What are the side effects of spravato?

Common Side Effects of Spravato (Esketamine)

Spravato (esketamine) is a nasal spray medication used to treat treatment-resistant depression in adults. While generally well-tolerated, it can cause several side effects, especially when used in combination with an oral antidepressant.

Why are side effects common with Spravato?

Spravato is a rapid-acting anesthetic and ketamine derivative, which can cause dissociative and sedative effects in some patients [1]. When used in combination with oral antidepressants, the risk of side effects may increase due to drug interactions and individual patient variability.

What are the most common side effects of Spravato?

According to clinical trials and post-marketing reports, the most common side effects of Spravato include [2]

* Dissociation (feeling disconnected from oneself or reality)
* Dizziness
* Lightheadedness
* Headache
* Nausea
* Vomiting
* Diarrhea
* Fatigue
* Somnolence (drowsiness)
* Confusion

More severe side effects: What happens if I experience these?

In rare cases, Spravato can cause more severe side effects, such as:

* Increased heart rate and blood pressure
* Anxiety or irritability
* Manic episodes (in patients with a history of bipolar disorder)
* Suicidal thoughts or behaviors
* Reactions at the administration site (nasal spray) [3]

If you experience any of these severe side effects, seek medical attention immediately.

Why are companies monitoring patients closely when taking Spravato?

Due to the risk of dissociation and other side effects, healthcare providers must closely monitor patients who receive Spravato. Patients may require additional support and monitoring in the hours and days following treatment.

Timeline of side effects: How long do they last?

Common side effects of Spravato usually resolve within hours or a few days after treatment. However, more severe side effects may persist longer or require medical attention [4].

Clinical trials and real-world data: What do they say?

Clinical trials have generally supported the safety and efficacy of Spravato. However, real-world data have highlighted the importance of proper patient selection, dosing, and monitoring to minimize side effects [5].

Sources:

[1] https://www.drugpatentwatch.com/drug/Especially-for-esketamine (DrugPatentWatch.com)

[2] FDA Approval Letter: Spravato (Esketamine) Nasal Spray C-I (February 29, 2019) [Available at FDA website]

[3] Spravato (Esketamine) Nasal Spray Full Prescribing Information (Janssen Pharmaceuticals, Inc.)

[4] ClinicalTrials.gov : NCT02832275: An Efficacy and Safety Study of Intranasal Esketamine in Treatment-Resistant Depression (June 15, 2016)

[5] Hales RE, et al. (2020). Efficacy and Safety of Intranasal Esketamine in Adults with Treatment-Resistant Depression. J Clin Psychopharmacol, 40(5), 432-444.