ZOLPIDEM

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ZOLPIDEM

  • [AMBIEN]
  • [IVADAL]
  • [STILNOCT]
  • [STILNOX]

DEA CODE 2783: Schedule 4

About Zolpidem:

  • Zolpidem is a sleeping pill
  • It's used to treat insomnia (when you might have trouble getting to sleep and staying asleep). It helps you fall asleep more quickly and makes you less likely to wake up during the night.
  • Zolpidem comes as tablets. It's only available on prescription.

Key Facts:

  • Zolpidem takes around 1 hour to work
  • You'll usually take it for just a few weeks (up to 4 weeks)
  • Common side effects are a metallic taste in your mouth or a dry mouth, and feeling sleepy in the daytime
  • Do not drink alcohol or caffeine while you're on zolpidem
  • Zolpidem is also called by the brand name Stilnoct
  • Zolpidem can be taken by most adults aged 18 and over.
  • Zolpidem tablets come in 2 different strengths - 5mg and 10mg.

Zolpidem Tablet, Sublingual (Edluar):
Zolpidem is used to treat a certain sleep problem (insomnia). If you have trouble falling asleep, it helps you fall asleep faster, so you can get a better night's rest. Zolpidem belongs to a class of drugs called sedative-hypnotics. It acts on your brain to produce a calming effect. Used for:

Difficulty falling asleep

Insomnia with middle of the night awakening and 4 hours sleep time remaining

Use of this medication is usually limited to short treatment periods of 1 to 2 weeks or less. If your insomnia continues for a longer time, talk to your doctor to see if you need other treatment.

Before Using:
Tell your doctor or pharmacist your medical history, especially of:

  • kidney disease
  • liver disease
  • lung/breathing problems (such as chronic obstructive pulmonary disease-COPD
  • sleep apnea)
  • mental/mood problems (such as depression
  • thoughts of suicide)
  • personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol)
  • personal or family history of sleepwalking
  • a certain muscle disease (myasthenia gravis)

Precautions:

  • The effects of this drug can last even after you wake up the next day.
  • If you did not get 7 to 8 hours of sleep or took other medications that made you sleepy or are more sensitive to this drug, you may feel alert but not think clearly enough to drive
  • You may also experience dizziness or blurred/double vision.
  • Alcohol or marijuana (cannabis) can make you more dizzy.
  • Wait at least 8 hours after taking this drug before driving, and do not drive, use machinery, or do anything that needs alertness until you can do it safely
  • This medication may also increase the risk of falls
  • Avoid alcoholic beverages.
  • Talk to your doctor if you are using marijuana (cannabis)

User Reviews:

17 Total User Reviews
Zolpidem Sublingual Read Reviews
Condition: Difficulty Falling Asleep (13 Reviews):
Effectiveness(3.77)

Ease of Use(4.38)

Satisfaction(2.85)

Zolpidem drug usage

50th most prescribed medicine in the United States for 2017

Pediatric:
Use of zolpidem is not recommended in children. Safety and efficacy have not been established.

Geriatric:
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of zolpidem in the elderly. However, elderly patients are more sensitive to the effects of this medicine (eg, confusion, dizziness, and falling) than younger adults.

Breastfeeding:

Summary of Use during Lactation:
Because of the low levels of zolpidem in breastmilk and its short half-life, amounts ingested by the infant are small and would not be expected to cause any adverse effects in breastfed infants. Monitor infants for excess sedation, hypotonia, and respiratory depression.

Drug Levels:
Maternal Levels. Five nursing mothers who were 3 to 4 days postpartum were given a single oral dose of zolpidem 20 mg. Milk collected 3 hours after the dose contained between 0.76 and 3.88 mcg of zolpidem. This corresponded to 0.004 to 0.019% of the maternal dosage. The drug was undetectable (<0.5 mcg/L) in milk 13 and 16 hours after the dose.

Alternate Drugs to Consider:

Important Information:

Zolpidem may cause a severe allergic reaction. Stop taking zolpidem and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Do not share this medication with another person, even if they have the same symptoms you have. The recommended doses of zolpidem are not the same in men and women, and this drug is not approved for use in children. Misuse of this medication can result in dangerous side effects. Zolpidem may impair your thinking or reactions. You may still feel sleepy the morning after taking this medicine, especially if you take the extended-release tablet, or if you are a woman. Wait at least 4 hours or until you are fully awake before you do anything that requires you to be awake and alert.

Never take this medicine in larger amounts or for longer than prescribed.

Do not take zolpidem if you have consumed alcohol during the day or just before bed.

Avoid taking zolpidem during travel, such as to sleep on an airplane. You may be awakened before the effects of the medicine have worn off. Amnesia (forgetfulness) is more common if you do not get a full 7 to 8 hours of sleep after taking this medicine.

Avoid driving or hazardous activity until you know how zolpidem will affect you. You may still feel sleepy in the morning, and your reactions could be impaired. Wait until you are fully awake before you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert.

Do not take this medicine if you have consumed alcohol during the day or just before bed.

Interactions:

Drug Interactions (396) Alcohol/Food Interactions (1) Disease Interactions (8)


What other drugs will affect zolpidem?
Using zolpidem with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures. Many drugs can interact with zolpidem, making it less effective or increasing side effects. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

A total of 396 drugs are known to interact with zolpidem.

  • 25 major drug interactions
  • 368 moderate drug interactions
  • 3 minor drug interactions

Zolpidem is usually used for the treatment of insomnia as a hypnotic drug. It was also suggested to be effective in the treatment of dystonia in some studies. Zolpidem can be one of useful alternative pharmacological treatments for blepharospasm. Zolpidem interacts with a GABA-BZ receptor complex and shares some of the pharmacological properties of the benzodiazepines. In contrast to the benzodiazepines, which non-selectively bind to and activate all BZ receptor subtypes, zolpidem in vitro binds the BZ1 receptor preferentially with a high affinity ratio of the a1/a5 subunits. This selective binding of zolpidem on the BZ1 receptor is not absolute, but it may explain the relative absence of myorelaxant and anticonvulsant effects in animal studies as well as the preservation of deep sleep in human studies of zolpidem tartrate at hypnotic doses.

Liver:
Zolpidem has rarely been implicated in causing serum enzyme elevations and has not been reported to cause clinically apparent liver injury.

Zolpidem Hepatotoxicity:
In multiple premarketing randomized controlled trials, zolpidem was not associated with an increased rate of serum enzyme elevations in comparison to placebo therapy. A single instance of clinically apparent liver injury has been reported. The onset of injury was 2 days after a single dose of zolpidem and was accompanied by abdominal pain, but no jaundice. The pattern of liver enzyme elevations was hepatocellular and the abnormalities were self-limited, although they seemed to recur on reexposure. Zolpidem is metabolized in the liver by the cytochrome P450 system (predominantly CYP 3A4) and can cause drug-drug interactions, although such interactions are rare. Thus, zolpidem has not been linked to cases of liver injury with jaundice, but rarely may cause transient, mild-to-moderate serum enzyme elevations with or without symptoms.

E Likelihood score: E (unlikely cause of clinically apparent liver injury).



Zolpidem
Duration:

Commonly prescribed for insomnia, Ambien (zolpidem) can cause realistic hallucinations similar to those of deliriants, and is very likely to cause amnesia at higher doses. Take care when using this drug, as it tends to lower inhibitions to a level which causes the user to do things they might not normally do when sober.

RouteOnsetDurationAfter Effects
Tripsit Factsheets
All ROAs:15-45 minutes5-10 hours1-24 hours
Zolpidem Duration
Effects:
Helps with insomnia/sleep, hallucinations through all physical senses, increased or decreased libido, delusions
Avoid:
All other CNS depressants

Ambien (zolpidem tartrate)
Side Effects:
  • RxList
  • Zolpidem may cause a severe allergic reaction. Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; nausea and vomiting; swelling of your face, lips, tongue, or throat.
    Some people using this medicine have engaged in activity while not fully awake and later had no memory of it. This may include walking, driving, or making phone calls. If this happens to you, stop taking zolpidem and call your doctor right away.
    Serious injury or death could occur if you walk or drive while you are not fully awake.
    Call your doctor at once if you have:
    • anxiety, depression, aggression, agitation
    • confusion, hallucinations (hearing or seeing things)
    • memory problems, unusual thoughts or behavior
    • thoughts of hurting yourself
    • feeling like you might pass out
    Common side effects may include:
    • daytime drowsiness, dizziness, feeling "drugged" or light-headed
    • headache
    • diarrhea
    • feeling tired
    This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Ambien (zolpidem tartrate)
    Maximum Dosage:
    Prescribers Digital Reference
    Adults:Immediate-release tablets (i.e., Ambien): 10 mg/day PO.
    Lingual spray (i.e., Zolpimist): 10 mg/day PO.
    Orally disintegrating tablets (i.e., Tovalt ODT): 10 mg/day PO.
    Extended-release tablets (i.e., Ambien CR): 12.5 mg/day PO.
    Sublingual tablets (i.e. Edluar): 10 mg/day SL.
    Sublingual tablets (i.e., Intermezzo): 1.75 mg SL once per night in women and 3.5 mg SL once per night in men.
    Geriatric:Immediate-release tablets (i.e., Ambien): The recommended geriatric dose is 5 mg/day PO.
    Lingual spray (i.e., Zolpimist): The recommended geriatric dose is 5 mg/day PO.
    Extended-release tablets (i.e., Ambien CR): The recommended geriatric dose is 6.25 mg/day PO.
    Sublingual tablets (i.e. Edluar): The recommended geriatric dose is 5 mg/day SL.
    Sublingual tablets (i.e., Intermezzo): The recommended geriatric dose is 1.75 mg SL once per night as needed.
    Adolescents:Safety and efficacy have not been established.
    Children:Safety and efficacy have not been established.
    Infants:Safety and efficacy have not been established.
    Neonates:Safety and efficacy have not been established.

    Ambien, Ambien CR (zolpidem) (Rx)
    Black Box Warnings:

    Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur; some of these events may result in serious injuries, including death

    Discontinue therapy immediately if a patient experiences complex sleep behavior

      
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