FDA-Approved Indications for Ativan (Lorazepam)
Lorazepam is FDA-approved for the management of anxiety disorders and for short-term relief of anxiety symptoms or anxiety associated with depressive symptoms. 1
Primary FDA Indication
- Anxiety disorders and anxiety symptoms: Lorazepam is indicated for managing anxiety disorders or providing short-term relief of anxiety symptoms, including anxiety associated with depressive symptoms. 1
- Not for everyday stress: Anxiety or tension related to everyday life stress does not require anxiolytic treatment. 1
- Duration limitation: The effectiveness of lorazepam for long-term use (beyond 4 months) has not been established by systematic clinical studies. 1
FDA-Approved Dosing for Anxiety
- Standard adult dosing: The usual range is 2-6 mg/day in divided doses, with the largest dose taken before bedtime; daily dosage may vary from 1-10 mg/day. 1
- Initial anxiety dosing: Most patients require 2-3 mg/day given twice or three times daily. 1
- Insomnia due to anxiety: A single daily dose of 2-4 mg may be given, usually at bedtime, for insomnia related to anxiety or transient situational stress. 1
- Elderly or debilitated patients: Initial dosage of 1-2 mg/day in divided doses is recommended, adjusted as needed and tolerated. 1
Off-Label Uses Supported by Guidelines
While not FDA-approved, lorazepam is widely used for several conditions with guideline support:
- Alcohol withdrawal syndrome: Lorazepam 1-4 mg PO/IV/IM every 4-8 hours is recommended for patients with severe AWS, advanced age, liver failure, respiratory failure, or other serious comorbidities. 2
- Insomnia (off-label): Short-acting benzodiazepines like lorazepam may be considered for insomnia when the duration of action is appropriate or when comorbid conditions might benefit, though not specifically FDA-approved for this indication. 2
- Delirium management: 1 mg subcutaneously or intravenously stat, up to 2 mg maximum, for delirium in palliative care settings. 3
- Status epilepticus (pediatric): 0.05-0.10 mg/kg IV over 2 minutes, maximum single dose 5 mg. 3, 4
Critical Safety Considerations
- Withdrawal risk: Gradual taper is required when discontinuing to reduce withdrawal reactions, including rebound insomnia and anxiety. 1
- Rebound phenomena: Withdrawal can cause marked worsening of sleep above baseline levels (rebound insomnia) and increased tension/anxiety, with peak withdrawal effects occurring on the third night after discontinuation. 5, 6
- Tolerance and dependence: Regular use can lead to tolerance, addiction, depression, and cognitive impairment. 4
- Paradoxical reactions: Approximately 10% of patients experience paradoxical agitation. 4
- Cognitive effects: Side effects include memory impairment, confusion, anterograde amnesia, and severe hangover, particularly with higher doses. 6