Clonazepam (Clonazepam) - Summary

CLONAZEPAM SUMMARY

Clonazepam, a benzodiazepine, is available as an orally disintegrating tablet containing 0.125 mg, 0.25 mg, 0.5 mg, 1 mg or 2 mg clonazepam.

Seizure Disorders:

Clonazepam 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 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 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 clonazepam 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, 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: (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 clonazepam 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 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 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).

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Clinical Trials Related to 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

Clonazepam review by 19 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		anxiety/ panic attacks/ insomnia
Dosage & duration:		1mg twice daily (2mg daily total) taken as perscribed twice daily for the period of 1 year
Other conditions:		depression
Other drugs taken:		None that would sugnificantly interact
		Reported Results
Benefits:		The drug was taken for my daily anxiety caused by stress and also insomnia to help relax my body before bed. The drug is mainly intended for anxiety and works great at relieving those systems such as irregular heart beat, nervousness and other anxiety causing symptoms. I give it a 9 out of 10 for its performance.
Side effects:		The only thing i didnt like about this drug is that with taking it overtime I felt as if my body built tolerance to the drug as well as became more dependent on it. I still am until this day and have managed to ween off the drug. Then again every ones body is different, Just do your research before taking benzodiazepines long term.
Comments:		The treatment overall treated my anxiety quickly and effectively. No regrets. The drug overall has treated me effectively despite the minor drawbacks.

Clonazepam review by 52 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		agoraphobia, panic disorder
Dosage & duration:		2 mg at night taken every night for the period of since 1988
Other conditions:		none
Other drugs taken:		valium 5 mg as needed
		Reported Results
Benefits:		Taking the rivotril made me sleepy at first but then it just calmed me down enough to be able to cope with life. I was constantly anxious and scared and the rivotril made it possible for me to come down to relatively normal anxiety levels in "safe" situations, whereas before I didn't have any situations I considered safe. It helped me sleep and made me feel more rested and in control. I got pregnant while taking it (I had been trying for 18 years) and I honestly believe that being more relaxed helped me not only to get pregnant but to carry the baby as I had had four miscarraiges previously. I started confronting situations that were uncomfortable to me before and was able to live a reasonably normal life, even though I have become housebound. I feel the rivotril got me through a very tough time in my life.
Side effects:		The Rivotril didn't have any side effects in the long run, it made me a bit sluggish at first. However after taking it for a few years and feeling I no longer needed it, I found it impossible to stop taking it as the withdrawal symptoms were so bad. I have cut the dosage down considerably, from 5 mg at night to one, then I became nervous again and started taking 2 again. I have tried several times to come off the drug completely but the results have been tremors and feeling sick along with high anxiety to the point of hardly being able to speak. I would always go back on it. I never felt I needed MORE...I just coudn't stop taking even a small amount.
Comments:		I was told that panic attacks were caused by a chemical imbalance in the brain in the same area that caused epileptic fits. As Rivotril is a sedative and is given to people with epilepsy they had found that it also helped alleviate panic attacks. I was prescribed it for this reason. I am unable to take anti-depressants which also stop panic attacks because of strong side effects so this was a better choice for me at the time. I feel that it did the job, but had I known I would be on it for the rest of my life I'm not sure I would have started taking it. But maybe if I was desperate like I was then I would. I was concerned about taking it while pregnant but my child was normal. She did have bad withdrawal symptoms though after I stopped breast feeding her. No one realized that was what was happening when she cried all the time for seemingly no reason. Back then it was unknown that going off the drug caused withdrawal as the drug had never been used short term. Only for epileptics for life. She is 13 now and perfectly normal. However I do feel guilty about having put her through that.

Clonazepam review by 57 year old female patient
		Rating
Overall rating:
Effectiveness:		Marginally Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		Blepharospasm
Dosage & duration:		1 mg taken 1/day for the period of 3 months - still taking it
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		Very slight reduction in muscle spasms around eyes. Ended up also getting light Botox injections in eyelid muscles. This combo therapy has not resulted in a total cessation of eyelid spasms, but has reduced them enough so that I can drive again (the main disability caused by the blepharospasm). Taking the clonazepam at night also helps me get a better night's rest than before I took it.
Side effects:		The first few days I took it I was dizzy and very sleepy. However, those side effects have now subsided.
Comments:		Take 1 MG tab at night before bed. As mentioned above, also got Botox injections to reduce eyelid spasmx.