Sublingual Lorazepam Formulation Availability
No, there is no commercially available sublingual formulation of lorazepam approved by the FDA. 1
Current FDA-Approved Formulations
The FDA-approved lorazepam tablets are designed for oral administration only and are available in 0.5 mg, 1 mg, and 2 mg strengths 1. These tablets contain inactive ingredients including lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polacrilin potassium, and are specifically formulated for swallowing, not sublingual use 1.
Off-Label Sublingual Use in Clinical Practice
Despite the lack of a commercially available sublingual formulation, lorazepam is used sublingually off-label in clinical practice through two approaches:
1. Oral Tablets Used Sublingually
- Standard oral lorazepam tablets can be administered sublingually, though this is an off-label route 2
- Guidelines for delirium management in cancer patients specifically mention that lorazepam "can also be given p.o., s.l." at doses of 0.25-0.5 mg to 1-2 mg 2
2. Oral Concentrate Solution Used Sublingually
- Lorazepam oral concentrate solution can be administered sublingually and has demonstrated clinical efficacy 3
- In a study of 52 patients using sublingual lorazepam solution (median dose 1 mg, range 0.5-2 mg) for acute seizure treatment, 66% of patients with repetitive seizures had no further seizure activity, and 70% with prolonged seizures had cessation within 5 minutes 3
- No serious adverse events occurred with home doses of 0.5-2 mg, though 31% developed moderate/severe sedation 3
- A significant limitation is that 98% of patients refrigerated the solution, and 44% reported this limited treatment access 3
Clinical Context and Alternatives
When Sublingual Route Is Considered
The sublingual route for lorazepam is mentioned in guidelines primarily for:
- Crisis management of severe agitation and distress in delirious patients, particularly when combined with antipsychotics 2
- Acute seizure emergencies when IV access is unavailable 3, 4
- Premedication for procedures where amnesia is desired 5
Important Caveats
- Sublingual lorazepam use is entirely off-label and not FDA-approved for this route 1
- The bioavailability and pharmacokinetics of sublingual administration using oral formulations have not been rigorously established in FDA approval processes
- Older guidelines from 1996 specifically state that sublingual routes of benzodiazepines are "not recommended" for morphine, though this was in the context of opioid delivery rather than benzodiazepines specifically 6
FDA-Approved Alternatives for Non-Oral Benzodiazepine Administration
When oral administration is not possible, consider:
- Rectal diazepam (FDA-approved formulation available) 4
- Intranasal midazolam (recommended in consensus documents for out-of-hospital status epilepticus) 4
- Buccal midazolam (alternative non-oral route) 4
- Subcutaneous or intravenous lorazepam (FDA-approved parenteral routes) 2
Bottom Line
While lorazepam oral tablets and oral concentrate solution are used sublingually in clinical practice with some evidence of efficacy, this represents off-label use of an oral formulation, not a commercially available sublingual product 1, 3. Clinicians should be aware that this practice lacks FDA approval and formal pharmacokinetic validation for the sublingual route.