GABITRIL (tiagabine HCl) is an antiepilepsy drug available as 2 mg, 4 mg, 12 mg, and 16 mg tablets for oral administration. Its chemical name is (-)-(R)-1-[4,4-Bis(3-methyl-2-thienyl)-3-butenyl]nipecotic acid hydrochloride, its molecular formula is C H NO S HCl, and its molecular weight is 412.0. Tiagabine HCl is a white to off-white, odorless, crystalline powder. It is insoluble in heptane, sparingly soluble in water, and soluble in aqueous base.
GABITRIL (tiagabine hydrochloride) is indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures.
Media Articles Related to Gabitril (Tiagabine)
Breast cancer drug found to reduce seizures
Source: Breast Cancer News From Medical News Today [2016.05.13]
Findings from animal study could lead to improved seizure treatment in humans.
Algorithms that can predict epileptic seizures
Source: Epilepsy News From Medical News Today [2016.05.12]
Computer scientists and mathematicians at the CEU Cardenal Herrera University in Valencia have developed a prediction model that can warn epileptic sufferers of an upcoming seizure with 20 minutes...
Brain signals between seizures may explain memory problems in patients with epilepsy
Source: Epilepsy News From Medical News Today [2016.04.26]
Study suggests how future devices might prevent cognitive deficits. Between seizures and continually, brain cells in epileptic patients send signals that make "empty memories," perhaps explaining...
Novartis drug Afinitor significantly reduces seizures in Phase III study of patients with tuberous sclerosis complex
Source: Epilepsy News From Medical News Today [2016.04.22]
Everolimus is the first adjunctive therapy shown in a prospective randomized Phase III study to achieve clinically significant seizure control in TSC patients1.
Once-a-day epilepsy drug may prevent seizures as well as twice-a-day drug
Source: Epilepsy News From Medical News Today [2016.04.14]
A new study suggests that an epilepsy drug that can be taken once a day may control seizures as well as a drug that must be taken twice a day, according to a preliminary study presented at the...
Published Studies Related to Gabitril (Tiagabine)
Tiagabine add-on for drug-resistant partial epilepsy. 
CONCLUSIONS: Tiagabine reduces seizure frequency but is associated with
Pregabalin effect on steady-state pharmacokinetics of carbamazepine, lamotrigine, phenobarbital, phenytoin, topiramate, valproate, and tiagabine. [2011.02]
By reducing neuronal excitability through selective binding to the alpha(2)delta subunit of voltage-dependent calcium channels, pregabalin effectively treats epilepsy, chronic pain, and anxiety disorders. To evaluate if pregabalin coadministration affects pharmacokinetics of other antiepileptic drugs, population pharmacokinetic analyses using NONMEM software were performed on data from three epilepsy trials involving seven antiepileptic drugs with pregabalin as add-on therapy...
Tiagabine for social anxiety disorder. [2007.06]
Tiagabine, a selective gamma-aminobutyric acid (GABA) reuptake inhibitor was evaluated for the treatment of patients with social anxiety disorder (SAD). Adults with SAD received open-label tiagabine 4-16 mg per day for 12 weeks...
Tiagabine does not attenuate alcohol-induced activation of the human reward system. [2007.05]
RATIONALE: The rewarding effects of ethanol and other drugs of abuse are mediated by activation of the mesolimbic dopamine system. Recent neuroimaging studies in primates and humans suggest that cocaine-induced dopamine stimulation might be diminished by drugs augmenting gamma-aminobutyric acid A (GABA-A) receptor function such as the GABA transaminase inhibitor vigabatrin. OBJECTIVES: The objective of this study was to test the property of the selective GABA transporter 1 (GAT1) inhibitor tiagabine to block ethanol-induced activation of the mesolimbic reward system in an i.v. ethanol challenge... CONCLUSIONS: Our ethanol challenge imaging study does not provide supporting evidence that the GAT1 inhibitor tiagabine diminishes the rewarding effects of ethanol. Further PET imaging studies using established anticraving compounds, such as the mu-opioid receptor antagonist naltrexone and antiepileptic drugs affecting the GABA-ergic system more broadly, will provide additional important insights on the interaction between the GABA-ergic and the brain reward system in vivo and the suitability of GABA-ergic drugs as anticraving compounds.
Comparison of the cognitive effects of tiagabine and carbamazepine as monotherapy in newly diagnosed adult patients with partial epilepsy: pooled analysis of two long-term, randomized, follow-up studies. [2006.07]
PURPOSE: Patients with epilepsy are at greater risk for cognitive impairment than are age- and education-matched controls. Cognitive decline is a significant adverse event associated with many first-generation anticonvulsant drugs (AEDs); however, the past decade has seen the introduction of several new AEDs with more-favorable cognitive profiles. Tiagabine (TGB) is indicated as adjunctive therapy for the treatment of partial seizures. The cognitive effects of TGB and carbamazepine (CBZ) monotherapy were evaluated in adult epilepsy patients with partial seizures... CONCLUSIONS: The results of this 52-week, follow-up study show that successful TGB monotherapy with 20-30 mg/day has a cognitive profile similar to that of successful long-term CBZ monotherapy with 400-800 mg/day in newly diagnosed patients with epilepsy and to that of untreated patients with a single seizure. We observed no significant decline in cognitive scores associated with TGB monotherapy.
Clinical Trials Related to Gabitril (Tiagabine)
Evaluate the Safety of GABITRIL in Adults With Generalized Anxiety Disorder [Completed]
To assess the long-term safety and tolerability of tiagabine treatment in patients with
generalized anxiety disorder (GAD).
Study to Evaluate the Safety and Efficacy of GABITRIL Treatment in Adults With Generalized Anxiety Disorder. [Completed]
A 12-Month, Open-Label, Flexible-Dosage Study to Evaluate the Safety and Efficacy of
GABITRIL Treatment in Adults with Generalized Anxiety Disorder.
Tiagabine to Enhance Slow Wave Sleep in Patients With Sleep Apnea [Recruiting]
Obstructive sleep apnea (OSA) is common and has major health implications but treatment
options are limited. Interestingly, the severity of OSA is profoundly reduced in deep sleep
(called "slow wave sleep"), potentially via an increase in the stimulus required to arouse
from sleep. Here the investigators test the idea that the medication called "tiagabine"
improves slow wave sleep and reduces OSA severity. The investigators will also test whether
tiagabine raises the arousal threshold (more negative esophageal pressure), and whether
detailed OSA "phenotyping" characteristics can predict the improvement in OSA severity with
Effectiveness of Tiagabine for Cocaine Dependence in Methadone-Maintained Individuals - 1 [Completed]
Many opioid-dependent individuals are also dependent on cocaine. Methadone is a widely used
and effective method for treating opioid dependence. However, it is not effective in
treating other drugs of abuse. The purpose of this study is to determine the effectiveness
of another drug, tiagabine, for treating cocaine dependence in opioid-dependent individuals
already receiving methadone treatment.
Switching From an SSRI to Tiagabine(GABITRIL) in Order to Alleviate SSRI Induced Sexual Dysfunction [Completed]
Anxious patients are now treated with Selective Serotonin Reuptake Inhibitor medications
(common antidepressants) which elevate serotonin and thus alleviate anxiety. These
medications have clearly proven efficacy upwards of 70% for many anxiety disorders. In
regards to tolerability, they have a major problem in that they often produce sexual
dysfunction in men and women (ie. decreased libido, anorgasmia, impotence) upwards of 30% of
Benzodiazepine anxiolytics are also FDA approved to treat anxiety with equal efficacy and
greater tolerability (very little, if any sexual dysfunction). They do, however, carry a
substantial risk for addiction. Tiagabine is a Selective GABA Reuptake Inhibitor (SGRI)
that is FDA approved to treat certain types of epilepsy. Like benzodiazepines, Tiagabine
also increases the neurotransmitter, GABA, in the brain and is thought to alleviate anxiety
(see references below) this way too, but without any addiction risk common to Valium-type
drugs. The safety profile of Tiagabine is thought to be much safer. Two double blind
studies are ongoing which are looking at Tiagabine's effectiveness in PTSD and GAD. There
are many open label studies showing anxiety reduction and many psychiatrists in clinical
practice are utilizing this agent as an anxiety treatment in an off-label manner.
This study is designed to evaluate anxious patients who are taking SSRI medication, have had
a reasonable response, but are experiencing significant sexual side effects which are
pushing them towards noncompliance and possible relapse into anxiety. 30 subjects (15 men
and 15 women) will be asked to join the study and be placed on Tiagabine as well as their
current SSRI. Once an acceptable dose of Tiagabine is reached in the first four weeks, the
subjects' SSRIs will be slowly stopped. Two weeks after enrollment, all subjects will be
called in order to check for any side effects to the study drug and to insure that each
subject is titrating to the proper dose of study drug according to the study protocol. An
open-label, non-placebo prospective 10 week follow up will occur, where the now Tiagabine
monotherapy subjects will be followed to see primarily if their sexual dysfunction improves
and if there anxiety remains controlled.
Reports of Suspected Gabitril (Tiagabine) Side Effects
Status Epilepticus (4),
Drug Ineffective (3),
Confusional State (2),
Intentional Overdose (2),
Loss of Consciousness (2),
Coordination Abnormal (2), more >>
Page last updated: 2016-05-13