Zolpidem

PRODUCT DESCRIPTION

Zolpidem is a sedative, also called a hypnotic. It affects chemicals in the brain that may be unbalanced in people with sleep problems (insomnia).

Zolpidem is used to treat insomnia. The immediate-release forms are Ambien, Intermezzo, Edluar, and Zolpimist, which are used to help you fall asleep. The extended-release form of zolpidem is Ambien CR, which has a first layer that dissolves quickly to help you fall asleep, and a second layer that dissolves slowly to help you stay asleep.

Ambien, Edluar, and Zolpimist are used to help you fall asleep when you first go to bed. Intermezzo, is used to help you fall back to sleep if you wake up in the middle of the night and then have trouble sleeping.

Your doctor will determine which form of zolpidem is best for you.

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.

Before taking this medicine

Some people using this medicine have engaged in activity such as driving, eating, walking, making phone calls, or having sex 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.

You should not use this medicine if you are allergic to zolpidem. The tablets may contain lactose. Use caution if you are sensitive to lactose.

To make sure zolpidem is safe for you, tell your doctor if you have:

• kidney disease;
• liver disease;
• lung disease such as asthma, bronchitis, emphysema, or chronic obstructive pulmonary disease (COPD);
• sleep apnea (breathing stops during sleep);
• myasthenia gravis;
• a history of depression, mental illness, or suicidal thoughts; or
• a history of drug or alcohol addiction.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

What should I avoid while taking zolpidem?

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 until you are fully awake before you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert.

DOSAGE METHOD

Usual Adult Dose for Insomnia

IMMEDIATE RELEASE (IR) TABLET, ORAL SPRAY, and SUBLINGUAL TABLET (EDLUAR):

-Initial Dose: 5 mg (Women) OR 5 mg or 10 mg (Men)

-Maintenance Dose: The dose may be increased to 10 mg if the 5 mg dose is not effective.

-Maximum Dose: 10 mg once a day.

-Duration of Therapy: The clinical trials in support of efficacy were 4 to 5 weeks in duration.

 

CONTROLLED/EXTENDED RELEASE (CR/ER) TABLET:

-Initial Dose: 6.25 mg (Women) OR 6.25 mg or 12.5 mg (Men)

-Maintenance Dose: The dose may be increased to 12.5 mg if the 6.25 mg dose is not effective.

-Maximum Dose: 12.5 mg once a day.

-Duration of Therapy: The clinical trials in support of efficacy were up to 3 and 24 weeks in duration.

 

SUBLINGUAL TABLET (INTERMEZZO):

-Initial and Maximum Dose: 1.75 mg (Women) OR 3.5 mg (Men)

Comments: The recommended initial doses for women and men are different due to the lower rate of drug clearance in females.

Use:

-IR Tablet, Oral Spray, and Sublingual Tablet (Edluar): Short-term treatment of insomnia characterized by difficulties with sleep initiation.

-CR/ER Tablet: Treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset).

-Sublingual Tablet (Intermezzo): As needed treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep.

Usual Geriatric Dose for Insomnia

DEBILITATED PATIENTS:

-Immediate Release (IR) Tablet, Oral Spray, and Sublingual Tablet (Edluar): 5 mg

-Controlled/Extended Release (CR/ER) Tablet: 6.25 mg

-Sublingual Tablet (Intermezzo): Data not available.

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule IV

Dialysis

This drug is not dialyzable.

NEGATIVE EFFECTS

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

Report any new or worsening symptoms to your doctor, such as: depression, anxiety, aggression, agitation, confusion, unusual thoughts, hallucinations, memory problems, changes in personality, risk-taking behavior, decreased inhibitions, no fear of danger, or thoughts of suicide or hurting yourself.

Stop using zolpidem and call your doctor at once if you have:

• chest pain, fast or irregular heartbeat, feeling short of breath;
• trouble breathing or swallowing; or
• feeling like you might pass out.

Common zolpidem side effects may include:

• daytime drowsiness, dizziness, weakness, feeling “drugged” or light-headed;
• tired feeling, loss of coordination;
• stuffy nose, dry mouth, nose or throat irritation;
• nausea, constipation, diarrhea, upset stomach; or
• headache, muscle pain.

Disclaimer

While every effort has been taken to ensure that the information provided is accurate, up-to-date and complete, Prime Medical Pharma cannot guarantee its accuracy. Please note that the drug information contained herein may be time-sensitive and should not be relied upon beyond the date hereof. This material is intended as a reference resource and should not be used as a substitute for the expertise, skill, knowledge, and judgment of healthcare practitioners in patient care. It is important to note that the absence of a warning for a given drug or combination thereof does not imply safety, effectiveness, or appropriateness for any particular patient. This material does not endorse drugs, diagnose patients, or recommend therapy.