Sunday, 17 June 2012

Anxiolytics Drugs Definition | Dependence, Side effects, Action, Abuse


Anxiolytics

An effective anxiolytic agent should reduce anxiety with little or no effect on motor and mental function
·         Benzodiazepines (BZDs)
·         Barbiturates (BARBs)
·         5-HT1A receptor agonists
·         Carbamates
·         Others:TCAs (fluvoxamine), MAOIs, Antihistaminicagents, B-Adrenoreceptor antagonists, Antipsychotics (Ziprasidone)

Overdose effects of an ideal antianxiety/sedative agent should not include generalized CNS depression. Therapeutic Index, margin of safety is greater for 2nd generation agents thatn for 1st generation agents. While increasing the dose, anxiolytics may give effects of sedation to hypnosis and anesthesia
First generation - eg. barbiturates
2nd generation - eg. benzodiazepines
3rd generation - Selective antianxiety, eg.buspirone

GABA receptors Classification
3 major subtypes of trans-membrane proteins
GABA A - 5 subunits, coassemble to form an integral, involves ionotropic chloride channel
GABA B - it is single, G protein-coupled, metabotropic receptor
GABA C - ligand-gated chloride channel, function and pharmaco properties are different from GABA A & B

GABA A Receptors
GABA A receptors is a glycoprotein pentamer belonged to of ligand-gated ion channelfamily
The GABA A receptor-chloride ionophore complex is made of 5 subunits, alfa, beta and gamma that co-assemble to form an integral chloride channel
There are 6 subtypes of alfa, and 3 each of beta and gamma
GABA binds to a site on the alfa or beta subunit
The receptor also contains binding sites for benzodiazepines, barbiturates and steroids such as progesterone (distinct from the GABA-binding site)

Functional Diversity of the GABA A Receptor Subunits
alfa1 subunit - containing GABA A receptors: sedation
alfa2 subunit - anxiolysis
alfa3 subunit - processing of sensory motor information related to a schizophrenia endophenotype
alfa4 subunit - sedative, hypnotic and anesthetic effects of some agents in the thalamus
alfa5 subunit - (extrasynaptic): associative temporal and spatial memory by inhibitory modulation of activities in the hippocampus
beta3 subunit - sedation, hypnosis, and anesthesia

GABA Function and Distribution
Inhibitory neurotransmitter that modulate chloride anion permeability
Widely distributed thoughout central nervous system
Local inhibitory action, therefore rapidly alters neuronal output
GABA is responsible for overall level of inhibitory tone in the brain

GABA binds to GABA A receptors --> causes conformational changes --> open the chloride ion channel --> lead to neuronal membraine hyperpolarization --> inhibitory neurotransmission in the CNS

Barbiturates
Now largely obsolete as anxiolytic and are mainly used in anesthesia (thiopental) and epilepsy (phenobarbital)
Taking BARBs with other CNS depressants can be extremely dangerous and may even lethal
Examples include: alcohol, tranquillizers, opioids (heroin, morphine, codeine or methadone), and antihistamines (found in cold, cough, and allergy remedies)

Barbiturate Mechanism of Action
Enhance  GABAnergic Transmission
-increase opening time of GABAnergic channels both in the presence or absence of GABA
-increase receptor affinity for GABA
However, they bind to a different site of the GABA A - receptor / chloride channel. At high concentrations they may be GABA-mimetic
Barbiturates are less selective than benzodiazepines, they also:
-depress actions of excitatory neurotransmitters
-exert nonsynaptic membrane effects

Disadvantages of Barbiturates
-increase toxicity compared to benzodiazepenes
-psychological dependence
-physiological tolerance: No tolerance to lethal action of drug
-strongly induce hepatic CYP450 & conjugating enzymes > increase metabolism of many other drugs
-flumazenil not effective
-death may occur by overdose (often choice to commit suicide)

In low doses, have a tranquilizing effect. As dose increases, hypnotic or sleep inducing effect. Even large doses actas anticonvulsants and anesthetics. Barbiturates has small therapeutic index.
Sedation > hypnosis > anesthesia > coma > death

Barbiturates Adverse effects
-excessive CNS depression
-hypersensitivity reactions
-excitement
-respiratory depression and hypotension
-coma and death in overdose

Benzodiazepines List of Examples
Chlordiazepoxide (Benpine, oldest)
Diazepam (Valium)
Bromazepam (Lexotan)
Lorazepam (Ativan)
Chlorazepate (Tranxene)
Alprazolam (Xanax)
Clonazepam
Oxazepam
Prazepam

Benzodiazepines Mechanism of Action
Involvement of endogenous ligands of the BDZ receptors is suspected.
BDZ bind selectively to GABA A receptors, in which binding of BDZs to gamma subunits of GABA A facilitates the process of channel opening
BDZs enhance the GABAnergic transmission by
-increase the frequency of openings of GABAergic channels
-increase receptor affinity for GABA
Serotonergic effects may result, eg. clonazepam

Benzodiazepines bind to GABA A receptors (gamma subunit) > act allosterically to increase the affinity of GABA > facilitate the opening of the Cl- ion channel - increased chloride permeability. Hence, BDZ potentiate GABA by increasing neuronal inhibition and CNS depression especially limbic system.

Benzodiazepiens therapeutic uses
Reduction of anxiety and agression
Sedation and induction of sleep
-anxiolysis (20% receptor occupancy with alfa2)
-sedation (30-50% receptor occupancy with alfa1)
-hypnosis (>60% receptor occupancy)
In addition, BDZ are used in/as:
-alcohol withdrawal
-pre-anesthetic medications
-reduction of muscle tone and coordination
-anticonvulsant
-anterograde amnesia

Benzodiazepines
Advantages
-higher therapeutic index
-relatively safe even if overdose
-have little effect on respiratory depression
-muscle relaxation (useful for spasm & back pain)
-can treat seizures (clonazepam)

Disadvantages
-interaction with alcohol
-long-lasting 'hangover' effects
-withdrawal symptoms
-development of TOLERANCE

Pharmacokinetics of Benzodiazepines
Pharmacokinetic properties determine the choice of drug for different clinical conditions
Absorption       - BDZs are weak bases, mainly absorbed from duodenum
                        - given orally - well & rapidly absorbed
Distribution      - most BDZs extensively protein bound (85%-95%)
                        - large volume of distribution VD - accumulation in body fat (high lipid solubility)
                        - increase lipid solubility > high rate of entry into CNS > faster onset
                        - all BDZ cross placenta
                        - detectable in breast milk > may exert depression effects on the CNS of lactating infants
Metabolism      - Metabolism: BDZs undergo extensive metabolism - Oxidation either by N-dealkylation or hydroxylation
                        - mostly by CYP3A4 or CYP2C19
                        - conjugation (glucuronides)
                        - conversion to active/inactive metabolite is an important distinction
                        - some BDZs are prodrugs & require metabolism (clorazepate)
                        - many have active metabolites with t1/2 greater than parent drug (long duration of action)
Excretion         - mostly via urine
                        - as metabolites (predominantly glucuronides)

Side effects of Benzodiazepines
Central nervous system - headache, drowsiness, excess sedation, impaired coordination, confusion, anterograde amnesia, euphoria, fatigue
Paradoxical reactions - increased anxiety, insomnia, hyperexcitability, hallucination
Gastrointestinal disturbance - nause, vomiting, diarrhea, constipation, dry mouth
Others  - BDZs have wide margin of safely if used for short periods
            - prolonged use (beyond several weeks) may cause Physical Dependence and Psychologic Dependence
            - withdrawal syndrome can occur with BDZs
            - tolerance may develop to CNS ADR and anxiolytic effect upon chronic use

Benzodiazepines Overdose & Management
Benzodiazepines is relatively safe in overdose
Acute Overdose causes -prolonged sleep
                                    -no serious respiratory depression
                                    -no coma
Fatal Overdose - incidence is low and more likely to occur when used in combination with other CNS depressants eg. alcohol, barbiturates
Management     -flumazenil which is benzodiazepines antagonist
                        -respiratory function adequately supported and monitored

Benzodiazepine Withdrawal Syndrome
High dose withrawal
-similar symptoms with alcohol withdrawal
-seizures
-delirium
-tremors
-cramps
-depression
-insomnia
-higher than therapeutic dose for more than a month

Low dose withdrawal
-symptoms different from alcohol withdrawal
-irregular heart beat
-anxiety
-weight loss
-muscle spasms
-impairment of memory & concentration
-increase blood pressure
-sensitive to light/sounds
-tinglign feeling
-feelings of unreality
-numbness
-therapeutic dose longer than 3 months
-should not be confused with symptom remergence

Benzodiazepine: Teratogenicity
Pregnancy category: D
Studies in pregnant women have demonstrated a risk to the foetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweight the potential risk
Newborn infants show withdrawal if mother used benzodiazepines
Benzodiazepines during labor can have effects on newborn
            -depressed respiration and feeding
            -floppy baby syndrome
            -low apgar scores

Benzodiazepines Drug-Drug Interaction
+ CNS depressants/alcohol > additive > increase CNS depression
+ CYP3A4 inhibitor > increase plasma [benzodiazepiens]
examples include:
azole antifungal agents (itraconazole, ketoconazole)
diltiazem
SSRIs (fluoxetine, fluvoxamine)
grapefruit juice
isoniazid
erythromycin
nefazodone
non-nucleoside reverse transcriptase inhibitors (delavirdine, efavirenz)
protease inhribitors (indinavir)
+ CYP3A4 inducer > decrease plasma [benzodiazepines]
examples include carbamazepine and rifampin
+ flumazenil = antagonism
*Combination of anxiolytic drugs should be avoided

Alprazolam (Xanax)
Pharmacokinetics        - oral administration with rapid absorbed and almost complete oral bioavailability
                        - crosses placenta & excreted in breast milk
                        - metabolisd to alfa-OH alprazolam (active) & benzophenone der. (inactive)
                        - excreted in urine (~20% unchanged)

Side effects
CNS: drowsiness, fatigue, sedation, memory impairment, cognitive disorder, somnolence, lightheadness, decreased libido, depression, confusion
CVS: hypotension, tachycardia
GI: N/V/D/C, dry mouth
Others: menstrual disorder, rash
Contraindications: patients receiving itra/ketoconazole

Drug-drug interactions
+ cimetidine, disulfiram, oral contraceptive = increase effect of alprazolam
+ theophylline = antagonize sedative effect
+ omeprazole = increase p [alprazolam]
+ imipramine, desipramine = increase p [imi/desipramine]

Diazepam (Valium)
Administration: oral, rectal, IM, IV (slow)
Pharmacokinetics          - complete oral bioavailability
                        - highly lipophilic
                        - crosses placenta & excreted in breast milk
                        - metabolised to desmethyldiazepam (active)
Side effects
CNS: confusion, dizziness, fatigue, memory impairment, disorientation, headache
CVS: hypotension, tachycardia
GI: N/V/D/C, dry mouth
others: rash, dependency/withdrawal symptoms
Contraindications: psychoses, lactation

Drug-drug interactions
+ cimetidine, disulfiram, OC = increse effect of diazepam
+ theophylline = antagonize sedative effect
+ omeprazole = increase p [diazepam]

Lorazepam
Administration: oral, IM, IV (slow)
Pharmacokinetics          - absolute bioavailability ~ 90%
                        - rapidly conjugated to lorazepam glucuronide
                        - t1/2 1-2 hour (lorazepam)
                        - t1/2 ~ 18 hours (lorazepam glucuronide)
Side effects
CNS: confusion, dizziness, fatigue, memory impairment, disorientation, headache
CVS: hypotension
GI: N/V/D/C, dry mouth, dysphagia

Drug-drug interactions
+ Oral contraceptive = increase clearance rate of lorazepam
+ theophylline = antagonize sedative effect
+ scopolamine = increase incidence of hallucinations, irrational behaviour & sedation

Clonazepam
Pharmacokinetics          - oral administration
                        - rapidly absorbed with bioavailability ~ 90%
                        - highly metabolised in liver
                        - excretion in urine (<2% unchanged drug) and into breast milk
                        - t1/2 2-11 hours

Side effects
CNS: somnolence, dizziness, disorientation, depression, memory disturbance, decreased libido
CVS: hypotension
GI: constipation, decrease appetite
Others: dysmenorrhoea

Drug-drug interactions
+ cimetidine, disulfiram, OC = increase clonazepam effect
+ CYP inducer (carbamazepine, barbiturates, phenytoin) = reduce p [clonazepam]
+ digoxin = increase p [digoxin]
+ theophylline = antagonize sedative effect

Carbamates
Meprobamate
-produce CNS depressant effects
-at multiple site (including thalamic & limbic system)
-pregnancy category: D
Pharmacokinetics          - well absorbed, 80-92 % liver metabolised
                        - excretion through urine (90%) and feces (10%)
                        - t1/2 6-14 hours
Side effects
CNS: drowsiness, ataxia, euphoria, slurred speech, dizziness, headache
CVS: palpitations, tachycardia, hypertensive crisis
GI: N/V/D
others: hypersensitivity, exacerbation of porphyria symptoms

5HT-1A Agonist
Serotonin Receptors
5-HT1A             - Anxiety, alcoholism, sexual function
5-HT1C - Anxiety, migraine pain
5-HT1D - Migraine pain
5-HT2    - Anxiety, depression, schizophrenia negative symptoms, sexual function
5-HT3    - Migraine pain, emesis, schizophrenia
5-HT4    - Anxiety, schizophrenia?
Stimulation of 5-HT1A receptors inhibit 5-HT2A, 5-HT2C, and 5-HT3 receptors

5HT1A receptor
There are 7 different types of serotonin receptor (5-HT1- 5-HT7)
The 5-HT1 receptors are classified into A, B and D subtypes, which are found in the central nervous system and blood in vessels.
Coupled to inhibitory G-proteins, the 5-HT1A receptors have an inhibitory effect on neurotransmission when bound by an agonist.

Buspirone
Buspirone is non-benzodiazepine anxiolytic which is the most selective anxiolytic currently
Mechanism of Action
-anxiety associated with altered serotonin transporters
-partial agonist at 5-HT 1A receptor presynaptic
-inhibit serotoin release
-dose not involve GABA receptors
-delayed onset (~ 1-2 week)
-pregnancy category: B
-oral administration

Advantages
-lack CNS depressant effect
-no sedation
-no impairment of performance
-no tolerance or withdrawal
-no cross-tolerance with BDZ
-no abuse/addiction potential
-minimal effect on psychomotor functions

Binding of a partial agonist to the 5-HT1A receptor causes the dissociation of inhibitory G-proteins. The G-protein alpha sub-unit binds to and inhibits adenylate cyclase. This prevents the conversion of ATP to cAMP and the initiation of other secondary messenger signaling mechanisms, hence cell depolarisation is inhibited.

Pharmacokinetics
-rapidly absorbed and undergo extensive first pass metabolism
-oxidised by CYP3A4 to active metabolite
-excretion through urine (30-60%) and feces (20-40%)
-t1/2 2-11 hours

Side effects
-dizziness, drowsiness, headache, nervousness
-tachycardia/ palpitations
-parethesia
-GI distress, N/D
-pupillary constrition (dose-dependent)

Drug-drug interactions
+fluoxetine = reduce buspirone effect
+haloperidol = increase p [haloperidol]
+CYP3A4 inducer (carbamazepine, barbiturates, phenyton) = reduce p [buspirone]
+CYP3A4 inhibitor (erythromycin, azole, protease, inh) = increase p [buspirone]
+MAOIs = risk of elevated BP

Other Agents
Antihistamines (eg. hydroxyzine, promethazine)
Monoamine oxidase inhibitors
Tricylic/tetracyclic antidepressants
Beta blockers
Natural remedies (eg. melatonin, valerian)

Drug Treatment of Anxiety
1. Generalized Anxiety Disorder
            Diazepam, lorazepam, alprazolam, buspirone
2. Phobic Anxiety
            a. simple phobia. BDZs
            b. social phobia. BDZs
3. Panic Disorders
            TCAs and MAOIs, alprazolam
4. Obsessive-Compulsive Behavior
            Clomipramine (TCA), SSRI's
5. Post-traumatic Stress Disorder
            Antidepressants, buspirone

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