What is the recommended protocol for tapering Vortioxetine (Trintellix)?

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From the Guidelines

Vortioxetine (Trintellix) should be tapered gradually when discontinuing treatment to minimize withdrawal symptoms, with a recommended protocol of reducing the dose by 50% for 1 week, then discontinue completely after another week. For example, if a patient is taking 20 mg daily, reduce to 10 mg daily for one week, then 5 mg daily for one week before stopping. For patients on 10 mg daily, reduce to 5 mg daily for one week before discontinuation.

Key Considerations

  • Patients should be monitored during the tapering period for potential withdrawal symptoms such as irritability, anxiety, mood swings, dizziness, sensory disturbances, and headaches.
  • The gradual tapering is necessary because vortioxetine, like other antidepressants, can cause discontinuation syndrome when stopped abruptly.
  • If withdrawal symptoms emerge during tapering, a more gradual reduction schedule may be needed.
  • Patients should always consult with their healthcare provider before making any changes to their medication regimen. However, none of the provided studies 1 directly address the tapering of Vortioxetine (Trintellix), and the information provided is based on general principles of tapering antidepressants to minimize withdrawal symptoms.

From the FDA Drug Label

TRINTELLIX can be discontinued abruptly. However, it is recommended that doses of 15 mg/day or 20 mg/day be reduced to 10 mg/day for one week prior to full discontinuation if possible (2.3).

The recommended protocol for tapering Vortioxetine (Trintellix) is to reduce doses of 15 mg/day or 20 mg/day to 10 mg/day for one week prior to full discontinuation if possible 2.

  • Tapering recommendation: Reduce the dose to 10 mg/day for one week before stopping the medication.
  • Abrupt discontinuation: Although tapering is recommended, the medication can be discontinued abruptly if necessary. It is essential to follow this recommendation to minimize potential withdrawal symptoms 2.

From the Research

Tapering Vortioxetine (Trintellix)

To taper Vortioxetine, the following steps can be considered:

  • The US Food and Drug Administration recommends that doses of 15 mg/d or 20 mg/d be reduced to 10 mg/d for 1 week prior to full discontinuation to avoid potential withdrawal symptoms 3.
  • For patients who do not tolerate 20 mg/d, 10 mg/d can be used and a 5-mg/d dose can be considered 3.
  • A study on SSRI withdrawal syndrome suggests that tapers over a period of months and down to doses much lower than minimum therapeutic doses have shown greater success in reducing withdrawal symptoms 4.
  • Hyperbolically reducing doses of SSRIs, such as Vortioxetine, reduces their effect on serotonin transporter inhibition in a linear manner, which may help minimize withdrawal symptoms 4.

Key Considerations

  • Vortioxetine can be discontinued abruptly, but a taper is recommended to avoid potential withdrawal symptoms 3.
  • The pharmacokinetics of Vortioxetine are linear and dose proportional, with a mean terminal half-life of approximately 66 hours 5.
  • No clinically relevant differences were observed in Vortioxetine exposure by sex, age, race, body size, and renal or hepatic function, but dose adjustment is recommended for cytochrome P450 2D6 poor metabolizers 5.

Dose Reduction

  • A gradual dose reduction is recommended to minimize withdrawal symptoms.
  • The dose can be reduced by small increments, such as 2.5 mg or 5 mg, every 1-2 weeks, depending on the patient's tolerance and response 4.
  • The goal is to reach a dose that is low enough to minimize withdrawal symptoms, but still effective in managing depressive symptoms.

Patient Monitoring

  • Patients should be closely monitored during the tapering process for signs of withdrawal symptoms, such as nausea, headache, and dizziness 4.
  • The patient's depressive symptoms should also be monitored to ensure that the dose reduction does not lead to a relapse of symptoms 6.

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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