Zolpidem
(Redirected from Stilnoct)
What is Zolpidem?[edit | edit source]
- Zolpidem (Edular, Ambien) a gamma-aminobutyric acid (GABA) A receptor positive modulator used for the treatment of insomnia.
What are the uses of this medicine?[edit | edit source]
- Zolpidem tartrate tablets is a sedative-hypnotic (sleep) medicine. Zolpidem tartrate tablets is used in adults for the short-term treatment of a sleep problem called insomnia.
Symptoms of insomnia include:
- trouble falling asleep
How does this medicine work?[edit | edit source]
- Zolpidem, the active moiety of zolpidem tartrate, is a hypnotic agent.
- Zolpidem binds selectively to the alpha 1 subunit of the omega-1 (BZ1) receptor of the gamma-aminobutyric acid type A (GABA-A ) receptor-chloride ionophore complex, thereby opening neuronal chloride channels, hyperpolarizing neuronal cell membranes, and inhibiting neuronal firing.
- In contrast, benzodiazepines non-selectively bind to and activate all omega receptor subtypes, exhibiting anticonvulsant and myorelaxant activities in addition to a sedative-hypnotic activity.
Who Should Not Use this medicine ?[edit | edit source]
This medicine cannot be used in patients with:
- Known hypersensitivity to zolpidem tartrate or to any of the inactive ingredients in the formulation
What drug interactions can this medicine cause?[edit | edit source]
- Do not take zolpidem tartrate tablets with other medicines that can make you sleepy.
- combination use with CNS depressants may enhances CNS depressant effects with combination use. Use with alcohol causes additive psychomotor impairment.
- Decreased alertness is observed when combination use with Imipramine.
- Impaired alertness and psychomotor performance observed with combination use of Chlorpromazine.
- Combination use with rifampin may decrease exposure to, and effects of zolpidem.
- Combination use with ketoconazole may increase exposure to and effect of zolpidem
Is this medicine FDA approved?[edit | edit source]
- Zolpidem was approved for medical use in the United States in 1992.
How should this medicine be used?[edit | edit source]
Recommended dosage:
- Adult dose: 10 mg once daily immediately before bedtime.
- Elderly/debilitated patients/hepatically impaired: 5 mg once daily immediately before bedtime.
Edular dosing:
- Recommended dose is 5 mg for women and 5 or 10 mg for men, immediately before bedtime.
- Geriatric patients and patients with hepatic impairment: Recommended dose is 5 mg for men and women.
Ambien dosing:
- Use the lowest dose effective for the patient and must not exceed a total of 10 mg daily.
- Recommended initial dose is a single dose of 5 mg for women and a single dose of 5 or 10 mg for men, immediately before bedtime with at least 7–8 hours remaining before the planned time of awakening.
- Geriatric patients and patients with mild to moderate hepatic impairment: Recommended dose is 5 mg for men and women.
Extended-Release Tablets:
- Use the lowest dose effective for the patient and must not exceed a total of 12.5 mg daily.
- Recommended initial dose is a single dose of 6.25 mg for women and a single dose of 6.25 or 12.5 mg for men, immediately before bedtime with at least 7 to 8 hours remaining before the planned time of awakening.
- Geriatric patients and patients with mild to moderate hepatic impairment: Recommended dose is 6.25 mg for men and women
Administration: AMBIEN:
- Take AMBIEN exactly as prescribed. Only take 1 AMBIEN tablet a night if needed.
- Do not take AMBIEN if you drank alcohol that evening or before bed.
- You should not take AMBIEN with or right after a meal. AMBIEN may help you fall asleep faster if you take it on an empty stomach.
Edluar:
- Only take 1 Edluar tablet a night and only if needed.
- Do not take Edluar if you drank alcohol that evening or before bed.
- You should not take Edluar with or right after a meal. Edluar may help you fall asleep faster if you take it on an empty stomach.
- Place the tablet under the tongue, where it will disintegrate. Do not swallow or take with water.
What are the dosage forms and brand names of this medicine?[edit | edit source]
This medicine is available in fallowing doasage form:
- As 5 mg and 10 mg tablets. Tablets not scored
- Sublingual tablets: 5 mg and 10 mg. Tablets not scored.
- Extended-Release Tablets: 6.25 mg and 12.5 mg. Tablets not scored.
This medicine is available in fallowing brand namesː
- AMBIEN ; Edluar
What side effects can this medication cause?[edit | edit source]
The most common side effects of this medicine include:
- drowsiness
- dizziness
- diarrhea
- “drugged feelings”
This medicine may cause serious side effects, including:
- getting out of bed while not being fully awake and do an activity that you do not know you are doing
- abnormal thoughts and behavior
- memory loss
- anxiety
- severe allergic reactions
What special precautions should I follow?[edit | edit source]
- Because sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia should be initiated only after a careful evaluation of the patient. Reevaluate if insomnia persists after 7 to 10 days of use.
- Angioedema and anaphylaxis have been reported. Do not rechallenge if such reactions occur.
- A variety of abnormal thinking and behavior changes have been reported to occur in association with the use of sedative/hypnotics. May include "sleep-driving" and hallucinations. Immediately evaluate any new onset behavioral changes.
- Worsening of depression or, suicidal thinking may occur. Prescribe the least amount feasible to avoid intentional overdose.
- Following the rapid dose decrease or abrupt discontinuation of sedative/hypnotics, there have been reports of signs and symptoms similar to those associated with withdrawal from other CNS-depressant drugs.
- Zolpidem tartrate tablets showed additive effects when combined with alcohol and should not be taken with alcohol. Patients should also be cautioned about possible combined effects with other CNS-depressant drugs. Dosage adjustments may be necessary when zolpidem tartrate tablets are administered with such agents because of the potentially additive effects.
- Patients with hepatic impairment, mild to moderate COPD, impaired drug metabolism or hemodynamic responses, mild to moderate sleep apnea; Use with caution and monitor closely.
What to do in case of emergency/overdose?[edit | edit source]
Symptoms of overdosage may include:
- impairment of consciousness
- somnolence
- coma
Management of overdosage:
- General symptomatic and supportive measures should be used along with immediate gastric lavage where appropriate.
- Intravenous fluids should be administered as needed.
- Zolpidem’s sedative hypnotic effect was shown to be reduced by flumazenil and therefore may be useful.
- Hypotension and CNS depression should be monitored and treated by appropriate medical intervention.
- As in all cases of drug overdose, respiration, pulse, blood pressure, and other appropriate signs should be monitored and general supportive measures employed.
- zolpidem is not dialyzable.
Can this medicine be used in pregnancy?[edit | edit source]
- There are no adequate and well-controlled studies of zolpidem tartrate tablets in pregnant women.
- Zolpidem tartrate tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Can this medicine be used in children?[edit | edit source]
- Safety and effectiveness of zolpidem have not been established in pediatric patients.
What are the active and inactive ingredients in this medicine?[edit | edit source]
- Active Ingredient: zolpidem tartrate
- Inactive Ingredients: hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide; the 5 mg tablet also contains red ferric oxide.
Edular:
- Active Ingredient: zolpidem tartrate
- Inactive Ingredients: mannitol, colloidal silicon dioxide, silicified microcrystalline cellulose, croscarmellose sodium, saccharin sodium, and magnesium stearate.
Ambien:
- Active Ingredient: Zolpidem tartrate
- Inactive Ingredients: hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. In addition, the 5 mg tablet contains FD&C Red No. 40, iron oxide colorant, and polysorbate 80.
Who manufactures and distributes this medicine?[edit | edit source]
Edular: Manufactured by:
- Mylan Laboratories Limited
- Hyderabad – 500 096, India
Manufactured for: Meda Pharmaceuticals Inc. Somerset, NJ
Ambien:
- sanofi-aventis U.S. LLC
- Bridgewater, NJ
What should I know about storage and disposal of this medication?[edit | edit source]
- Store zolpidem tartrate tablets at room temperature, 68° to 77°F (20° to 25°C).
- Keep zolpidem tartrate tablets and all medicines out of reach of children.
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