Dsuvia (Sufentanil) - Sublingual

What Is Dsuvia?

Dsuvia (sufentanil) is an acute (short-term) medication option for the management of acute pain severe enough to require an opioid analgesic (prescription medications used to treat serious pain) and for which alternative treatments are insufficient. Dsuvia is used in adults 18 and older

Dsuvia is defined as an opioid agonist. Opioid agonists are therapeutic drugs used for the management of opioid dependency. Opioids themselves are naturally occurring or synthetic substances that have morphine-like properties.

Dsuvia works by attaching to opioid receptors (binding sites).

As a generic product, sufentanil is available via intravenous (IV) injection. Sufentanil is also available via IV injection under the brand name Sufenta Preservative Free.

Dsuvia is a prescription product that's administered in the form of sublingual (SL) tablets and is the primary focus of this article. Individuals can take these tablets by placing them under the tongue under the supervision of a healthcare provider in a healthcare setting.

What Is Dsuvia Used For?

Dsuvia is used for acute (short-term) severe pain when other pain relievers aren't effective.

Many people experience pain every once in a while—with acute pain usually lasting up to four weeks.

Dsuvia, however, has a lot of restrictions. For example, this medication should be used only for a maximum of 72 hours (three days). Plus, healthcare providers can give Dsuvia to you only in a medical setting, such as an emergency department (ED), a surgical center, or a hospital.

Your healthcare provider and the medical facility also need to be certified with the REMS program.

The purpose of these restrictions is to prevent serious side effects, such as dangerously slow breathing rate, overdose, coma, and death.

SUD is also a concerning side effect of Dsuvia. Based on a 2019 national survey, roughly 10 million people reported misusing opioid prescriptions, and more than 1.5 million people had opioid use disorder (OUD) within the previous year.

Between July 2019 and June 2020, human-made opioids—other than methadone—were also linked to over 48,000 deaths.

How to Take Dsuvia

You can receive Dsuvia only from a healthcare provider in a medical setting, such as an ED, a surgical center, or a hospital.

The following is additional information on what to expect when you're taking Dsuvia in one of these settings.

• Your healthcare provider will give you ice chips if your mouth is dry.
• Your healthcare provider will ask you to open your mouth and lift your tongue to touch the roof of your mouth.
• Your healthcare provider will place Dsuvia underneath your tongue.
• Let the tablet dissolve. Don't chew or swallow the tablet.
• Try not to eat, drink, or talk for 10 minutes after receiving Dsuvia from your healthcare provider.
• Your healthcare provider will give Dsuvia to you only as needed.
• Your healthcare provider will not give more than one tablet every hour or 12 tablets within 24 hours.
  

Storage

You can receive Dsuvia only from your healthcare provider.

Therefore, you do not need to worry about how to store the medication or how to travel with it.

What Are the Side Effects of Dsuvia?

This is not a complete list of side effects, and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 800-FDA-1088.

Common Side Effects

Common side effects with Dsuvia may include:

• Dizziness
• Headache
• Hypotension (low blood pressure)
• Nausea or vomiting
  

Severe Side Effects

The FDA assigned a black box warning to Dsuvia:

Accidentally or unintentionally taking this medication—especially in children—may result in a seriously slowed breathing rate and death. For this reason, Dsuvia is available only through a REMS program. Combining this medication with certain medications may further increase your risk of severely slowed breathing rate, overdose, coma, and death.

Dsuvia may also raise your risk of SUD.

Only healthcare providers should give this medication in a medical setting. This allows the healthcare provider to closely monitor for severe side effects and stop the medication before you leave the medical setting.

Serious side effects with Dsuvia may include:

• Severe allergic reaction: If you have a severe allergic reaction to Dsuvia, symptoms may include itchiness, swelling, and breathing problems.
• Dangerously slow breathing rate and death: Dangerously slow breathing rate and death may happen from accidentally or unintentionally taking Dsuvia—especially in children.
• Overdose: There's a chance of overdose with Dsuvia. Dsuvia overdoses might result in a seriously slow breathing rate, coma, and death. This risk is further increased when Dsuvia is taken with certain medications.
• Sleep-related breathing problems: Dsuvia raises your risk of sleep-related breathing problems, such as sleep apnea.
• SUD: Dsuvia may raise your risk of substance use disorder. This risk is more likely if you have a history of SUD. Symptoms of SUD may include changes in appetite, behavior, mood, or vision.
• Serotonin syndrome: Dsuvia may increase your risk of a rare but life-threatening condition called serotonin syndrome, which is a condition of high serotonin levels. Your risk is further increased if you take Dsuvia with other medications that raise serotonin levels. Symptoms of serotonin syndrome may include seizures, sweating, and tremors.
• Adrenal insufficiency is sometimes known as Addison's disease. People with this medical condition don't make enough of certain hormones, such as cortisol. Symptoms of adrenal insufficiency may include dizziness, tiredness, weakness, nausea, and vomiting.
• Low blood pressure and slow heart rate: While low blood pressure is a common side effect of Dsuvia, it can become severe and excessive. This may occur when you're changing positions—like from sitting down to standing up. Some people might also experience a slow heart rate with Dsuvia. Symptoms of postural (positional) low blood pressure and slow heart rate may include feeling lightheaded and faint.

Immediately let your healthcare provider know if your symptoms feel life-threatening.

Long-Term Side Effects

Dsuvia is generally taken for a maximum of 72 hours. This isn't typically considered long-term use.

Potential long-term side effects with Dsuvia, however, will likely include some of its serious side effects, such as adrenal insufficiency, SUD, and death.

Long-term opioid use might also be linked to fertility problems. During pregnancy, long-term Dsuvia use may also raise the likelihood of withdrawal side effects in your newborn baby.

Suddenly stopping long-term Dsuvia use, on the other hand, may raise your chances of discontinuation (withdrawal) side effects.

Dosage: How Much Dsuvia Should I Take?

You can take Dsuvia only in a medical setting (e.g., emergency department, surgical center, or hospital). At one of these settings, your healthcare provider will give Dsuvia to you as needed for the short-term relief of severe pain.

Modifications

The following modifications (changes) should be kept in mind when using Dsuvia:

Severe allergic reaction: Avoid using Dsuvia if you have a known allergy to it or any of its ingredients. Ask your healthcare provider for a complete list of the ingredients if you're unsure.

Pregnancy: In rat and rabbit animal studies, sufentanil was found to have negative effects on the fetus. We don't know enough about the safety and effectiveness of Dsuvia in pregnant people and on the unborn fetus.

In general, during pregnancy, long-term opioid use may raise the risk of withdrawal side effects in your newborn baby. These withdrawal side effects may include diarrhea, irritability, high-pitched cries, tremors, and vomiting. Some newborns may also have abnormal sleeping schedules and problems with weight gain.

Discuss with your healthcare provider if you plan to become pregnant or are pregnant. They can help you weigh the benefits and risks of Dsuvia during your pregnancy.

Breastfeeding: Sufentanil is likely to present in human breast milk. Little information, however, is available about the safety and effects of Dsuvia in human breast milk and nursing babies.

If you're going to take Dsuvia while breastfeeding, your healthcare provider will likely monitor your child for excessive sleepiness, feeding problems, breathing difficulties, and weak or low muscle tone.

Talk with your healthcare provider if you plan to breastfeed. They will help you weigh the benefits and risks of Dsuvia while nursing. They can also discuss the different ways available to feed your baby.

Older adults over 65: Based on limited data, older adults tend to have more nausea than younger adults. A dangerously slow breathing rate is also more likely to happen in older adults.

In general, older adults with several medical conditions or who are taking several medications should use caution. Older adults tend to be more sensitive to side effects from medications.

Children: There is little information about the effectiveness and safety of Dsuvia in children. In fact, Dsuvia isn't currently recommended for children.

Kidney or liver problems: Individuals with kidney or liver problems may not be able to clear the medication from their bodies as easily. This means the medicine stays in the body longer and can have increased side effects.

For this reason, if you have severe kidney or liver impairment, your healthcare provider will closely monitor you for side effects.

Lung conditions: People with lung conditions—like chronic obstructive pulmonary disease (COPD)—might have a higher risk of breathing problems with Dsuvia. Your healthcare provider will likely want to monitor you closely.

Sleep apnea: People taking opioids—like Dsuvia—have a higher risk of developing sleep-related breathing problems, such as sleep apnea. If you already have sleep apnea, Dsuvia may worsen your breathing problems. Your healthcare provider may want to closely monitor you for a dangerously slow breathing rate.

People with high pressure on the brain, brain tumors, or head injury: If you have high pressure on the brain or brain tumors, Dsuvia may further increase pressure on the brain and raise your risk of having a severely slow breathing rate. Dsuvia may also confuse the overall picture of how you're actually doing with a head injury. Your healthcare provider will closely monitor your brain-related conditions and Dsuvia side effects.

Seizures: Dsuvia may raise your risk of seizures, especially if you have a seizure condition. For this reason, your healthcare provider will closely monitor your seizure condition.

History of SUD: Dsuvia may raise your risk of developing substance use disorder. This risk is further increased if you have a history of SUD.

People with cachexia (wasting syndrome): Dsuvia may severely lower your breathing rate. This risk is further increased for people with cachexia. In cachexia, you're in a weakened state because your body is wasting away. This is typically a result of a medical condition. Your healthcare provider will likely closely monitor you for side effects from Dsuvia.

Certain digestive system-related conditions: If you have a digestive system–related condition, Dsuvia may worsen your symptoms. Pancreatitis is an example of a digestive system–related condition. In pancreatitis, your pancreas is inflamed (swollen). Symptoms of pancreatitis may include stomach pain, fever, nausea, and vomiting.

Missed Dose

Dsuvia is typically given as needed for a maximum of 72 hours by healthcare providers in a medical setting, such as an ED, a surgical center, or a hospital. So it's unlikely that you'll miss a Dsuvia dose.

Overdose: What Happens If I Take Too Much Dsuvia?

The symptoms of a suspected overdose of Dsuvia may include:

• Abnormal snoring
• Cold and clammy skin
• Coma
• Dangerously slow breathing rate
• Death
• Excessive drowsiness or sleepiness
• Pulmonary edema (fluid in the lungs)
• Limp muscles
• Low blood pressure
• Pupil changes
• Bradycardia (slow heart rate)
• Tightening (narrowing) of your throat

If you think that you're experiencing an overdose or life-threatening symptoms, seek immediate medical attention.

Precautions

What Are Reasons I Shouldn’t Take Dsuvia?

Before taking Dsuvia, talk with your healthcare provider if any of the following applies to you:

Severe allergic reaction: If you have a severe allergic reaction to Dsuvia or any of its components (ingredients), this medication isn't a viable option for you.

Dangerously slow breathing rate: If you currently have a severely slow breathing rate, Dsuvia may worsen this. For this reason, this medication should be avoided.

Asthma: Dsuvia may affect how you breathe. For this reason, it should be avoided if you have an asthma attack or severe asthma in a setting without monitoring from your healthcare provider and without rescue equipment.

Coma: Dsuvia isn't recommended during a coma.

Severely low blood pressure and slow heart rate: While low blood pressure is a common side effect of Dsuvia, it can become severe and excessive. Dsuvia should be avoided if you're having a very slow heart rate or unstable blood pressure that isn't providing enough blood flow to the rest of your body.

Digestive system blockage: Dsuvia isn't recommended if you have a blockage in your digestive system. Paralytic ileus is an example of a medical condition that may result in a blockage in your digestive system.

In paralytic ileus, your intestines stop moving food and other contents along your digestive system. Dsuvia may worsen this condition.

Pregnancy: We don't know enough about the safety and effectiveness of Dsuvia in pregnant people and on the unborn fetus. In general, during pregnancy, long-term opioid use may raise the risk of withdrawal side effects in your newborn baby.

These withdrawal side effects may include diarrhea, irritability, high-pitched cries, tremors, and vomiting. Some newborns may also have abnormal sleeping schedules and problems with weight gain.

Discuss with your healthcare provider about the benefits and risks of Dsuvia during pregnancy.

Breastfeeding: Sufentanil is likely to present in human breast milk. Little information, however, is available about the safety and effects of Dsuvia in human breast milk and nursing babies.

If you're going to take Dsuvia while breastfeeding, your healthcare provider will likely monitor your child for excessive sleepiness, feeding problems, breathing difficulties, and weak or low muscle tone.

Talk with your healthcare provider about the benefits and harms of Dsuvia while breastfeeding.

Older adults over 65: Based on limited data, older adults tend to have more nausea than younger adults. A dangerously slow breathing rate is also more likely to happen in older adults. In general, older adults should use caution.

Children: There is little information about the effectiveness and safety of Dsuvia in children. In fact, Dsuvia isn't currently recommended for children.

What Other Medications May Interact With Dsuvia?

Use caution when taking Dsuvia with the following medications:

CYP3A4-inhibiting medications: CYP3A4 is a liver protein that's responsible for breaking down certain medications, such as Dsuvia. CYP3A4-inhibiting medications prevent CYP3A4 from working as well.

So there might be a build-up of Dsuvia in your body, leading to a higher likelihood of side effects if you are taking one of these types of medications. Examples of CYP3A4 inhibitors may include ketoconazole (an antifungal) and erythromycin, an antibiotic.

CYP3A4-inducing medications: CYP3A4-inducing medications have the opposite effect on CYP3A4 when compared to CYP3A4 inhibitors. CYP3A4 inducers encourage CYP3A4 to quickly break down Dsuvia.

This may result in lower Dsuvia levels and lower effectiveness. Examples of CYP3A4 inducers may include Tegretol (carbamazepine) and Dilantin (phenytoin) for seizures.

Central nervous system (CNS) depressants: The CNS includes the brain and the spinal cord. CNS depressants tend to have a slowing effect on the CNS.

For this reason, they will likely worsen some of Dsuvia's side effects, such as slow breathing rate, low blood pressure, and excessive drowsiness or sleepiness.

Examples of CNS depressants may include alcohol, benzodiazepines (e.g., Ativan [lorazepam]), muscle relaxers (e.g., Zanaflex [tizanidine]), and other opioids.

Serotonergic medications: Serotonergics are medications that may raise the levels of a naturally occurring chemical called serotonin. Combining these medications with Dsuvia may further raise serotonin levels, increasing the risk of serotonin syndrome.

Serotonin syndrome is a rare but life-threatening condition. Symptoms may include sweating, seizures, and tremors. Examples of serotonergics may include selective serotonin reuptake inhibitor (SSRI) antidepressants—like Zoloft (sertraline)—and monoamine oxidase inhibitors (MAOIs)—like selegiline for depression or Parkinson's disease (PD).

In fact, Dsuvia should be avoided with current MAOI use and for 14 days after stopping your MAOI.

Medications that work against Dsuvia may decrease its effectiveness. ReVia (naltrexone) is an example medication that works against Dsuvia. Naltrexone is an opioid antagonist that attaches to opioid receptors (binding sites), blocking opioid effects. Naltrexone can be used for OUD.

Anticholinergic medications: In general, anticholinergic medications stop a naturally occurring chemical called acetylcholine. Anticholinergics may worsen some of Dsuvia's side effects, such as constipation, which raises the risk of paralytic ileus.

In paralytic ileus, your intestines stop moving along food and other contents, resulting in a blocked digestive system. An example of an anticholinergic drug includes Vesicare (solifenacin) for overactive bladder (OAB).

For more detailed information about medication interactions with Dsuvia, talk with your healthcare provider.

Also talk with your healthcare provider about any other medicines you take or plan to take, including over-the-counter, nonprescription products, vitamins, herbs, or plant-based medicines.

What Medications Are Similar?

Several opioids are used to relieve pain. Dsuvia is a Schedule II controlled prescription, in the 4-anilidopiperidine class of human-made opioids.

Therefore, the following medications are most similar to Dsuvia.

• Alfenta (alfentanil)
• Actiq (fentanyl)
• Ultiva (remifentanil)

All 4-anilidopiperidines are available as intravenous injections. You may see these medications given with anesthesia before a procedure. Alfentanil and remifentanil, however, aren't available in any other dosage forms.

Sufentanil and fentanyl, on the other hand, do have other dosage forms. Aside from IV injections, Dsuvia is also available as an SL tablet taken only in a medical setting, such as an ED, a surgical center, or a hospital.

As for fentanyl, it has several more dosage forms. Aside from IV injections, fentanyl is available in a patch that you place on your skin. The fentanyl patch is used to relieve chronic (long-term) severe pain when other options didn't help.

Fentanyl is also available as a lozenge and buccal tablet that you can place between the cheek and gums to allow the lozenge or tablet to dissolve inside your mouth. The buccal tablet can also dissolve underneath your tongue.

The lozenge and buccal tablets are typically used for breakthrough pain in people with cancer. Breakthrough pain might happen with these individuals who have already taken chronic opioids to control their cancer pain.

Compared to all of the other 4-anilidopiperidines, fentanyl is the only one with options that can be used outside a medical setting.

While healthcare providers can prescribe more than one opioid for your symptoms, many will try to limit combining multiple opioids. If you have questions or concerns, reach out to your healthcare provider.

How Can I Stay Healthy While Taking Dsuvia?

Living with pain can be difficult. Work with your healthcare provider to establish goals that are reasonable and achievable. In addition to Dsuvia or other pain relievers, your healthcare provider may suggest other potentially helpful strategies.

The following are some possible recommendations:

• Avoid pain triggers
• Introduce more anti-inflammatory foods into your eating pattern
• Find ways to relax
• Practice yoga and other exercises
• Try acupuncture
• Quit smoking
• There may be a link between depression, adverse childhood experiences, and chronic pain. If this is the case for you, consider working with a licensed mental healthcare provider that's ideally trauma informed.