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SLEEPWALKING MAY FOLLOW THE FIRST DOSE OF AMBIEN
THIS NEWSLETTER IS FOR INFORMATIONAL PURPOSES ONLY. NOTHING IN THIS CONTENT CONSTITUTES MEDICAL, PSYCHOLOGICAL, OR PROFESSIONAL ADVICE. ALWAYS CONSULT A QUALIFIED HEALTHCARE PROFESSIONAL BEFORE MAKING ANY HEALTH RELATED DECISIONS.
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THE 2019 WARNING AND THE 66 REPORTED CASES ⚠️
In 2019 The US FDA Warned Of Serious Injuries From Sleep Behaviors
Sleepwalking And Sleep Driving Were Among The Behaviors
Other Activities While Not Fully Awake Were Included Too
The FDA Called The Injuries Rare But Serious
Deaths Have Also Resulted From These Complex Sleep Behaviors
The Warning Covers Eszopiclone Zaleplon And Zolpidem
These Three Sleep Pills Are Prescription Insomnia Medicines
Complex Sleep Behaviors Appear More Common With These Three Drugs
Other Prescription Medicines Used For Sleep Were The Comparison
A Boxed Warning Was Required Which The FDA Calls Its Most Prominent
It Goes In The Prescribing Information And Medication Guides
A Contraindication Was Also Required For Past Episodes On These Drugs
That Contraindication Is Described As The Strongest Warning
A Count Of 66 Cases Covers The Past 26 Years
The Cases Resulted In Serious Injuries Including Death
Of The 66 Cases 20 Were Reported As Fatal
Forty Six Cases Reported Serious Nonfatal Injuries
Those Patients Usually Did Not Remember The Behaviors
Zolpidem Was Reported In 61 Of The 66 Cases
Eszopiclone Was Reported In 3 Cases And Zaleplon In 2
That Pattern Is Consistent With More Zolpidem Prescriptions Dispensed
Only Reports Sent To The FDA Or Found In Journals Are Counted
So There May Be Additional Cases About Which The FDA Is Unaware
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WHAT THE REPORTED CASES INVOLVED 📋
The Reported Cases Involved A Range Of Adverse Events
Falls With Serious Injuries Were Reported In 22 Cases
Those Injuries Included Intracranial Hemorrhages And Hip Fractures
The FDA Also Listed 6 Fatal Falls And 5 Accidental Overdoses
It Listed 5 Hypothermia Cases And 4 Fatal Motor Vehicle Collisions
The List Also Has 2 Carbon Monoxide Poisonings And 2 Burns
Drowning Or Near Drowning Appears In 2 Cases
The Cases Reported One Or More Episodes Of The Behaviors
They Also Reported One Or More Adverse Events Each
The Ambien Label Lists Other Complex Sleep Behaviors
Preparing And Eating Food And Making Phone Calls Are Also Reported
The Label Says Patients Can Be Seriously Injured Or Injure Others
A Louisiana Case Report Describes A 51 Year Old Woman On Zolpidem
She Had Started Zolpidem At Age 44 For Insomnia
A Few Weeks Later She Began Walking And Eating In Her Sleep
Sleep Related Eating And Sleepwalking Occurred 3 Nights Per Week
She Would Leave Her Bedroom To Go To Her Kitchen And Eat
The Next Morning She Would Have Complete Amnesia For The Event
On One Occasion She Drove Her Car 10 Miles From Her Home
Police Found Her Asleep Behind The Wheel
As A Preventive Measure She Installed Alarms On Her Doors
Her Zolpidem Was Gradually Withdrawn After Her Evaluation
Sleep Activities Ceased And Did Not Recur In 6 Months Of Follow Up
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WHO SHOULD NOT TAKE THESE DRUGS 🛏️
The FDA Says Not To Prescribe These Drugs After A Past Episode
A Past Episode Means Complex Sleep Behaviors On Any Of The Three
The Ambien Label Lists A Contraindication After Episodes On Ambien
Patients Should Stop Their Medicine After An Episode Says The FDA
This Applies Even If The Episode Caused No Serious Injury
The Label Says To Stop Ambien Immediately After An Episode
Patients With And Without A History Of These Behaviors Were Injured
The Injuries Occurred Even At The Lowest Recommended Doses
Episodes Can Occur After Just One Dose
Complex Sleep Behaviors May Follow The First Or Any Later Ambien Use
They Can Also Occur After A Longer Duration Of Treatment
Starting With The Lowest Possible Dose Is Advised By The FDA
The FDA Tells Prescribers To Remind Patients Not To Mix In Alcohol
Behaviors Can Occur With Or Without Alcohol After Taking The Drugs
Lunesta And Ambien Users Are Told To Go To Bed Right After Dosing
The FDA Tells Them To Stay In Bed For 7 To 8 Hours
Users Of Sonata Or Intermezzo Are Told To Take The Medicine In Bed
The FDA Advises Them To Remain There For At Least 4 Hours
Although Rare The Behaviors Have Led To Serious Injuries Or Death
