How does Lunata, Zolpidem work?
Lunata tablets contain the active ingredient Zolpidem, which is a type of medicine called a non-benzodiazepine hypnotic. It acts in the brain to aid sleep.
Zolpidem works by acting on receptors in the brain called GABA receptors, specifically the GABA-A receptors. This causes the release of a neurotransmitter called GABA in the brain.
GABA is a neurotransmitter that acts as a natural ‘nerve-calming’ agent. It helps keep the nerve activity in the brain in balance, and is involved in inducing sleepiness, reducing anxiety and relaxing muscles.
Zolpidem can be used as a short-term treatment for insomnia. This includes difficulty falling asleep, waking in the night, waking early in the morning and sleeping problems that are causing severe distress.
Zolpidem decreases the time taken to fall asleep and night-time awakenings, as well as increasing the total amount of time spent sleeping. However, it is only suitable for short-term treatment of insomnia (up to four weeks), as when used for longer periods it has a potential for dependence and addiction.
The medicine should be taken just before going to bed at night, or in bed.
What is Zolpidem used for?
• Short-term treatment of insomnia.
What is Lunata?
Lunatais a sedative, also called a hypnotic. It affects chemicals in your brain that may become unbalanced and cause sleep problems (insomnia).
Lunata is used to treat insomnia.
Uses of Lunata in details
Zolpidem is used to treat sleep problems such as difficulty falling asleep, waking in the middle of the night, waking too early in adults that are causing distress and affecting every day life.
Lunata is a prescription short-acting nonbenzodiazepine hypnotic that potentiates gamma-aminobutyric acid (GABA), an inhibitory neurotransmitter, by binding to benzodiazepine receptors which are located on the gamma-aminobutyric acid receptors. Zolpidem is used for the short-term treatment of insomnia. It works quickly (usually within 15 minutes) and has a short half-life (2-3 hours). It is classified as an imidazopyridine. As an anticonvulsant and muscle relaxant, the beneficial effects start to emerge at 10 and 20 times the dose required for sedation, respectively. For that reason, it has never been approved for either muscle relaxation or seizure prevention. Recently, Zolpidem has been cited in various medical reports mainly in the United Kingdom as waking persistent vegetative state (PVS) patients, and dramatically improving the conditions of people with brain injuries. [Wikipedia]
KEEP OUT OF REACH OF CHILDREN.
Zolpidem side effects
The following serious adverse reactions in Zolpidem-treated patients are discussed in greater detail in other sections of the labeling:
- CNS-depressant effects and next-day impairment
- Serious anaphylactic and anaphylactoid reactions
- Abnormal thinking and behavioral changes, and complex behaviors
- Withdrawal effects
Clinical Trials ExperienceThe safety data described below are based on two double-blind placebo-controlled trials of Zolpidem in adult patients with insomnia characterized by difficulty returning to sleep after a middle-of-the-night awakening. These two trials included 230 and 82 patients treated with 3.5 mg and 1.75 mg of Zolpidem, respectively. The first study was a 3way crossover sleep-laboratory study in 82 patients (58 female and 24 male; median age 47 years; 51% Caucasian, 44% African-American) of 1.75 mg and 3.5 mg of Zolpidem compared to placebo (Study 1). The second study was a 4-week, parallel-group at-home study in 295 patients (201 female and 94 male; median age 43 years) of 3.5 mg of Zolpidem compared to placebo, used on an as-needed basis after spontaneous middle-of-the-night awakenings (Study 2). In Study 2, patients took Zolpidem during the night on 62% of study nights.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in actual practice.
Table 1 shows the incidence of adverse reactions reported in Study 2 that occurred in 2% or more of Zolpidem-treated (3.5 mg) patients in which the incidence was greater than the incidence in placebo-treated patients. For women and other patients taking the 1.75 mg dose in Study 1, the incidence of adverse reactions was similar to the incidence seen with 3.5 mg of Zolpidem in Table 1.
The most commonly reported adverse reactions in all treatment groups were headache, nausea, and fatigue.
Table 1: Summary of Adverse Reactions ( ≥ 2%) in Outpatient, Double-Blind, Parallel-Group, Placebo-Controlled Study (Study 2)
MedDRA System Organ Class Preferred Term
3.5 mg Zolpidem (n=150)
Gastrointestinal Disorders 4% 2% Nausea 1% 1% General Disorders and Administration Site Conditions 3% 0% Fatigue 1% 0% Nervous System Disorders 5% 3% Headache 3% 1% Postmarketing ExperienceThe following adverse reactions have been identified during post-approval use of Zolpidem. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to establish a causal relationship to drug exposure.
- Application site reactions, primarily in the sublingual area, have been reported. These application site reactions included oral ulcers, blisters, and mucosal inflammation.
In January 2013, the Food and Drug Administration (FDA) lowered the recommended dose for Zolpidem. If you have taken Zolpidem in the past, your doctor may direct you to take a lower dose of this medicine than you did before.
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 Zolpidem, 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.
Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking Zolpidem and talk with your doctor about another treatment for your sleep disorder.
Do not take this medicine if you have consumed alcohol during the day or just before bed.
Zolpidem may be habit forming. Keep the medication in a place where others cannot get to it.
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.
• This medicine causes drowsiness and impairs concentration and alertness. These effects may continue into the following day and are made worse by drinking alcohol. If you are affected you should avoid potentially hazardous tasks such as driving or operating machinery. Do not drink alcohol when taking this medicine.
• You should only take this medicine before going to bed at night. If you forget to take it at bedtime don’t take it at any other time, or you may end up feeling drowsy, dizzy and confused during the day.