Applies to sufentanil: sublingual tablet. Other dosage forms:
- injection solution
Warning
Sublingual route (Tablet)
Accidental exposure to or ingestion of sufentanil sublingual tablets, especially in children, can result in respiratory depression and death. Because of the potential for life-threatening respiratory depression due to accidental exposure, sufentanil sublingual tablets are only available through a restricted program called the Dsuvia REMS Program. Sufentanil sublingual tablets must only be dispensed to patients in a certified medically supervised healthcare setting. Discontinue use of sufentanil sublingual tablets prior to discharge or transfer from the certified medically supervised healthcare setting.Serious, life-threatening, or fatal respiratory depression may occur with the use of sufentanil sublingual tablets. Monitor for respiratory depression, especially during initiation of sufentanil sublingual tablets.Sufentanil sublingual tablets exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing sufentanil sublingual tablets, and monitor all patients regularly for the development of these behaviors or conditions.Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of sufentanil.Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants including alcohol, may result in profound sedation, respiratory depression coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
Serious side effects of Sufentanil
Along with its needed effects, sufentanil may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur while taking sufentanil:
Less common
- Blurred vision
- confusion
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- sweating
- unusual tiredness or weakness
Rare
- Bloody urine
- blue lips, fingernails, or skin
- burning feeling in the chest or stomach
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest pain or discomfort
- decreased frequency or amount of urine
- decreased urine output
- difficult or troubled breathing
- difficulty in passing urine (dribbling)
- extremely shallow or slow breathing
- fainting
- fast heartbeat
- increased blood pressure
- increased thirst
- indigestion
- irregular, fast or slow, or shallow breathing
- lightheadedness, dizziness or fainting
- loss of appetite
- lower back or side pain
- nausea
- painful urination
- seeing, hearing, or feeling things that are not there
- severe constipation
- severe vomiting
- slow or irregular heartbeat
- stomach pain or upset
- swelling of the face, fingers, or lower legs
- tenderness in the stomach area
- troubled breathing
- unusual drowsiness, dullness, or feeling of sluggishness
- vomiting
- weakness
- weight gain
Incidence not known
- Agitation
- cough
- darkening of the skin
- diarrhea
- difficulty swallowing
- fever
- hives, itching, skin rash
- mental depression
- overactive
- reflexes
- poor coordination
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- restlessness
- shivering
- talking or acting with excitement you cannot control
- tightness in the chest
- trembling or shaking
- twitching
Get emergency help immediately if any of the following symptoms of overdose occur while taking sufentanil:
Symptoms of overdose
- Blue lips and fingernails
- blurred vision
- chest pain
- choking
- cold and clammy skin
- constricted pupils
- coughing that sometimes produces a pink frothy sputum
- decreased awareness or responsiveness
- difficult or troubled breathing
- irregular, fast or slow, or shallow breathing
- loss of consciousness
- pale or blue lips, fingernails, or skin
- severe sleepiness
- slow heartbeat
- swelling in the legs and ankles
Other side effects of Sufentanil
Some side effects of sufentanil may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Headache
Rare
- Anxiety
- belching
- bloated
- confusion about identity, place, and time
- difficulty having a bowel movement (stool)
- drowsiness
- dry mouth
- excess air or gas in the stomach or bowels
- false or unusual sense of well-being
- feeling of warmth
- forgetfulness
- full feeling
- heartburn
- indigestion
- muscle spasm
- passing gas
- redness of the face, neck, arms and occasionally, upper chest
- sleepiness or unusual drowsiness
- trouble sleeping
For Healthcare Professionals
Applies to sufentanil: compounding powder, injectable solution, sublingual tablet.
General
The most commonly reported adverse events with the sublingual tablet have been nausea, headache, vomiting, dizziness, and hypotension; with the injectable formulation, apnea, rigidity, and bradycardia have been commonly reported.[Ref]
Respiratory
Common (1% to 10%): Respiratory depression
Uncommon (0.1% to 1%): Apnea
Rare (less than 0.1%): Hypoxia, bradypnea, hiccups, atelectasis, hypoventilation, respiratory distress, respiratory failure
Frequency not reported: Respiratory arrest[Ref]
Hypersensitivity
Anaphylaxis has been reported with ingredients contained in the sufentanil sublingual tablet.[Ref]
Uncommon (0.1% to 1%): Hypersensitivity
Postmarketing reports: Anaphylaxis[Ref]
Cardiovascular
Common (1% to 10%): Increased heart rate, increased blood pressure, decreased blood pressure
Uncommon (0.1% to 1%): Decreased heart rate, hypotension
Rare (less than 0.1%):: Bradycardia, sinus tachycardia, flushing
Frequency not reported: Severe bradycardia, severe hypotension including orthostatic hypotension, syncope[Ref]
Musculoskeletal
Common (1% to 10%): Involuntary muscle spasms, muscle twitching
Frequency not reported: Muscle rigidity, muscle movement[Ref]
Gastrointestinal
Very common (10% or more): Nausea (29%; sublingual tablet), vomiting
Common (1% to 10%): Constipation, dyspepsia
Uncommon (0.1% to 1%): Dry mouth
Rare (less than 0.1%): Flatulence, diarrhea, dry mouth, eructation, retching, abdominal discomfort, abdominal distension, abdominal pain upper, gastritis, postoperative ileus, hypoesthesia oral
Opioids:
Frequency not reported: increase in serum amylase[Ref]
Psychiatric
Common (1% to 10%): Confusional state
Uncommon (0.1% to 1%): Apathy, nervousness
Rare (less than 0.1%): Memory impairment, insomnia, confusional state, anxiety, agitation, disorientation, euphoric mood, hallucination, mental status changes
Frequency not reported: Addiction, abuse, misuse[Ref]
Nervous system
Cases of serotonin syndrome have been reported during concomitant use of opioids with serotonergic drugs.[Ref]
Very common (10% or more): Headache (12.1%; sublingual tablet)
Common (1% to 10%): Dizziness, sedation
Uncommon (0.1% to 1%): Somnolence, paresthesia, ataxia, dystonia, hyperreflexia
Rare (less than 0.1%): Pre-syncope, lethargy
Frequency not reported: Seizures, coma
Opioids:
Postmarketing reports: Serotonin syndrome[Ref]
Dermatologic
Very common (10% or more): Pruritus (up to 25%)
Uncommon (0.1% to 1%): Hyperhidrosis, rash, dry skin
Frequency not reported: Erythema[Ref]
Genitourinary
Common (1% to 10%): Urinary retention
Rare (less than 0.1%): urinary hesitation, oliguria[Ref]
Ocular
Uncommon (0.1% to 1%): Vision disturbances
Frequency not reported: Miosis[Ref]
Other
Very common (10% or more): Pyrexia
Uncommon (0.1% to 1%): Chills, asthenia
Frequency not reported: Drug withdrawal syndrome[Ref]
Endocrine
Cases of adrenal insufficiency have been reported with opioid use of greater than 1-month duration. Cases of androgen deficiency have occurred with chronic opioid use.[Ref]
Opioids:
Postmarketing reports: Adrenal insufficiency, androgen deficiency[Ref]
Renal
Rare (less than 0.1%): Renal failure
