For individuals grappling with treatment-resistant depression (TRD), a comprehensive understanding of medication effects is paramount in making informed decisions about their health journey. Spravato (esketamine) is a prescription drug approved to treat depression in certain situations, specifically treatment-resistant depression and major depressive disorder involving active suicidal thoughts or behaviors, always prescribed with another oral antidepressant.
One common concern among patients considering Spravato treatment relates to its potential impact on body weight and metabolism. Unlike many traditional antidepressants that can significantly impact weight, Spravato (esketamine) has shown a different metabolic profile. Research indicates that Spravato’s effects on body weight are generally minimal, making it an attractive option for patients concerned about weight-related side effects.
Does Spravato Cause Weight Gain?
No, weight gain wasn’t a side effect reported in people using Spravato in the drug’s studies. Weight gain is not a reported side effect of Spravato. Weight gain was not reported in clinical trials of the drug. Studies thus far have not shown weight gain as a prominent side effect.
Selective serotonin reuptake inhibitors (SSRIs), such as fluoxetine (Prozac), the drug mirtazapine (Remeron), and older antidepressants called tricyclic antidepressants (TCAs), such as amitriptyline, are more prone to causing weight gain than Spravato.
You may take Spravato alone or with other medications for treating depression. It’s possible that other medications you take for this condition may cause weight gain as a side effect. Your doctor or pharmacist can tell you more about antidepressants that are less likely to cause weight gain.
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Understanding Spravato
Spravato is a brand-name nasal spray that’s prescribed for certain types of depression in adults. It is an FDA-approved esketamine intranasal spray that has emerged as a breakthrough in treating people with severe or treatment-resistant depression. The Spravato nasal spray is the only treatment of its type, and the only FDA-approved form of ketamine therapy for treating depression.
Esketamine is made from a drug called ketamine, an anesthetic that has also been used for many years to treat depression. Esketamine is derived from part of the ketamine molecule. Because it’s more potent, you can use it at a lower dose and theoretically have fewer side effects.
Esketamine, like ketamine, has the potential to distort your perception during the first two hours after treatment, so it has to be administered in a clinic setting. With the nasal spray, you give yourself three doses, spaced five minutes apart, under doctor supervision.
Esketamine must be used in conjunction with a conventional antidepressant. Usually, the treatment is given twice a week for the first month, and then if it is successful it is continued at decreased frequency in a maintenance phase for a few weeks or months with dosing and frequency determined by treatment response.
Currently, esketamine is approved for people with treatment-resistant depression. For people who haven’t had success with other antidepressants, esketamine gives them the chance to see what it’s like to not have depression.
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Esketamine’s antidepressant function works through a different mechanism than other drugs. Conventional antidepressants increase levels of naturally occurring chemicals such as serotonin, norepinephrine, and dopamine. These chemicals are messengers that relay communication between brain cells. Esketamine works in a similar fashion, but unlike other antidepressants it increases levels of glutamate, the most abundant chemical messenger in the brain.
Common antidepressants are slow-acting. It often takes several weeks to make a noticeable difference in how people with depression feel. Conventional antidepressants may actually increase suicidal thoughts at the beginning of treatment, especially in children and young adults. Esketamine is the only drug besides lithium, a drug commonly prescribed for bipolar disorder, that’s proven to decrease suicidal thoughts.
Up to 33% of people with depression don’t respond to multiple kinds of conventional antidepressants. The only other approved drug therapy for treatment-resistant depression is a combination of olanzapine (an antipsychotic drug) and fluoxetine (a conventional antidepressant).
Research suggests that untreated depression causes long-term brain damage and is a risk factor for dementia. Studies show that people with depression have up to 20% shrinkage of the hippocampus, a region of the brain critical for memory and learning. Animal studies indicate that connections between brain cells diminish under chronic stress, but esketamine reverses these stress-related changes.
Ketamine consists of two molecules, R-ketamine and S-ketamine, which each have slightly different effects on the brain. Esketamine is a form of ketamine that has been slightly modified to contain only S-ketamine, specifically in order to treat depression.
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Spravato isn’t a first-line treatment for depression. It is specifically and exclusively used for treating adults (over the age of 18) with severe depression or those who have not experienced relief in their symptoms from other treatments.
IV ketamine infusions are another type of ketamine therapy used to treat depression. While there have been promising results from IV ketamine infusions in treating depression, it has more severe side effects than Spravato and is not FDA-approved, which means it is not as controlled. It is also a very expensive treatment and not covered by insurance.
Clinical Evidence
When it comes to Spravato and weight gain, clinical evidence suggests that there is no significant link. In the SUSTAIN-1 and SUSTAIN-2 trials, weight changes among patients using Spravato were minimal. Similarly, the ESCAPE-TRD study reported that only 2.7% of patients on Spravato experienced increased weight, compared to 12.5% with another antidepressant, QUE-XR. The FDA’s patient medication guide also does not list weight gain as a common side effect of Spravato.
Other Factors Influencing Weight
While Spravato itself isn’t a major cause of weight gain, other factors can influence weight changes during treatment. Depression itself can alter eating behaviors, sometimes leading to overeating or binge eating as coping mechanisms, or else avoiding food altogether. Moreover, oral antidepressants often prescribed alongside Spravato can contribute to weight fluctuations. Personal differences also play a crucial role in how weight might change.
Common and Mild Side Effects of Spravato
Like most medications, Spravato can cause mild side effects. These side effects can vary depending on which condition the drug is prescribed for. Most of these side effects are temporary, lasting anywhere between a few days to a few weeks. It’s important to note that Spravato is typically prescribed alongside an oral antidepressant, such as sertraline (Zoloft) or fluoxetine (Prozac). Keep in mind that some side effects may be due to the oral antidepressant rather than Spravato.
Examples that have been reported include:
- Altered sense of taste
- Anxiety
- Constipation
- Diarrhea
- Dizziness
- Dry mouth
- Feeling anxious
- Feeling as if you’re drunk
- Headache
- Insomnia
- Irritation or discomfort in your nose or throat
- Lack of energy and mental alertness
- Lethargy (feeling sluggish and unmotivated)
- Mild allergic reaction
- Mild sedation
- Nausea and vomiting
- Numbness, including in your nose or mouth
- Vertigo (the feeling that your surroundings are moving or spinning)
In most cases, these side effects should be temporary. And some may be easily managed. But if you have symptoms that are ongoing or bother you, talk with your doctor or pharmacist. And don’t stop Spravato treatment unless your doctor recommends it.
Serious Side Effects of Spravato
Serious side effects are possible with Spravato treatment. The Food and Drug Administration (FDA) has highlighted these serious side effects as risks with Spravato use in boxed warnings. If you develop serious side effects during Spravato treatment, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.
Serious side effects that have been reported include:
- Risk of Sedation, Dissociation, and Respiratory Depression: Spravato may cause feelings of sedation (extreme sleepiness). The drug may also cause dissociation (feeling disconnected from yourself or your thoughts). It’s also possible to experience respiratory depression (slow and ineffective breathing) with Spravato treatment.
- Risk of Misuse: Treatment with Spravato may cause dependence, and it’s possible to misuse this drug.
- Risk of Suicidal Thoughts and Behaviors: Like other antidepressant drugs, Spravato can increase the risk of suicidal thoughts and behaviors in people ages 24 years and younger.
- Serious Urinary Tract or Bladder Problems: This includes inflammation of your bladder.
- Cognitive Impairment: Spravato treatment may cause cognitive impairment.
- Temporary Increase in Blood Pressure: You may have a temporary increase in blood pressure after receiving a dose of Spravato.
- Severe Allergic Reaction: An allergic reaction is possible after using Spravato.
Risk of Sedation, Disassociation, and Respiratory Depression Explained
Spravato has a boxed warning about the risk of sedation, dissociation, and respiratory depression. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about the most serious side effects that drugs such as Spravato may cause.
Spravato may cause feelings of sedation (extreme sleepiness). The drug may also cause dissociation (feeling disconnected from yourself or your thoughts). It’s also possible to experience respiratory depression (slow and ineffective breathing) with Spravato treatment.
Dissociation was the most common side effect, and sedation was among the most common side effects in Spravato’s studies. In rare cases, sedation led to a loss of consciousness. Respiratory depression wasn’t a side effect that was reported in studies, but it has been reported since the drug was approved.
In addition to feeling disconnected from yourself or your thoughts, dissociation can cause symptoms such as:
- A burning or prickling sensation in your body, such as in your arms, hands, legs, or feet
- Feeling cold or hot
- Hallucinations
- Ringing in your ears
- Vision changes, including blurred vision
Your risk of dissociation from Spravato is higher if you have or have had psychosis.
What might help:
Before prescribing Spravato, your doctor will assess your risk of sedation, dissociation, and respiratory depression. If you have received a diagnosis of psychosis, your doctor may decide to prescribe a treatment other than Spravato.
If your doctor prescribes Spravato, you’ll receive doses of the drug in a healthcare setting, such as your doctor’s office or a clinic. Your doctor or another healthcare professional will monitor you for at least 2 hours after each dose. Tell your doctor right away if you feel like you can’t stand up or are going to pass out after getting a dose of Spravato.
After at least 2 hours, your doctor will check in with you to determine when you’re ready to leave the clinic or office. Due to the risk of sedation, you’ll need to have someone else drive you home after getting your Spravato dose. And you should avoid driving or operating machinery on the day of your treatment. Only resume these activities after waiting at least 1 day and getting a full night’s sleep.
Due to the risk of respiratory depression, your doctor or the healthcare professional will also monitor your breathing for at least 2 hours after a dose of Spravato. This will include checking your blood oxygen levels.
Risk of Suicidal Thoughts and Behaviors Explained
Spravato has a boxed warning about the risk of suicidal thoughts and behaviors. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about the most serious side effects that drugs such as Spravato may cause.
Like other antidepressant drugs, Spravato can increase the risk of suicidal thoughts and behaviors in people ages 24 years and younger. (Spravato is only approved for adults ages 18 years and older.) This risk is highest during the first few months of treatment or when the dose is changed.
Suicidal thoughts were reported in Spravato’s studies, but this side effect was not common. Self-harm was rare in these studies when the drug was used in adults with depression who were actively having suicidal thoughts or behaviors.
It’s important to note that having depression is also a risk factor for suicidal thoughts and behaviors.
What might help:
Your doctor will monitor you for worsening depression or suicidal thoughts or behaviors throughout your treatment with this drug. You should also let loved ones or friends know that you are taking Spravato to treat your depression. They can help watch for changes in your mood.
If you develop suicidal thoughts or behaviors during treatment with Spravato, your doctor may suggest stopping this drug.
Temporary Increase in Blood Pressure Explained
You may have a temporary increase in blood pressure after receiving a dose of Spravato.
In studies, these increases were highest about 40 minutes after getting a dose. They lasted about 4 hours on average. In some instances, these increases were high enough to cause concern.
Mild increases in blood pressure don’t usually cause symptoms. But if your blood pressure becomes high enough, it could cause serious symptoms such as:
- Chest pain
- Problems thinking or concentrating
- Seizure
- Severe, sudden headache
- Shortness of breath
- Vision problems
Due to these risks, doctors usually won’t prescribe Spravato for people with certain conditions that an increase in blood pressure could seriously worsen. These conditions include:
- Aneurysmal vascular disease (a blood vessel disease)
- Arteriovenous malformation (an atypical connection between your arteries and veins)
- Intracranial hemorrhage (a history of bleeding in your brain)
Your doctor can explain the risks and benefits of Spravato if you have certain other medical conditions that an increase in blood pressure could worsen. These include:
- High blood pressure
- History of heart attack or stroke
- Heart failure
- Heart valve disease
- History of injury to your brain
What might help:
Before starting Spravato treatment, tell your doctor about any medications you take and the conditions you may have. Your doctor can help determine whether this drug is safe for you.
Before each dose of Spravato, your doctor will check your blood pressure. If your blood pressure reading is high that day, your doctor may delay your dose until it returns to acceptable levels for you.
After each dose of Spravato, your doctor or another healthcare professional will monitor you for at least 2 hours. This includes monitoring your blood pressure. If you have symptoms of dangerously high blood pressure or a very high reading, they can refer you for emergency care. This may involve treatment in an emergency room or hospital.
Cognitive Impairment Explained
Spravato treatment may cause cognitive impairment. But this side effect was temporary in the drug’s studies, peaking about 40 minutes on average after people received a dose. This side effect went away after about 1 to 2 hours. Long-term cognitive impairment wasn’t reported in anyone during Spravato’s studies.
But long-term cognitive impairment has happened in people who have used ketamine frequently and for a long time. (Spravato contains the active drug esketamine, which is very similar to ketamine).
Symptoms of cognitive impairment can include:
- Memory problems
- Difficulty with concentrating or carrying out tasks, such as planning your day or doing math
What might help:
After each dose of Spravato, your doctor or another healthcare professional will monitor you for at least 2 hours. This includes monitoring your cognition, which they’ll confirm is satisfactory before clearing you to leave. You should avoid driving or operating machinery on the day you receive a Spravato dose. Only resume these activities after waiting at least 1 day and getting a full night’s sleep. This is to be sure your cognition returns to how it was before you took your dose.