction advocates and public health professionals—and a much needed step toward preventing thousands of overdose deaths each year.

What is the FDA approved overdose reversal medication? ›

The US Food and Drug Administration (FDA) has approved the sale of naloxone, a nasal spray known as Narcan, without a prescription as an emergency treatment to reverse drug overdoses.

What is the first line medication in the treatment of an opioid overdose? ›

Naloxone should be administered to anyone who presents with signs of opioid overdose or when opioid overdose is suspected. Naloxone is approved by the Food and Drug Administration (FDA) and has been used for decades by EMS personnel to reverse opioid overdose and resuscitate individuals who have overdosed on opioids.

What antidotes are used to reverse opioid toxicity? ›

What is naloxone? Naloxone is a life-saving medication that can reverse an overdose from opioids—including heroin, fentanyl, and prescription opioid medications—when given in time. Naloxone is easy to use and small to carry.

When will naloxone OTC be available? ›

Washington, D.C.—Pharmacists can expect OTC Narcan nasal spray to be available by late summer, according to the manufacturer. Emergent BioSolutions, Inc.

Does Walgreens sell Narcan over the counter? ›

Walgreens will sell new overdose antidote over the counter

The FDA approved Narcan, a four-milligram naloxone hydrochloride nasal spray, to be sold over the counter.

What is the over the counter opioid reversal drug? ›

Today, the Food and Drug Administration (FDA) approved over-the-counter Narcan, an easy-to-use naloxone nasal spray that rapidly reverses the effects of opioid overdose.

What opioid overdose antidote did the FDA open to make available over the counter? ›

A drug used to reverse opioid overdoses could soon be sold over the counter. A committee of advisers to the Food and Drug Administration this week voted unanimously in favor of making Narcan, a nasal-spray version of the generic drug naloxone, available without a prescription.

What is the new opioid reversal agent? ›

Naloxone can reverse the life-threatening respiratory depression associated with opioid overdose. A variety of naloxone products (nasal spray, injection, auto-injection) are available to respond to an overdose. Most health insurance plans, including Medicaid and Medicare plans, will cover at least one form of naloxone.

What is a first line drug to treat? ›

a drug that is the first choice for treating a particular condition because it is considered a very effective treatment for that condition with the least likelihood of causing side effects. A first-line medication may be a class of drugs (e.g., SSRIs for depression) as well as a single drug.

What comes first Narcan or CPR? ›

If the patient is not breathing begin CPR. CPR takes priority over the administration of Naloxone! safest & quickest device to administer Narcan. Naloxone usually takes effect within 2-3 minutes.

What is the first line treatment for substance use? ›

Research shows that when treating addictions to opioids (prescription pain relievers or drugs like heroin or fentanyl), medication should be the first line of treatment, usually combined with some form of behavioral therapy or counseling. Medications are also available to help treat addiction to alcohol and nicotine.

What is rapid opioid reversal by naloxone? ›

Naloxone is a medication approved by the Food and Drug Administration (FDA) designed to rapidly reverse opioid overdose. It is an opioid antagonist—meaning that it binds to opioid receptors and can reverse and block the effects of other opioids, such as heroin, morphine, and oxycodone.

What is the universal antidote naloxone? ›

Naloxone has been the only antidote to opioids for over 50 years, and the drug has been readily available as a parenteral formula. The belief is that naloxone acts as a pure mu-opiate receptor competitive antagonist.

What drugs are similar to Narcan? ›

Naloxone (Narcan, Evzio) and naltrexone (ReVia, Depade) are two drugs used to help people with opioid addictions. They're both in a class of drugs called opioid antagonists, but they do different things.

How much does a naloxone kit cost? ›

Cost of naloxone: Depending on the specific form of naloxone used by the department, the cost of a single naloxone rescue kit ranges from approximately $22-$60 for intranasal kits.

How do you administer naloxone? ›

Gently insert the tip of the nozzle into one nostril, until your fingers on either side of the nozzle are against the bottom of the person's nose. Press the plunger firmly to give the dose of Narcan® Nasal Spray. Remove the Narcan® Nasal Spray from the nostril after giving the dose.

Is naloxone the same as Narcan? ›

When naloxone was first approved to reverse opioid overdoses, its brand name was “Narcan.” There are now other formulations and brand names for naloxone, but many people continue to call all of these products “Narcan.” However, the proper generic name is “naloxone.”

What states is Narcan over the counter? ›

Narcan (naloxone) is a potentially lifesaving nasal spray medication that can revive someone who has overdosed on opioids. Narcan can be expensive, but states have been working to make it cheaper and easier to find. Three states — Ohio, Delaware, and Iowa — provide free Narcan.

Does Walmart give Narcan? ›

Naloxone is a medication that can stop an overdose and prevent death. Walmart and Sam's Club are committed to having Naloxone behind the pharmacy counters of our stores and clubs and dispensing naloxone upon request, where allowed by state law.

Are there Narcan vending machines? ›

A health care facility that treats addiction and behavioral issues recently installed Narcan vending machines throughout several areas of Putnam County. Narcan is a nasal spray that is used to reverse the effects of a drug overdose.

Are there OTC opioids? ›

Examples of OTC opioid-containing products are cough medicines and pain medicines that contain a low dose of codeine along with acetaminophen, acetylsalicylic acid ( ASA ), or caffeine.

What drug neutralizes opioids? ›

Naloxone (also known as Narcan) is a safe medication that can reverse an overdose that is caused by an opioid drug such as prescription pain medication or heroin. It works by neutralizing the opioids in your system and helping you breathe again.

Can you get Lofexidine over the counter? ›

Lofexidine may also be used as part of a complete program, together with medical supervision and counseling, to treat opioid addiction. This medicine is available only with your doctor's prescription.

What are the 3 FDA approved medications for opioid use disorder? ›

There are three drugs approved by the FDA for the treatment of opioid dependence: buprenorphine, methadone, and naltrexone. All three of these treatments have been demonstrated to be safe and effective in combination with counseling and psychosocial support.

What was the first opioid antagonist? ›

Naloxone is the first opioid antagonist to be developed that is devoid of agonist activity. Naloxone is a synthetic N-allyl derivative of oxymorphone.

What is the reversal agent for OxyContin? ›

Naloxone only works on overdoses caused by opioids. This family of drugs includes prescription painkillers like OxyContin, fentanyl, methadone, and Vicodin, as well as street drugs like heroin.

Which of the following medications has an effective reversal agent? ›

Reversal: Naloxone (Narcan) We'll start with one you've likely already heard of, thanks to the opioid epidemic in the United States. Naloxone reverses the effects of opioids by kicking the opioid off the receptor sites and binding them up for a period of time.

What is the new opioid agonist? ›

Today, the U.S. Food and Drug Administration approved Olinvyk (oliceridine), an opioid agonist for the management of moderate to severe acute pain in adults, where the pain is severe enough to require an intravenous opioid and for whom alternative treatments are inadequate.

What drugs are reversal agents? ›

Reversal or “antidote” drugs, such as flumazenil and naloxone, are often used in unintentional overdose situations involving significant benzodiazepine- and/or opioid-induced respiratory depression.

Which drug is used as a first line drug in the absence? ›

Ethosuximide has been used since 1958 as a first-choice drug for the treatment of absence seizures without generalized tonic-clonic seizures.

What are the four first line drugs? ›

The initial phase of treatment is crucial for preventing the emergence of drug resistance and determining the ultimate outcome of the regimen. Four drugs— INH, RIF, PZA, and EMB— should be included in the initial treatment regimen until the results of drug-susceptibility tests are available.

What is 1st 2nd line treatment? ›

Second-line treatment is treatment for a disease or condition after the initial treatment (first-line treatment) has failed, stopped working, or has side effects that aren't tolerated. It's important to understand "lines of treatment" and how they differ from first line treatment and can play a role in clinical trials.

Do you give rescue breaths or naloxone first? ›

If victim is breathing and has a pulse, after you call 911 and give naloxone, turn them on their side to the recovery position. STAY WITH THE VICTIM! If victim is not breathing, provide 2 rescue breaths, then 1 every 5-6 seconds.

What comes first naloxone or oxygen? ›

Ideally, individuals who are experiencing opioid overdose should be ventilated with 100% oxygen before naloxone is administered so as to reduce the risk of acute lung injury [5,7].

When should naloxone or Narcan be used? ›

315) You should give naloxone to anyone who has taken drugs and may be overdosing. Someone who is overdosing may stop breathing or their breathing may be slow and labored. Act fast! An overdose is life threatening.

What is 1st line vs 2nd line drugs? ›

Your first-line treatment may not work, may start but then stop working, or may cause serious side effects. Your doctor may then suggest a second-line treatment, also called second-line therapy. It is a different treatment that is likely to be effective.

What is 1st line drug vs 2nd line drug? ›

The first-line therapeutic drugs are the most effective and least toxic for use in the treatment of TB, while the second-line therapeutic drugs are less effective, more expensive and have higher toxicities.

What is the order of treatment? ›

A treatment order, which is made by a judge, requires an unfit accused to be made fit to stand trial through psychiatric treatment. It is a unique circumstance where the accused does not have a choice in receiving treatment.

What can rapid reversal with Narcan lead to? ›

Precautions and Adverse Reactions

Care is required in patients who are dependent on opiates because naloxone can precipitate withdrawal syndrome. A rapid reversal of opioids can induce catecholamine release and cause excitation, ventricular arrhythmias, hypotension, pulmonary edema, convulsions, and death.

Is Narcan over the counter? ›

The nasal spray form of Narcan is the only form of naloxone that's been FDA-approved for over-the-counter use because it's been proven to be highly effective when an opioid overdose has occurred.

How many doses of Narcan can you give? ›

There's no limit or maximum number of Narcan doses that can be given to someone. Narcan begins working within 2 to 3 minutes after it's given. If the person who receives Narcan doesn't start to breathe normally within that period of time, you should give them another dose of the drug.

What are the 3 components of universal antidote? ›

u·ni·ver·sal an·ti·dote. a dated mixture of two parts activated charcoal, one part tannic acid, and one part magnesium oxide intended to be administered to patients who consumed poison.

What are the three forms of naloxone? ›

There are three types of naloxone available: injectable; auto- injectable; and prepackaged nasal spray.

What is generic substitute for Narcan? ›

Narcan is available as the generic drug naloxone.

Does Narcan work on anything other than opioids? ›

Will naloxone (Narcan) work if the person overdosed on something other than an opioid? No. Naloxone (Narcan) will only work to reverse the effects of opioids.

What can you not take with naloxone? ›

Using naloxone will stop the effectiveness of these drugs for 30 to 90 minutes.
This might precipitate withdrawal symptoms like nausea, vomiting, or muscle pain, if you take any of the following:
  • Morphine.
  • Methadone.
  • Buprenorphine (Suboxone, Subutex)
  • Oxycodone.
  • Hydrocodone.
  • Codeine.
  • Imodium.

Can anyone use a Narcan kit? ›

If someone has overdosed, a naloxone kit can be used to save them. You can get a kit from a specially trained pharmacist without a prescription, but it may not be covered by your medical insurance unless your doctor writes an order. Naloxone is also known by the brand name Narcan.

How much is a can of Narcan? ›

Narcan Prices, Coupons and Patient Assistance Programs. Narcan (naloxone) is commonly used for Opioid Overdose. The cost for Narcan nasal spray (4 mg/0.1 mL) is around $141 for a supply of 2 spray, depending on the pharmacy you visit.

Is Narcan cost effective? ›

Naloxone is a highly cost-effective way to prevent overdose deaths,” said Coffin.

Where is the best place to use Narcan? ›

Injecting into the muscle of the upper thigh or upper arm (see below) with a syringe is also a very common way to administer naloxone. Many naloxone kits come with a syringe and a vial (seen in photo below) or a pre-filled cartridge of naloxone.

Can you buy Narcan over the counter in Texas? ›

The Food and Drug Administration (FDA) has approved over-the-counter sales of the opioid-reversing medication Narcan nasal spray – a move Texas physicians have long championed.

What is in a take home naloxone kit? ›

Each injectable naloxone kit includes: 1 hard case (for example, a zippered hard black case with red “naloxone” cross) 2 (0.4 mg/1 ml) vials or ampoules (a small glass container) of naloxone. 2 safety-engineered syringes with 25g, 1” needles attached.

What are the side effects of naloxone? ›

Approved by the FDA since the 1970s, naloxone is a very safe medication with the potential side effect of a theoretical risk of allergy that has never been documented. Its administration may result in acute opioid withdrawal (agitation, nausea, vomiting, diarrhea, "goose flesh", tearing, runny nose, and yawning).

What is the emergency use of naloxone? ›

Naloxone injection is used along with emergency medical treatment to reverse the life-threatening effects of a known or suspected opiate (narcotic) overdose. Naloxone injection is also used after surgery to reverse the effects of opiates given during surgery.

Can a normal person buy Narcan? ›

Do you need a prescription for Narcan? No. As of 2022, you can buy Narcan without a prescription from your healthcare provider in all 50 U.S. states. Washington D.C. and Puerto Rico also allow this.

How many doses of Narcan does a person need? ›

For nasal dosage form (Narcan® spray): Adults and children—At first, 2 or 4 milligrams (mg) (1 spray into one nostril). Another spray may be given into the other nostril every 2 to 3 minutes until the patient responds or until emergency medical assistance becomes available.

Is there a generic version of Narcan? ›

Is Narcan available as a generic? Narcan is available as the generic drug naloxone. Like the brand-name version, it comes as a nasal spray.

When should I recommend Narcan? ›

Physicians and physician assistants: When initiating opioid treatment, “Naloxone shall be prescribed for any patient when risk factors of prior overdose, substance misuse, doses in excess of 120 MME/day, or concomitant benzodiazepine are present.”

What are the barriers to getting naloxone? ›

Yet, there are several barriers to pharmacy-based naloxone distribution, including pharmacists' negative attitudes toward PWUD, a lack of clarity regarding their role in opioid overdose prevention, how pharmacies and pharmacists' workload are structured, variability in insurance coverage for naloxone, and having a ...

How do you administer Narcan? ›

Gently insert the tip of the nozzle into one nostril, until your fingers on either side of the nozzle are against the bottom of the person's nose. Press the plunger firmly to give the dose of Narcan® Nasal Spray. Remove the Narcan® Nasal Spray from the nostril after giving the dose.


1. FDA approves first over-the-counter drug for opioid overdose reversal
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2. The FDA approved the first over-the-counter nasal spray that can reverse an opioid overdose
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3. FDA approves overdose reversal drug for over-the-counter sale
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4. FDA approves Narcan as first over-the-counter opioid overdose-reversal drug
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5. Opioid overdose antidote Narcan will soon be available over the counter. Here's how to use it.
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6. FDA approves first over-the-counter version of opioid overdose antidote Narcan
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