Zolpimist

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Zolpimist Side Effects Center

What Is Zolpimist?

Zolpimist (zolpidem tartrate) Oral Spray is a non-benzodiazepine sedative hypnotic used to treat insomnia.

What Are Side Effects of Zolpimist?

Common side effects of Zolpimist Oral Spray include dizziness, daytime drowsiness, weakness, feeling "drugged," lightheadedness, tired feeling, loss of coordination, stuffy nose, dry mouth, nose or throat irritation, nausea, constipation, diarrhea, upset stomach, headache, or muscle pain. Rarely, after using Zolpimist Oral Spray, people have driven in their sleep, sleepwalked, prepared or eaten food, made phone calls, or had sex while not fully awake, and you may not remember these events. This problem can be dangerous to you or to others. If you find out you have done any of these activities after using Zolpimist Oral Spray, tell your doctor.

Dosage for Zolpimist

The recommended dose of Zolpimist for adults is 10 mg once daily immediately before bedtime.

What Drugs, Substances, or Supplements Interact with Zolpimist?

Zolpimist may interact with other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxants, and medicine for depression or anxiety), chlorpromazine, itraconazole, ketoconazole, rifampin, or antidepressants. Tell your doctor all medications and supplements you use.

Zolpimist During Pregnancy and Breastfeeding

During pregnancy, Zolpimist should be used only if prescribed. Infants born to mothers who have used sedative-hypnotics near the time of delivery may have undesirable effects such as breathing problems or withdrawal symptoms. A small amount of this medication passes into breast milk. Consult your doctor before breastfeeding. Withdrawal symptoms may occur if you suddenly stop taking this medication.

Additional Information

Our Zolpimist (zolpidem tartrate) Oral Spray Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Zolpimist Consumer Information

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; or
• feeling like you might pass out.

Common side effects may include:

• daytime drowsiness, dizziness, feeling "drugged" or light-headed;
• headache;
• diarrhea; or
• 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.

Read the entire detailed patient monograph for Zolpimist (Zolpidem Tartrate Oral Spray)

 

Zolpimist Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed in greater detail in other sections of the labeling:

• Complex Sleep Behaviors [see WARNINGS AND PRECAUTIONS]
• CNS-Depressant Effects and Next Day Impairment [see WARNINGS AND PRECAUTIONS]
• Serious anaphylactic and anaphylactoid reactions [see WARNINGS AND PRECAUTIONS]
• Abnormal Thinking and Behavioral Changes [see WARNINGS AND PRECAUTIONS]
• Withdrawal Effects [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

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 practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating incidence rates.

Associated With Discontinuation Of Treatment

Approximately 4% of 1,701 patients who received zolpidem tartrate at all doses (1.25 to 90 mg) in U.S. premarketing clinical trials discontinued treatment because of an adverse reaction. Reactions most commonly associated with discontinuation from U.S. trials were daytime drowsiness (0.5%), dizziness (0.4%), headache (0.5%), nausea (0.6%), and vomiting (0.5%).

Approximately 4% of 1,959 patients who received zolpidem at all doses (1 to 50 mg) in similar foreign trials discontinued treatment because of an adverse reaction. Reactions most commonly associated with discontinuation from these trials were daytime drowsiness (1.1%), dizziness/vertigo (0.8%), amnesia (0.5%), nausea (0.5%), headache (0.4%), and falls (0.4%).

Data from a clinical study in which selective serotonin reuptake inhibitor (SSRI)-treated patients were given zolpidem revealed that four of the seven discontinuations during double-blind treatment with zolpidem (n=95) were associated with impaired concentration, continuing or aggravated depression, and manic reaction; one patient treated with placebo (n=97) was discontinued after an attempted suicide.

Most Commonly Observed Adverse Reactions In Controlled Trials

During short-term treatment (up to 10 nights) with zolpidem tartrate at doses up to 10 mg, the most commonly observed adverse reactions associated with the use of zolpidem and seen at statistically significant differences from placebotreated patients were drowsiness (reported by 2% of zolpidem patients), dizziness (1%), and diarrhea (1%). During longer-term treatment (28 to 35 nights) with zolpidem tartrate at doses up to 10 mg, the most commonly observed adverse reactions associated with the use of zolpidem and seen at statistically significant differences from placebo-treated patients were dizziness (5%) and drugged feelings (3%).

Adverse Reactions Observed At An Incidence Of ≥1% In Controlled Trials

The following tables enumerate treatment-emergent adverse reactions frequencies that were observed at an incidence equal to 1% or greater among patients with insomnia who received zolpidem tartrate and at a greater incidence than placebo in U.S. placebo-controlled trials. Events reported by investigators were classified utilizing a modified World Health Organization (WHO) dictionary of preferred terms for the purpose of establishing event frequencies. The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice, in which patient characteristics and other factors differ from those that prevailed in these clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigators involving related drug products and uses, since each group of drug trials is conducted under a different set of conditions. However, the cited figures provide the physician with a basis for estimating the relative contribution of drug and nondrug factors to the incidence of side effects in the population studied.

The following table was derived from results of 11 placebo-controlled short-term U.S. efficacy trials involving zolpidem in doses ranging from 1.25 to 20 mg. The table is limited to data from doses up to and including 10 mg, the highest dose recommended for use.

Incidence of Treatment-Emergent Adverse Reactions in Placebo-Controlled Clinical Trials Lasting up to 10 Nights (Percentage of patients reporting)

Body System/Adverse Reaction*	Zolpidem (≤10mg) (n=685)	Placebo (n=473)
Central and Peripheral Nervous System
Headache	7	6
Drowsiness	2	-
Dizziness	1	-
Gastrointestinal System
Diarrhea	1	-
*Reactions reported by at least 1% of patients treated with zolpidem tartrate and at a greater frequency than placebo.

The following table was derived from results of three placebo-controlled long-term efficacy trials involving zolpidem tartrate. These trials involved patients with chronic insomnia who were treated for 28 to 35 nights with zolpidem tartrate at doses of 5, 10, or 15 mg. The table is limited to data from doses up to and including 10 mg, the highest dose recommended for use. The table includes only adverse reactions occurring at an incidence of at least 1% for zolpidem tartrate patients.

Incidence of Treatment-Emergent Adverse Reactions in Placebo-Controlled Clinical Trials Lasting up to 35 Nights (Percentage of patients reporting)

Body System/Adverse Reaction*	Zolpidem (≤10mg) (n=152)	Placebo (n=161)
Autonomic Nervous System
Dry mouth	3	1
Body as a Whole
Allergy	4	1
Back pain	3	2
Influenza-like symptoms	2	-
Chest pain	1	-
Cardiovascular System
Palpitation	2	-
Central and Peripheral Nervous System
Drowsiness	8	5
Dizziness	5	1
Lethargy	3	1
Drugged feeling	3	-
Lightheadedness	2	1
Depression	2	1
Abnormal dreams	1	-
Amnesia	1	-
Sleep disorder	1	-
Gastrointestinal System
Diarrhea	3	2
Abdominal pain	2	2
Constipation	2	1
Respiratory System
Sinusitis	4	2
Pharyngitis	3	1
Skin and Appendages
Rash	2	1
*Reactions reported by at least 1% of patients treated with zolpidem tartrate and at a greater frequency than placebo.

Dose Relationship For Adverse Reactions

There is evidence from dose comparison trials suggesting a dose relationship for many of the adverse reactions associated with zolpidem tartrate use, particularly for certain CNS and gastrointestinal adverse reactions.

Oral Tissue-Related Adverse Reactions In ZOLPIMIST Pharmacokinetics Studies

The effect of chronic daily administrations of ZOLPIMIST on oral tissue has not been evaluated. In pharmacokinetic studies conducted with ZOLPIMIST in healthy subjects, an oral soft tissue exam was performed, and no signs of oral irritation were noted following administration of single doses of ZOLPIMIST.

Adverse Event Incidence Across The Entire Preapproval Database

Zolpidem tartrate was administered to 3,660 subjects in clinical trials throughout the United States, Canada, and Europe. Treatment-emergent adverse event associated with clinical trial participation were recorded by clinical investigators using terminology of their own choosing. To provide a meaningful estimate of the proportion of individuals experiencing treatment-emergent adverse events, similar types of untoward events were grouped into a smaller number of standardized event categories and classified utilizing a modified WHO dictionary of preferred terms.

The frequencies presented, therefore, represent the proportions of the 3,660 individuals exposed to zolpidem tartrate, at all doses, who experienced an event of the type cited on at least one occasion while receiving zolpidem tartrate. All reported treatment-emergent adverse events are included, except those already listed in the table above of adverse events in placebo-controlled studies, those coding terms that are so general as to be uninformative, and those events where a drug cause was remote. It is important to emphasize that, although the events reported did occur during treatment with zolpidem tartrate, they were not necessarily caused by it.

Adverse events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are defined as those occurring in greater than 1/100 subjects; infrequent adverse events are those occurring in 1/100 to 1/1,000 patients; rare events are those occurring in less than 1/1,000 patients.

Autonomic nervous system: Infrequent: increased sweating, pallor, postural hypotension, syncope. Rare: abnormal accommodation, altered saliva, flushing, glaucoma, hypotension, impotence, increased saliva, tenesmus.

Body as a whole: Frequent: asthenia. Infrequent: edema, falling, fatigue, fever, malaise, trauma. Rare: allergic reaction, allergy aggravated, anaphylactic shock, face edema, hot flashes, increased ESR, pain, restless legs, rigors, tolerance increased, weight decrease.

Cardiovascular system: Infrequent: cerebrovascular disorder, hypertension, tachycardia. Rare: angina pectoris, arrhythmia, arteritis, circulatory failure, extrasystoles, hypertension aggravated, myocardial infarction, phlebitis, pulmonary embolism, pulmonary edema, varicose veins, ventricular tachycardia.

Central and peripheral nervous system: Frequent: ataxia, confusion, euphoria, headache, insomnia, vertigo. Infrequent: agitation, anxiety, decreased cognition, detached, difficulty concentrating, dysarthria, emotional lability, hallucination, hypoesthesia, illusion, leg cramps, migraine, nervousness, paresthesia, sleeping (after daytime dosing), speech disorder, stupor, tremor. Rare: abnormal gait, abnormal thinking, aggressive reaction, apathy, appetite increased, decreased libido, delusion, dementia, depersonalization, dysphasia, feeling strange, hypokinesia, hypotonia, hysteria, intoxicated feeling, manic reaction, neuralgia, neuritis, neuropathy, neurosis, panic attacks, paresis, personality disorder, somnambulism, suicide attempts, tetany, yawning.

Gastrointestinal system: Frequent: dyspepsia, hiccup, nausea. Infrequent: anorexia, constipation, dysphagia, flatulence, gastroenteritis, vomiting. Rare: enteritis, eructation, esophagospasm, gastritis, hemorrhoids, intestinal obstruction, rectal hemorrhage, tooth caries.

Hematologic and lymphatic system: Rare: anemia, hyperhemoglobinemia, leukopenia, lymphadenopathy, macrocytic anemia, purpura, thrombosis. Immunologic system: Infrequent: infection. Rare: abscess, herpes simplex, herpes zoster, otitis externa, otitis media.

Liver and biliary system: Infrequent: abnormal hepatic function, increased SGPT. Rare: bilirubinemia, increased SGOT.

Metabolic and nutritional: Infrequent: hyperglycemia, thirst. Rare: gout, hypercholesteremia, hyperlipidemia, increased alkaline phosphatase, increased BUN, periorbital edema.

Musculoskeletal system: Frequent: arthralgia, myalgia. Infrequent: arthritis. Rare: arthrosis, muscle weakness, sciatica, tendonitis.

Reproductive system: Infrequent: menstrual disorder, vaginitis. Rare: breast fibroadenosis, breast neoplasm, breast pain.

Respiratory system: Frequent: upper respiratory infection, lower respiratory infection. Infrequent: bronchitis, coughing, dyspnea, rhinitis. Rare: bronchospasm, respiratory depression, epistaxis, hypoxia, laryngitis, pneumonia.

Skin and appendages: Infrequent: pruritus. Rare: acne, bullous eruption, dermatitis, furunculosis, injection-site inflammation, photosensitivity reaction, urticaria.

Special senses: Frequent: diplopia, vision abnormal. Infrequent: eye irritation, eye pain, scleritis, taste perversion, tinnitus. Rare: conjunctivitis, corneal ulceration, lacrimation abnormal, parosmia, photopsia.

Urogenital system: Frequent: urinary tract infection. Infrequent: cystitis, urinary incontinence. Rare: acute renal failure, dysuria, micturition frequency, nocturia, polyuria, pyelonephritis, renal pain, urinary retention.

Read the entire FDA prescribing information for Zolpimist (Zolpidem Tartrate Oral Spray)

&Copy; Zolpimist Patient Information is supplied by Cerner Multum, Inc. and Zolpimist Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.