FDA label

What is clonazepam used for?

The FDA-approved uses of clonazepam, quoted from the Indications and Usage section of its DailyMed label.

Source: DailyMed SPL label file dated 2026-10-23. Publisher page

The FDA label for clonazepam (tablet, orally disintegrating) lists 2 uses: Seizure Disorders:; Panic Disorder:.

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Clonazepam, tablet

Indications and Usage, quoted from the label by Advagen Pharma Ltd (ANDA075468). Cross-references to other label sections are left out.

Seizure Disorders:

Clonazepam tablets are useful alone or as an adjunct in the treatment of the Lennox- Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam tablets may be useful.

Some loss of effect may occur during the course of clonazepam treatment (see PRECAUTIONS: Loss of Effect).

Panic Disorder:

Clonazepam tablets are indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-V. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks.

The efficacy of clonazepam tablets was established in two 6- to 9-week trials in panic disorder patients whose diagnoses corresponded to the DSM-lIlR category of panic disorder (see CLINICAL PHARMACOLOGY: Clinical Trials).

Panic disorder (DSM-V) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: palpitations, pounding heart or accelerated heart rate; sweating; trembling or shaking; sensations of shortness of breath or smothering; feeling of choking; chest pain or discomfort; nausea or abdominal distress; feeling dizzy, unsteady, lightheaded or faint; derealization (feelings of unreality) or depersonalization (being detached from oneself); fear of losing control; fear of dying; paresthesias (numbness or tingling sensations); chills or hot flushes.

The effectiveness of clonazepam tablets in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. The physician who elects to use clonazepam tablets for extended periods should periodically reevaluate the long- term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).

Source: DailyMed label, set id 30d674f9-f1b3-4c2d-a8e9-3bc8e476f1ec, version 4, effective June 25, 2026. NDC 72888-152, one of 117 listings for this product.

Clonazepam, tablet, orally disintegrating

Indications and Usage, quoted from the label by Par Health USA, LLC (ANDA077171). Cross-references to other label sections are left out.

Seizure Disorders:

Clonazepam orally disintegrating tablet is useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam orally disintegrating tablets may be useful.

In some studies, up to 30% of patients have shown a loss of anticonvulsant activity, often within 3 months of administration. In some cases, dosage adjustment may reestablish efficacy.

Panic Disorder:

Clonazepam orally disintegrating tablet is indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-V. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks.

The efficacy of clonazepam orally disintegrating tablets was established in two 6- to 9-week trials in panic disorder patients whose diagnoses corresponded to the DSM-lllR category of panic disorder (see CLINICAL PHARMACOLOGY: Clinical Trials ).

Panic disorder (DSM-V) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: palpitations, pounding heart or accelerated heart rate; sweating; trembling or shaking; sensations of shortness of breath or smothering; feeling of choking; chest pain or discomfort; nausea or abdominal distress; feeling dizzy, unsteady, lightheaded or faint; derealization (feelings of unreality) or depersonalization (being detached from one­self); fear of losing control; fear of dying; paresthesias (numbness or tingling sensations); chills or hot flushes.

The effectiveness of clonazepam orally disintegrating tablets in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. The physician who elects to use clonazepam orally disintegrating tablets for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION ).

Source: DailyMed label, set id 1aef0069-80ea-483d-ac70-c8d485462c5b, version 27, effective October 6, 2025. NDC 49884-306, one of 25 listings for this product.

Questions

What is clonazepam used for?

The FDA label for clonazepam (tablet, orally disintegrating) lists 2 uses: Seizure Disorders:; Panic Disorder:.

What drug class is clonazepam?

FDA lists clonazepam in the Benzodiazepine established pharmacologic class.

Does this page cover off-label uses or dosing?

No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.

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