Klonopin (Clonazepam) - Summary

KLONOPIN SUMMARY

KLONOPIN^® TABLETSCIV
(clonazepam)
KLONOPIN^® WAFERS CIV
(clonazepamorally 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).

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NEWS HIGHLIGHTS

Published Studies Related to Klonopin (Clonazepam)

Defense style changes with the addition of psychodynamic group therapy to clonazepam in social anxiety disorder. [2009.07]
Psychodynamic Group Therapy (PGT) and clonazepam are strategies to reduce symptoms of generalized social anxiety disorder (GSAD).Neurotic defense style can change toward greater adaptiveness with the addition of PGT to clonazepam in GSAD, even in 12 weeks.

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 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 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 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...

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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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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:		Moderate Side Effects
		Treatment Info
Condition / reason:		panic disorder
Dosage & duration:		1mg taken daily for the period of 1 year
Other conditions:		anxiety, depression
Other drugs taken:		effexor
		Reported Results
Benefits:		It has the effect of major Reduction in anxiety, it produces alot of calmness, able to function properly, they pills cured insomnia, it made me get less sever panic attacks, reduction and or elimination of panic attacks, it improveded mood.It was the best drug for panic attacks
Side effects:		They are very addictive and lose effectiveness over time. You become dependent on them and you need more and more to reduce your anxiety. It is very difficult to get off this drug. It make you gain wait and you have to get off of it eventually. You have to get off them slowly
Comments:		i took the drug for a long time and wit was really amazing and i like it and it was awewesome and it was afucn and it was cool and it was sweet but it was verry addicting and it sohouldnt be used for a long period of time because it losses effectiness over time

Klonopin review by 38 year old female patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		Extremely Severe Side Effects
		Treatment Info
Condition / reason:		Insommnia
Dosage & duration:		1mg taken most nights for the period of 1 year
Other conditions:		None
Other drugs taken:		Low dose doxepin
		Reported Results
Benefits:		Initially did help with sleep. Over time tolerance developed and depression and grogginess ensued.
Side effects:		On attempting to withdraw very severe side effects of withdrawal that lasted over one year: personality changes, anxiety, severe sleeplessness. A disaster!
Comments:		Withdrawal had to be done very slowly over several months. I would NEVER use benzodiazepines ever again. They are for single use only. Have since learned that even after a few days use there can be rebound effects. These drugs are dangerous. Period.