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OUT MY BACK DOOR AMBIEN AND DRIVING WHAT IS ALLTHE CLAMOR ABOUT John J. Treuting, Ph.D. CAT Winter Meeting February 5, 2008 Redondo Beach, CA PARACELSUS SAID “ALL SUBSTANCES ARE POISONS; THERE IS NONE WHICH IS NOT A POISON. THE RIGHT DOSE DIFFERENTIATES A POISON FROM A REMEDY.” TEXAS CHILI COOK-OFF CHILI #1 MIKE’ MIKE’S MANIAC MOBSTER MONSTER CHILI JUDGE #1-- LITTLE TOO HEAVY ON THE TOMATO. AMUSING KICK JUDGE #2—NICE, SMOOTH TOMATO FLAVOR. VERY MILD TEXAS CHILI COOK-OFF TEXAS CHILI COOK-OFF CHILI #1 MIKE’ MIKE’S MANIAC MOBSTER MONSTER CHILI CHILI #2 ARTHUR’ ARTHUR’S AFTERBURNER CHILI JUDGE #3 (FRANK)—HOLY CRAP, WHAT THE HELL IS THIS STUFF? YOU COULD REMOVE DRIED PAINT FROM YOUR DRIVEWAY. TOOK ME TWO BEER TO PUT THE FLAMES OUT. I HOPE THAT’S THE WORST ONE. THESE TEXANS ARE CRAZY. JUDGE #--SMOKY, WITH A HINT OF PORK. SLIGHT JALAPENO TANG. JUDGE #2—EXCITING BBQ FLAVOR, NEEDS MORE PEPPERS TO BE TAKEN SERIOUSLY. TEXAS CHILI COOK-OFF TEXAS CHILI COOK-OFF CHILI #2 ARTHUR’ ARTHUR’S AFTERBURNER CHILI CHILI #3 FRED’ FRED’S FAMOUS BURN DOWN THE BARN CHILI JUDGE #3 (FRANK)—KEEP THIS OUT OF THE REACH OF CHILDREN. I’M NOT SURE WHAT I’M SUPPOSED TO TASTE BESIDE PAIN. I HAD TO WAVE OFF TWO PEOPLE WHO WANTED TO GIVE ME THE HEIMLICH MANEUVER. THEY HAD TO RUSH IN MORE BEER WHEN THY SAW THE LOOK ON MY FACE. JUDGE #1--EXCELLENT FIREHOUSE CHILI. GREAT KICK. NEEDS MORE BEANS JUDGE #2—A BEAN LESS CHILI, A BIT SALTY, GOOD USE OF PEPPERS. TEXAS CHILI COOK-OFF TEXAS CHILI COOK-OFF CHILI #3 FRED’ FRED’S FAMOUS BURN DOWN THE BARN CHILI CHILI #4 BUBBA’ BUBBA’S BLACK MAGIC JUDGE #3(FRANK)—CALL THE EPA. I’VE LOCATED A URANIUM SPILL. MY NOSE FEELS LIKE I HAVE BEEN SNORTING DRANO.EVERYONE KNOW THE ROUTINE BY NOW. GET ME MORE BEER BEFORE I IGNITE! BARMAID POUNDED ME ON THE BACK, NOW MY BACKBONE IS IN THE FRONT OF MY CHEST. I’M GETTING SHITFACED FROM ALL OF THE BEER. JUDGE #1-- BLACK BEAN CHILI WITH ALMOST NO SPICE. DISAPPOINTING. JUDGE#2—HINT OF LIME IN THE BLACK BEANS. GOOD SIDE DISH FOR FISH OR OTHER MILD FOODS, NOT MUCH OF A CHILI. TEXAS CHILI COOK-OFF TEXAS CHILI COOK-OFF CHILI #4 BUBBA’ BUBBA’S BLACK MAGIC CHILI #5 LINDA’ LINDA’S LEGAL LIP REMOVAL JUDGE #3 (FRANK)—I FELT SOMETHING SCRAPING ACROSS MY TONGUE, BUT WAS UNABLE TO TASTE IT. IS IT POSSIBLE TO BURN OUT TASTE BUDS? SALLY, THE BARMAID, WAS STANDING BEHIND ME WITH FRESH REFILLS. THAT 300 POUND WOMAN IS STARTING TO LOOK HOT, JUST LIKE THIS NUCLEAR WASTE I’M EATING! IS CHILI AN APHRODISIAC? JUDGE #1--MEATY, STRONG CHILI. CAYENNE PEPPERS FRESHLY GROUND, ADDING CONSIDERABLE KICK. VERY IMPRESSIVE. JUDGE #2—CHILI USING SHREDDED BEEF, COULD USE MORE TOMATO. MUST ADMIT THE CAYENNE PEPPERS MAKE A STRONG STATEMENT. TEXAS CHILI COOK-OFF TEXAS CHILI COOK-OFF CHILI #5 LINDA’ LINDA’S LEGAL LIP REMOVAL CHILI #7 SUSAN’ SUSAN’S SCREAMING SENSATION CHILI JUDGE #3 (FRANK)— (FRANK)—MY EARS ARE RINGING, SWEAT IS POURING OFF MY FOREHEAD AND I CAN NO LONGER FOCUS MY EYES. I FARTED AND FOUR PEOPLE BEHIND ME NEEDED PARAMEDICS. THE CONTESTANT SEEM OFFENDED WHEN I TOLD HER THAT HER CHILI HAD GIVEN ME BRAIN DAMAGE. SALLY SAVED MY TONGUE FROM BLEEDING BY POURING BEER DIRECTLY ON IT FROM THE PITCHER. I WONDER IF I’I’M BURNING MY LIPS OFF. JUDGE #1-A MEDIOCRE CHILI WITH TOO MUCH #1--A RELIANCE ON CANNED PEPPERS. JUDGE #2— #2—HO HUM, TASTES AS IF THE CHEF LITERALLY THREW IN A CAN OF CHILI PEPPERS AT THE LAST MOMENT. I SHOULD NOTE THAT I AM WORRIED ABOUT JUDGE #3. HE APPEARS TO BE IN A BIT OF DISTRESS AS HE IS CURSING UNCONTROLLABLY. TEXAS CHILI COOK-OFF TEXAS CHILI COOK-OFF CHILI #7 SUSAN’ SUSAN’S SCREAMING SENSATION CHILI CHILI #7 SUSAN’ SUSAN’S SCREAMING SENSATION CHILI JUDGE #3(FRANK)—YOU COULD PUT A GRENADE IN MY MOUTH, PULL THE PIN, AND I WOULDN’T FEEL A THEIN. I’VE LOST SIGHT IN ONE EYE, AND THE WORLD SOUNDS LIKE IT IS MADE OF RUSHING WATER. MY SHIRT IS COVERED WITH CHILI, WHICH SLID UNNOTICED OUT OF MY MOUTH. MY PANTS ARE FULL OF LAVA-LIKE CRAP TO MATCH MY SHIRT. AT LEAST DURING THE AUTOPSY, THEY’LL KNOW WHAT KILLED ME. I’VE DECIDED TO STOP BREATHING, IT’S TOO PAINFUL. SCREW IT; I’M NOT GETTING ANY OXYGEN ANYWAY. IF I NEED AIR, I’LL JUST SUCK IT IN THROUGH THE 4-INCH HOLE IN MY STOMACH. AMBIEN AND DRIVING TEXAS CHILI COOK-OFF CHILI #8 TOMMY’ TOMMY’S TOETOE-NAIL CURLING CHILI WHAT IS ALLTHE CLAMOR ABOUT JUDGE #1-#1-- THE PERFECT ENDING, THIS IS A NICE BLEND CHILI. NOT TOO BOLD, BUT SPICY ENOUGH TO DECLARE IT’ IT’S EXISTENCE. John J. Treuting, Ph.D. JUDGE #2– #2– THIS FINAL ENTRY IS A GOOD, BALANCED CHILI. NEITHER MILD NOR HOT. SORRY TO SEE THAT MOST OF IT WAS LOST WHEN JUDGE #3 PASSED OUT, FELL OVER AND PULLED THE CHILI POT DOWN ON TOP OF HIMSELF. POOR DUD, WONDER HOW HE’ HE’D HAVE REACTED TO REALLY HOT CHILI. CAT Winter Meeting February 5, 2008 Redondo Beach, CA NEWS FLASHES ABOUT AMBIEN AMBIEN SUCCESS “POPULAR SLEEP AID COULD CAUSE LITTLE KNOWN SIDE EFFECTS” ‘SLEEPDRIVING’ WREAKING HAVOC ON ROADS “DRIVING, OTHER ERATIC BEHAVIORS REPORTED AFTER TAKING ZOLPIDEM” MOST POPULAR INSOMNIA MEDICATION IN THE USA MANUFACTURED BY FRENCH FIRM SANOFI-AVENTUS MORE THAN 26 MILLION RX SOLD LAST YEAR CHEMICAL STRUCTURE OF AMBIEN INDICATIONS FOR USE ZOLPIDEM IS USED IN THE TREATMENT OF INSOMNIA CHARACTEREIZED BY DIFFICULTIES WITH SLEEP ONSET AND/OR SLEEP MAINTENANCE DOSAGE FORMS AND STRENGTHS TABLET, AS TARTRATE 5MG, 10 MG CR TABLETS(EXTENDED RELEASE) 6.25 MG (PINK) 12.5 MG (BLUE) DOSAGE & ADMINISTRATION THE RECOMMENDED DOSE FOR AMBIEN CR IS 12.5 MG ONCE DAILY IMMEDIATELY BEFORE BEDTIME AND SHOULD NOT EXCEED 12.5 MG PER DAY Pharmacokinetics and Pharmacodynamics MECHANISM OF ACTION (PHARMACODYNAMICS) Dose of drug administered ABSORPTION Drug concentration in systemic circulation DISTRIBUTION Drug in tissues of distribution PHARMACOKINETICS ELIMINATION Drug metabolized or excreted Drug concentration at site of action Pharmacologic Effect PHARMACODYNAMICS GABA A receptor agonist Binds to receptors containing an a1 subunit shortens sleep latency and prolongs total sleep time Clinical response Toxicity Efficacy PHARMACOKINETIC PROFILE OF AMBIEN RAPID ABSORPTION FROM THE GI TRACT SHORT ELIMINATION HALF-LIFE (T ½ ) OF 2.2 HOURS IN HEALTHY SUBJECTS NO ACTIVE METABOLITES CLINICAL TRIALS BLOOD CONCENTRATIONS SINGLE DOSES (PEAK) 5MG 10 MG 15 MG 20 MG 60 NG/ML @ 1.6 HRS 120 NG/ML @ 1.6 HRS 200 NG/ML @ 1.5 HRS 230 NG/ML @ 2.1 HRS THERAPEUTIC RANGE: < 250 NG/ML COMMON SIDE EFFECTS DROWSINESS EFFECTS ON DRIVING (CNS DEPRESSANT) IMPAIRED COORDINATION IMPAIRED REACTION TIME IMPAIRED COGNITIVE SKILLS DIZZINESS LIGHTHEADEDNESS DIFFICULTY WITH COORDINATION DRUG RECOGNITION EVALUATION HGN PRESENT VGN PRESENT (HIGH DOSES) LOC PRESENT PUPIL SIZE NORMAL PULSE DOWN BLOOD PRESSURE DOWN BODY TEMPERATURE NORMAL METHODS OF ANALYSIS ELISA GAS CHROMATOGRAPHY LITERATURE CITATIONS LITERATURE CITATIONS LIDDICOAT, L. AAFS, 2006 DISCUSSED 6 CASES OF IMPAIRED DRIVING RELATED TO ZOLPIDEM LEVELS RANGED FROM 190-4440 NG/ML.SOME CASES HAD OTHER DRUGS DETECTED LOGAN, B. J. FOR. SCI. (46) 1, 2001 FIVE CASES ONLY ZOLPIDEM DETECTED (80-1400 NG/ML) SIGNS OF IMPAIRMENT –SLOW AND SLURRED SPEECH, SLOW REFLEXES, DISORIENTATION, LACK OF BALANCE AND “BLACKING OUT” SPECIAL CONCERNS FROM AMBIEN PACKAGE INSERT SPECIAL CONCERNS “SLEEP DRIVING .“ THERE HAVE BEEN REPORTS OF PEOPLE GETTING OUR OF BED AFTER TAKING A SLEEP MEDICINE AND DRIVING THEIR CARS WHILE NOT FULLY AWAKE, OFTEN WITH NO MEMORY OF THE EVENT MEMORY LOSS-AMNESIA SLEEPWALKING-SOMNANBULISM SLEEPWALKERS ARE CAPABLE OF PERFORMING A VARIETY OF ACTIVITIES FROM SIMPLY GETTING UP AND WALKING AROUND THE ROOM TO DRIVING A CAR AND PLAYING AN INSTRUMENT CHARACTERISTICS OF SLEEPINGWALKING YOU LEAVE YOUR BED WHILE SLEEPING, USUALLY IN THE FIRST THIRD OF YOUR SLEEP PATTERN OTHERS FIND IT DIFFICULT TO WAKE YOU DURING AN EPISODE OF SLEEPWALKING YOU CAN’ CAN’T REMEMBER WHAT HAPPENED WHILE YOU WERE SLEEPWALKING CHARACTERISTICS OF SLEEPINGWALKING WHEN YOU DO WAKE UP FROM AN EPISODE, YOU’ YOU’RE CONFUSED YOU AREN’ AREN’T SUFFERING FROM DEMENTIA OR ANOTHER PHYSICAL DISORDER IT IMPAIRS YOUR WORK OR SOCIAL LIFE SOURCE: DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL DISORDERS (DSM(DSM-IV) Stages of Sleep AMBIEN CLASS ACTION SUIT 2006 PLAINTIFF JUDITH RENEE LASSWELL LT IN US NAVY WITH 17 YR. SERVICE PRESCRIBED 10 MG AMBIEN IN 2/05 FOR INSOMNIA LASSWELL ALWAYS TOOK IT AT NIGHT AS SHE WAS GETTING READY TO GO TO BED TAKES AMBIEN AT 7 PM, WENT TO SLEEP AND ABOUT 9PM ENTERS INTO SOMNAMBULISM AMBIEN CLASS ACTION SUIT 2006 PLAINTIFF DRESSED HERSELF, WALKED TO INTELLIGENCE CENTER IN A STUMBLING ALMOST DRIMLEM STATE AMD STARTED TALKING NONSENSE WITH COCO-WORKERS. THEY WALK HER BACK TO HER BARACKS, PUT HER BACK INTO BED AND TOLD HER ABOUT THE INCIDENT THE NEXT DAY. PLAINTIFF HAD NO MEMORY OF THIS INCIDENT. AMBIEN CLASS ACTION SUIT 2006 PLAINTIFF BROTHERS WORKED AS A FINANCIAL ANALYST WHILE STUDYING FOR HER CPA PRESCRIBED 10 MG AMBIEN FOR TRANSIENT INSOMNIA IN MAY OF 2005 ON 3RD DAY SHE TOOK THE AMBIEN AROUND 1:57 AM AFTER RETIRING TO BED THE NEXT THING SHE RECALL IS WAKING UP ON THE CONCRETE FLOOR OF A JAIL CELL AMBIEN CLASS ACTION SUIT 2006 ON SEPT 3, 2006 PLAINTIFF WAS ARRESTED BY HER BASE POLICE FOR SHOPLIFTING A DVD AND A CANDLE AT THE BASE EXCHANGE. CHARGES WERE LEVIED UPON PLAINTIFF FOR OFFOFF-BASE SHOPLIFTING WHERE SHE DROVE TO A MARSHALLS AND OTHER STORES IN THE AREA. SHE HAS NO RECALL OF THESE EVENTS. AMBIEN CLASS ACTION SUIT 2006 SHE DISCOVERED LATER FROM THE POLICE REPORT THAT SHE GOT OUT OF BED AROUND 6AM, LEFT HER HOUSE, DROVE HER MOTHER’ MOTHER’S CAR INTO A PARKED WEHICLE AND LEFT THAT SCENE. SHE RANINTO ANOTHER VEHICL, LEFT THE SCENE AND RETURNED HOME AS IF NOTHING HAPPENED, HAD A CONVERSATION WITH HER MOTHER AND WAS ARRESTED IN HER BEDROOM THAT MORNING PLAINTIFF HAS NO MEMORY OF THE EVENTS THAT NIGHT AND INTO THE MORNING LEADING TO HER ARREST. PERSONAL CASE REVIEW 27 YEAR OLD WHITE FEMALE NURSE WHO WORKED NIGHT SHIFT AFTER WORK AT HOME, WATCHED TV(SEVERAL MOVIES), DRANK BEER (5(5-6 ) TOOK 12.6 AMBIEN CR AROUND 55-6AM AND WENT TO BED. NOTE. ALSO TOOK A WELLBUTRIN NEXT THING SHE REMEMBERS IS BEING IN A POLICE CAR AND TOLD SHE WAS BEING TAKEN FOR BLOOD DRAW. SHE WAS IN HER NIGHTGOWN AND WAS BAREFOOK. SHE WAS STOPPED FOR SWEARING HER VEHCILE ON THE FREEWAY SO, WHERE ARE WE FACTORS NOT GOING TO BED RIGHT AFTER TAKING AMBIEN ATTEMPTING TO DRIVE TO SOON TAKING TOO MUCH INGESTING WITH OTHER DRUGS PERSONAL CASE REVIEW BLOOD ANALYSIS REPORT NOTED DETECTION OF BUPROPION METABOLITE AND ZOLPIDEM AT 78 NG/ML. HER BAC WAS 0.19 % ARRESTING OFFICER STATED HER EYES WERE HALF OPEN AND SHE HAD A BLANK STARE ON HER FACE SO, WHERE ARE WE HOWEVER THERE ARE CASES WHERE PEOPLE GOT OUT OF BED IN NIGHT CLOTHES, ONLY AMBIEN DETECTED AND WERE SLEEPDRIVING THANK YOU. ARE THERE ANY QUESTIONS?