ZIMOVANE AT-HOME WITHDRAWAL AND TAPERING PROGRAM

Zimovane is a nonbenzodiazepine hypnotic agent used in the treatment of insomnia and is recommended for short-term use only (7 consecutive days). Z drugs were initially thought to be less addictive but time has shown a high risk of dependence and withdrawal symptoms. Initially Zimovane was marketed as a safer alternative to benzodiazepines but a meta analysis (quantitative statistical analysis) found there are few clear and consistent differences between Zimovane and benzodiazepines in terms of sleep onset, sleep duration, number of awakenings, quality of sleep, adverse events, tolerance, rebound insomnia and daytime alertness. More common reactions to Zimovane show a reduction in total time spent in REM sleep. 

Zimovane has shown it may have a greater addictive potential than Benzodiazepines and has been described as a "benzodiazepine in disguise". Tolerance to the effects of Zimovane can develop after a few weeks and abrupt withdrawal (particularly after prolonged use) can cause seizures and delirium. Due to the high dependence risk and effect on the GABA receptor, a gradual taper is recommended. 

Zimovane can cause horrible withdrawal symptoms that include a worsening of sleep and anxiety. It is critical to stop this drug properly and that is why our nonprofit was formed nearly 12 years ago. We know the importance of a slow-taper to allow the GABA receptors time to readjust at each reduction, but more importantly is getting the GABA receptors back to a healthy state so true sleep returns. Our program addresses each component of Zimovane withdrawal - correct taper rates; all-natural items to ease symptoms; removing any interaction items through vitamins, over-the-counter, herbs, etc that actually increase symptoms and augmenting true healing.

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ZIMOVANE WITHDRAWAL SYMPTOMS MAY INCLUDE:

abdominal pains, aching, agoraphobia, anxiety, blurred vision, body vibrations, changes in perception, diarrhea, distended abdomen, feeling of unreality, flu-like symptoms, flatulence, food cravings, hair loss, heart palpitations, heavy limbs, increased allergies, increased sense of smell, insomnia, lethargy, loss of balance, metallic taste, muscle spasms, nightmares, panic attacks, paranoia, persistent & unpleasant memories, severe headaches, shaking, short term memory loss, sore mouth and tongue, sound & light sensitivity, speech difficulties, sweating, suicidal thoughts, tinnitus, unusually sensitive, fear

ZIMOVANE ABRUPT DISCONTINUATION SYMPTOMS MAY INCLUDE:

abdominal & muscle cramps, vomiting, sweating, shakiness, & rarely, seizures may occur & finally rebound insomnia 

ZIMOVANE SIDE EFFECTS MAY INCLUDE: 

drowsiness, dizziness, lightheadedness, difficulty with coordination, memory loss or amnesia, tolerance, dependence, changes in behavior and thinking; such as more outgoing or aggressive behavior than normal, confusion, strange behavior, agitation, hallucinations, worsening of depression, suicidal thoughts

ZIMOVANE ADVERSE REACTIONS MAY INCLUDE: per PDR  

Severe: bronchospasm, oliguria, erythema multiforme, peptic ulce, suicidal ideation, angioedem, anaphylactoid reactions 

Moderate: depression, confusion, hallucinations, memory impairment, myasthenia, oral ulceration, urinary incontinence, ataxia, vaginitis, melena, hypertonia, conjunctivitis, dysuria, cholelithiasis, hematuria, hypertension, lymphadenopathy, nystagmus, stomatitis, heat intolerance, anemia, hostility, cystitis, contact dermatitis, hypercholesterolemia, vaginal bleeding, peripheral neuropathy, euphoria, gastritis, hyperlipidemia, hypokalemia, myopathy, hepatomegaly, neuritis, photophobia, colitis, hepatitis, hyperesthesia, iritis, dehydration, phlebitis, hyperacusis, gout, dysphagia, furunculosis, migraine, chest pain (unspecified), peripheral edema, impaired cognition, dyspnea, complex sleep-related behaviors 

Mild: dysgeusia, headache, drowsiness, infection, dizziness, xerostomia, dyspepsia, restlessness, nausea, diarrhea, rash, anxiety, abnormal dreams, vomiting, gynecomastia, dysmenorrhea, libido decrease, increased urinary frequency, fever, laryngitis, insomnia, xerophthalmia, hiccups, amenorrhea, tinnitus, xerosis, epistaxis, vertigo, anorexia, otalgia, skin discoloration, diaphoresis, malaise, weight loss, urticaria, halitosis, acne vulgaris, emotional lability, breast enlargement , muscle cramps, appetite stimulation, alopecia, photosensitivity, weight gain, paresthesias, polydipsia, agitation, menorrhagia, hirsutism, mydriasis, ptosis, tremor, maculopapular rash, dysosmia, somnambulism

ZIMOVANE BOXED WARNINGS:  per PDR

Behavioral changes, CNS depression, coadministration with other CNS depressants, complex sleep-related behaviors, driving or operating machinery, drug-induced complex sleep-related behaviors, ethanol ingestion

Sedative-hypnotics can cause complex sleep-related behaviors such as phone calls, sexual activity, preparing and eating food, or sleep driving while not fully awake and in some cases having no memory of the event. These behaviors appear to be more frequent with nonbenzodiazepine benzodiazepine-receptor agonists (NBRAs), such as eszopiclone, than other sedative-hypnotics. Although rare, serious injuries or death have occurred; therefore, eszopiclone and other NBRAs are contraindicated in patients with a history of drug-induced complex sleep-related behaviors. Patients should be informed of the risks before receiving any medication from this class, including instructions to discontinue the medication if they experience a sleep-related episode and to contact their healthcare provider immediately. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of NBRAs to the FDA MedWatch Safety Information and Adverse Event Reporting Program.[64083] Because eszopiclone has a rapid onset of action and causes CNS depression, it should only be administered before retiring. Patients should be instructed to avoid driving or operating machinery or performing other tasks requiring mental alertness after taking eszopiclone. Because eszopiclone can cause drowsiness and a decreased level of consciousness, there is a higher risk of falls, particularly in the elderly, with the potential for subsequent severe injuries. A variety of abnormal thinking and behavioral changes have been reported to occur in association with the use of sedative/hypnotics. Some of these changes may be characterized by decreased inhibition (e.g., aggressiveness and extroversion that seem out of character), similar to effects produced by alcohol and other CNS depressants. Other reported behavioral changes have included bizarre behavior, agitation, hallucinations, and depersonalization. Amnesia and other neuropsychiatric symptoms may occur unpredictably. Any emergence of changes in thinking or behavior should be evaluated. Although such behaviors may occur with the use of the drug alone at therapeutic doses, the use of higher doses, or the use of the drug with alcohol or the coadministration with other CNS depressants appears to increase the risks. Advise patients to avoid ethanol ingestion. Eszopiclone can cause next-day psychomotor and memory impairment, with patients often unaware that they are impaired. Results from one study indicate that peak impairment after a 3 mg dose occurs 7.5 hours later, with clinically relevant effects still present at 11.5 hours after the dose. Lower initial dosages of eszopiclone should be considered in patients taking other CNS depressant therapies. 

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According to the FDA:

Withdrawal Effects

Following rapid dose decrease or abrupt discontinuation of the use of sedative/hypnotics, there have been reports of signs and symptoms similar to those associated with withdrawal from other CNS-depressant drugs [see Drug Abuse and Dependence (9)].

Withdrawal Effects: symptoms may occur with rapid dose reduction or discontinuation 

REFERENCES:

https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021476s030lbl.pdf

FDA warns next day impairment sleep aid lunesta eszopiclone

FDA requires stronger warnings about rare serious incidents related certain prescription insomnia

https://www.tandfonline.com/doi/pdf/10.1080/08998280.2006.11928127

https://www.ajemjournal.com/article/S0735-6757(06)00049-0/abstract 

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