Is nausea a Food and Drug Administration (FDA) approved indication for Ativan (lorazepam)?

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Is Nausea an FDA-Approved Indication for Ativan (Lorazepam)?

No, nausea is not an FDA-approved indication for Ativan (lorazepam). The FDA-approved indications for lorazepam are limited to anxiety disorders and short-term relief of anxiety symptoms, not nausea or vomiting 1.

FDA-Approved Uses vs. Off-Label Use

  • The FDA drug label for lorazepam does not list nausea or vomiting as approved indications 1.
  • Lorazepam is commonly used off-label as an adjunctive antiemetic, particularly in cancer-related nausea, but this represents off-label prescribing 2.
  • The FDA label does mention that gastrointestinal symptoms including nausea can occur as an adverse reaction to lorazepam, not as a treatment indication 1.

Role of Lorazepam in Nausea Management (Off-Label)

Lorazepam functions as a useful adjunct to antiemetic drugs but should never be prescribed as a single-agent antiemetic 3, 2. The American Society of Clinical Oncology explicitly states this limitation in their clinical practice guidelines 3.

When Lorazepam May Be Considered (Off-Label):

  • Anticipatory nausea and vomiting: Lorazepam (1 mg orally at bedtime the night before chemotherapy and 1 mg the morning of chemotherapy) may help with anxiety-related anticipatory nausea 2.
  • Breakthrough nausea: When patients fail first-line antiemetics, lorazepam can be added to the regimen at 0.5-2.0 mg every 4-6 hours (oral, IV, or sublingual) 3, 2.
  • Adjunctive therapy: In highly emetogenic chemotherapy regimens, lorazepam may be combined with a 5-HT3 antagonist, dexamethasone, and NK1 receptor antagonist 3.

First-Line Alternatives That ARE FDA-Approved:

  • 5-HT3 receptor antagonists (ondansetron, granisetron, palonosetron) are FDA-approved and represent the most effective first-line antiemetics 2, 4.
  • Dopamine receptor antagonists (metoclopramide, prochlorperazine, haloperidol) are FDA-approved for nausea and should be used before lorazepam 3, 5.
  • NK1 receptor antagonists (aprepitant, fosaprepitant) are FDA-approved for chemotherapy-induced nausea and vomiting 3.

Critical Clinical Pitfalls

  • Never prescribe lorazepam as monotherapy for nausea—this contradicts evidence-based guidelines and its lack of FDA approval for this indication 3, 2.
  • Lorazepam's primary mechanism is anxiolysis, not antiemesis—it reduces nausea indirectly by decreasing anxiety and promoting amnesia of the nausea experience 6, 7.
  • Significant adverse effects limit its use: sedation (15.9% incidence), dizziness (6.9%), weakness (4.2%), and potential for rebound anxiety and withdrawal symptoms with continued use 1, 8.
  • Memory impairment and confusion can occur, particularly problematic in elderly patients 1, 8.

Evidence Quality Assessment

The evidence supporting lorazepam for nausea is limited:

  • No high-quality RCTs demonstrate lorazepam's efficacy as a primary antiemetic 9.
  • One small study (N=22) of ABH gel (containing lorazepam, diphenhydramine, and haloperidol) showed no significant benefit over placebo 9.
  • Older studies from 1993 suggest lorazepam improves tolerability mainly through psychological effects and amnesia, not direct antiemetic action 6.
  • A 2017 study showed lorazepam reduced psychological distress and improved quality of life but was used in combination with other antiemetics 7.

Practical Recommendation

For nausea management, prescribe FDA-approved antiemetics first (5-HT3 antagonists, dopamine antagonists, or NK1 antagonists depending on the clinical scenario) 3, 2. Reserve lorazepam strictly as an adjunct when anxiety contributes to nausea or for anticipatory nausea in chemotherapy patients, and always document the off-label use 2.

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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