Gabapentin, Pregabalin, and Breathing

You take gabapentin for nerve pain or seizures, and someone just told you the pill can stop your breathing because an opioid is in the same day. Gabapentin and pregabalin are not opioids. They are gabapentinoids, and people take them for seizures, nerve pain, fibromyalgia, and restless legs syndrome, among other approved uses. On December 19, 2019, the Food and Drug Administration warned that serious breathing difficulties may occur when these medicines are used by people who already have respiratory risk factors. The risk factors FDA names are opioid pain medicines, other drugs that depress the central nervous system, and conditions such as chronic obstructive pulmonary disease that reduce lung function. Older adults are at higher risk too.

The communication says FDA required new warnings about respiratory depression on the prescribing information. It also required manufacturers to run clinical trials on abuse potential, especially when these drugs are combined with opioids, because misuse and abuse of the products together is increasing, and using them together may increase the risk of respiratory depression. The page lists its content as current as of December 19, 2019. What follows stays inside that communication. It is not a newer label review, and it is not a taper.

If breathing is slowed, shallow, or difficult, or you cannot wake the person, call 911. For a mental health crisis, call or text 988.

What FDA approved them to treat

FDA says gabapentinoids are approved for a variety of conditions, including partial seizures and nerve pain from spinal cord injury, shingles, and diabetes. Other approved uses include fibromyalgia and restless legs syndrome. Gabapentin was first approved in 1993. Pregabalin was first approved in 2004. The brand names in the warning are Neurontin, Gralise, and Horizant for gabapentin, and Lyrica and Lyrica CR for pregabalin. A tablet from a pain clinic and a capsule from a seizure clinic can be the same kind of drug. Read the generic name.

NIDA's three classes, opioids, central nervous system depressants, and stimulants, are the prescription-misuse guide. Gabapentinoids are not that list. They show up here because FDA put them next to opioids and other depressants in a breathing warning. The broader fact that two drugs together can be less predictable than one is the polysubstance guide.

What the breathing problem looks like

FDA tells patients and caregivers to get medical attention immediately if these symptoms show up, because they can be life-threatening:

• Confusion or disorientation
• Unusual dizziness or lightheadedness
• Extreme sleepiness or lethargy
• Breathing that is slowed, shallow, or difficult
• Unresponsiveness, which FDA defines as not answering or reacting normally, or being impossible to wake
• Bluish-colored or tinted skin, especially on the lips, fingers, and toes

That picture is the emergency already named above. Do not wait to see if a nap fixes extreme sleepiness when an opioid is also on board. A different boxed warning, about benzodiazepines and opioids used together, is the benzodiazepine-and-opioid guide. FDA's gabapentinoid note tells clinicians that a benzodiazepine is one example of a central nervous system depressant that should trigger the same caution: start low, and watch for sedation and slowed breathing. It does not fold gabapentin into the benzodiazepine class.

The opioid reversal medicine is the naloxone guide. This FDA communication does not say naloxone reverses gabapentin or pregabalin. If an opioid may be involved, use the naloxone page for what that medicine does, and still get emergency help.

What to tell the prescriber, and what not to do tonight

FDA says to tell your health care professional about every drug you take, including prescription medicines, over-the-counter medicines, and other substances such as alcohol. That list is the practical step. A clinician who does not know about the opioid, the benzodiazepine, or the alcohol cannot apply the warning. "Not a prescription" is not the same as "not a drug," which the over-the-counter guide explains.

For clinicians, FDA's instruction is to start gabapentinoids at the lowest dose and to monitor for respiratory depression and sedation when co-prescribing with an opioid or another central nervous system depressant such as a benzodiazepine. That sentence is about how a prescriber starts and watches a medicine. It is not a schedule a patient can copy. Do not cut a seizure medicine in half because you also take an opioid. Do not stop the opioid tonight because you also take gabapentin. Either change belongs to the prescriber, except when the emergency symptoms are already happening. Then the next step is emergency help, not a kitchen-table dose change.

The longer conversation about pain care and substance use is the chronic-pain guide. Methadone, buprenorphine, naltrexone, and why a pain taper is not the same decision as stopping those medicines, are the prescription-opioid guide. Gabapentin is none of those three.

What the warning does not settle

FDA said misuse of gabapentinoids with opioids is increasing, and that co-use may raise the risk of respiratory depression. "May" is the word in the communication. It is not a personal prediction, and it is not a finding that the medicine has no use. People take these drugs for seizures and for nerve pain because a prescriber decided the condition warranted them. The warning adds a breathing risk when lungs are already vulnerable or when other depressant drugs are present. It does not cancel the prescription from a distance.

The communication invites health professionals and patients to report side effects to FDA MedWatch. Reporting is optional. It is not a substitute for emergency care.

1. Is an opioid, a benzodiazepine, or alcohol in the same day as gabapentin or pregabalin?
2. Is there lung disease, or is the person older, in the way FDA flags higher risk?
3. Are any of the breathing or waking symptoms on FDA's list present right now?
4. Has every prescriber heard the full list, including medicines from another clinic?

Search FindTreatment.gov if what you need is treatment for substance use, not a dose change. SmarterRecovery is a referral helpline. SMART Recovery is a separate mutual-help program. Call or text (800) 653-9376 if you want help finding a program.

Additional Resources

Sources cited on this page:

• FDA Drug Safety Communication: serious breathing problems with gabapentin and pregabalin (posted December 19, 2019)
• SAMHSA FindTreatment.gov
• 988 Suicide & Crisis Lifeline

Common Questions