Zolpidem

What is Zolpidem?

• Zolpidem (Edular, Ambien) a gamma-aminobutyric acid (GABA) A receptor positive modulator used for the treatment of insomnia.

Zolpidem

Zolpidem molecule ball

What are the uses of this medicine?

• 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?

• 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 ?

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?

• 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?

• Zolpidem was approved for medical use in the United States in 1992.

How should this medicine be used?

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?

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?

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?

• 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?

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?

• 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?

• Safety and effectiveness of zolpidem have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

• 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?

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?

• 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.

• Dailymed label info on Zolpidem
• FDA Zolpidem

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