Klonopin (Clonazepam) - Summary

KLONOPIN SUMMARY

KLONOPIN^® TABLETS CIV
(clonazepam)
KLONOPIN^® WAFERS CIV
(clonazepam orally disintegrating tablets)

Klonopin, a benzodiazepine, is available as scored tablets with a K-shaped perforation containing 0.5 mg of clonazepam and unscored tablets with a K-shaped perforation containing 1 mg or 2 mg of clonazepam.

Klonopin is indicated for the following:

Seizure Disorders: Klonopin 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, Klonopin 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: Klonopin is indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-IV. 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 Klonopin was established in two 6- to 9-week trials in panic disorder patients whose diagnoses corresponded to the DSM-IIIR category of panic disorder (see CLINICAL PHARMACOLOGY: Clinical Trials).

Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, ie, 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: (1) palpitations, pounding heart or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes.

The effectiveness of Klonopin 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 Klonopin for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).

See all Klonopin indications & dosage >>

KLONOPIN NEWS HIGHLIGHTS

Published Studies Related to Klonopin (Clonazepam)

Clonazepam quantification in human plasma by high-performance liquid chromatography coupled with electrospray tandem mass spectrometry in a bioequivalence study. [2007.01]
A rapid, sensitive and specific method for quantifying clonazepam [generic for Klonopin] in human plasma using diazepam as the internal standard (IS) is described. The analyte and the IS were extracted from plasma by liquid-liquid extraction using a hexane/diethylether (20 : 80, v/v) solution... This HPLC/MS/MS procedure was used to assess the bioequivalence of two clonazepam 2 mg tablet formulations (clonazepam test formulation from Ranbaxy Laboratories Ltd and Rivotril from Roche Laboratorios Ltda as standard reference formulation).

Clonazepam for treatment of sleep disturbances associated with combat-related posttraumatic stress disorder. [2004.09]
BACKGROUND: Clonazepam [generic for Klonopin] is widely used for the treatment of posttraumatic stress disorder (PTSD)-related sleep disturbances despite very limited published data supporting its use for this indication. OBJECTIVE: We conducted a pilot-controlled trial to provide more data on this clinical practice and lay the foundation for more definitive studies... CONCLUSIONS: Clonazepam therapy was largely ineffective in improving sleep disturbances, particularly nightmares, associated with combat-related PTSD. The small sample size was a significant limitation of this study, but the prospective design and single-blind, placebo-control parameters were strengths. Further studies are needed to further define the role of this widespread clinical practice.

A double-blind combination study of clonazepam with sertraline in obsessive-compulsive disorder. [2004.07]
This double blind, randomized, parallel, placebo-controlled study investigates whether clonazepam [generic for Klonopin] accelerates and/ or increases the overall response in patients with obsessive compulsive disorder (OCD) who are treated with sertraline. Thirty-seven patients were randomized with 20 in the sertraline and clonazepam group and 17 in the sertraline and placebo groups...

Topical clonazepam in stomatodynia: a randomised placebo-controlled study. [2004.03]
Stomatodynia is characterised by a spontaneous burning pain in the oral mucosa without known cause or recognised treatment. The purpose of this double-blind, randomised, multicentre parallel group study was to evaluate the efficacy of the topical use of clonazepam [generic for Klonopin]...

Clonazepam and lorazepam in acute mania: a Bayesian meta-analysis. [2004.03]
BACKGROUND: Clonazepam [generic for Klonopin] and lorazepam are used in the treatment of acute mania but trial results are conflicting... CONCLUSIONS: This meta-analysis suggests that clonazepam is efficient and safe in the treatment of acute mania, but the results remain inconclusive for lorazepam.

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Clinical Trials Related to Klonopin (Clonazepam)

Bioavailability Study of Clonazepam Tablets Under Fasting Conditions [Completed]

Bioavailability Study of Clonazepam ODT Under Fasting Conditions [Completed]

Clonazepam and Paroxetine for Rapid Treatment of Post-Traumatic Stress Disorder [Completed]
Post-Traumatic Stress Disorder (PTSD) is an anxiety disorder that follows exposure to an extremely traumatic stressors. PTSD is associated with serious symptoms. While numerous approaches have been used to treat PTSD, these treatments have several limiting factors. This study will evaluate a combination of the drugs clonazepam and paroxetine for the treatment of PTSD symptoms.

The main goal of treatment in patients with PTSD is to significantly reduce symptom severity and improve functioning. While numerous approaches have been used to treat PTSD, these treatments are limited by variable response rates, up to a 6-week lag period before clinical response, and sub-optimal side effect profile, including possible worsening of anxiety and insomnia prior to clinical response. The proposed study will examine whether combined treatment with a benzodiazepine (clonazepam) and a selective serotonin reuptake inhibitor (paroxetine) in patients with PTSD will accelerate the onset of clinical response. A second goal is to evaluate whether the rapid and clinically meaningful benefits are sustained until the end of the study, despite tapering off the benzodiazepine at the midpoint of the study. The safety and tolerability of a combination of paroxetine and clonazepam will be compared to paroxetine and placebo (an inactive pill) in the treatment of PTSD.

Participants in this study will be randomly assigned to receive either paroxetine plus clonazepam or paroxetine plus a placebo for 12 weeks. Participants will have weekly clinic visits for the first 4 weeks of the study and every other week for the last 8 weeks. Symptoms of PTSD, anxiety, and depression will be evaluated and drug side effects will be noted during the follow-up visits.

Evaluation of Clonazepam and Paroxetine for Panic Disorder With Depression [Completed]
The purpose of this study is to examine the safety and effectiveness of the drug combination paroxetine and clonazepam in treating people with panic disorder (PD) and major depression.

The main goal in treating people with PD is to rapidly reduce symptom severity and improve functioning. While numerous drug therapies have been used to treat PD, these treatments are limited by variable response rates and suboptimal side effect profiles. Evidence suggests that clonazepam given with a selective serotonin reuptake inhibitor (SSRI) can facilitate a rapid reduction in PD symptoms. However, it is unclear whether comorbid depression influences treatment response to the clonazepam and SSRI regimen. This study will examine whether combined treatment with clonazepam and the SSRI paroxetine will accelerate clinical response in participants with PD and comorbid depression. This study will also examine whether the benefits of treatment will be sustained until the end of the study despite tapering of clonazepam at the midpoint of the study.

Participants in this study will be screened with medical and psychiatric interviews, a physical examination, electrocardiogram (ECG), and blood tests. Participants will then be randomly assigned to receive either paroxetine plus clonazepam or paroxetine plus placebo (an inactive pill) for 12 weeks. Participants will have weekly clinic visits during which symptoms and drug side effects will be checked and an interview to evaluate panic disorder and depression symptoms will be conducted.

Study of Intranasal Clonazepam in Adult Subjects With Epileptic Seizures [Recruiting]
Evaluate the safety and efficacy of intranasal Clonazepam in subjects with epilepsy.

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KLONOPIN PATIENT REVIEWS / RATINGS / COMMENTS

Klonopin review by 33 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		anxiety
Dosage & duration:		2mg taken three times daily for the period of 3 months
Other conditions:		obesity
Other drugs taken:		lessina
		Reported Results
Benefits:		decreased anxiety less insomnia
Side effects:		none
Comments:		one pill three times daily, including at beditime to facilitate sleep

Klonopin review by 23 year old male patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		Generalized anxiety disorder
Dosage & duration:		.25mg - .50mg taken x2/day for the period of 2 years
Other conditions:		Chronic pain, depression
Other drugs taken:		Various SSRIs, Welbutrin
		Reported Results
Benefits:		Very good at relieving anxiety. Good at generally calming me down and 'leveling me out' to make functioning easier. Helps a little to relax muscle tension. Calming effect makes an excellent sleep aid.
Side effects:		Fatigue can sometimes be excessive. High dependency.
Comments:		Used for general anxiety and as an adjunct for depression and chronic pain. Very good at alleviating any anxiety and jittery feelings. 'Levels out' my mood but doesn't cause euphoria; I have no desire to take more than I need. However I am very dependent on it; if I stop taking it for a couple of days I have bad nervousness and jitteryness, tachycardia, sweating, and other anxiety symptoms. If I wanted to discontinue I would have to do _very_ slowly, but this is the nature of long-term benzodiazepine treatment.

Klonopin review by 23 year old male patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		Generalized anxiety disorder
Dosage & duration:		.25mg - .50mg taken x2/day for the period of 2 years
Other conditions:		Chronic pain, depression
Other drugs taken:		Various SSRIs, Welbutrin
		Reported Results
Benefits:		Very good at relieving anxiety. Good at generally calming me down and 'leveling me out' to make functioning easier. Helps a little to relax muscle tension. Calming effect makes an excellent sleep aid.
Side effects:		Fatigue can sometimes be excessive. High dependency.
Comments:		Used for general anxiety and as an adjunct for depression and chronic pain. Very good at alleviating any anxiety and jittery feelings. 'Levels out' my mood but doesn't cause euphoria; I have no desire to take more than I need. However I am very dependent on it; if I stop taking it for a couple of days I have bad nervousness and jitteryness, tachycardia, sweating, and other anxiety symptoms. If I wanted to discontinue I would have to do _very_ slowly, but this is the nature of long-term benzodiazepine treatment.