Insomnia FAQ
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Ambien
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Pharmaceutical Name
Trade (marketing or proprietary) name: Ambien
Generic (nonproprietary or active ingredient) name: Zolpidem tartrate tablets
Indication and Usage
Reason the product has been approved for sale on the market.
The FDA approved this gamma-aminobutyric acid (GABA) A agonist for the short-term treatment of insomnia characterized by difficulties with sleep initiation.
Manufacturer Insert
Ingredients
Also known as “excipients” for vaccines.
Zolpidem tartrate, hydroxypropyl methylcellulose, lactose, magnesium stearate, micro crystalline 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.
Contraindications
Per the FDA, contraindications are conditions in a recipient that increases the risk for a serious adverse reaction. Product should not be administered when a patient has a listed contraindication.
Ambien is contraindicated in patients with known hypersensitivity to zolpidem. Observed reactions include anaphylaxis and angioedema.
Warnings and Precautions
Per the FDA, warnings are clinically significant adverse reactions or risks. According to the CDC, a precaution is a condition in a recipient that might increase the risk for a serious adverse reaction, might cause diagnostic confusion, or might compromise the effectiveness of the product. In general, a product should be deferred when a precaution is present.
CNS Depressant Effects and Next-Day Impairment: AMBIEN, like other sedative-hypnotic drugs, has central nervous system (CNS) depressant effects. Co-administration with other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of CNS depression. Dosage adjustments of AMBIEN and of other concomitant CNS depressants may be necessary when AMBIEN is administered with such agents because of the potentially additive effects. The use of AMBIEN with other sedative-hypnotics (including other zolpidem products) at bedtime or the middle of the night is not recommended.
Need to Evaluate for Co-morbid Diagnoses: 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. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated. Worsening of insomnia or the emergence of new thinking or behavior abnormalities may be the consequence of
an unrecognized psychiatric or physical disorder. Such findings have emerged during the course of treatment with sedative/hypnotic drugs, including zolpidem.
Severe Anaphylactic and Anaphylactoid Reactions: Cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including zolpidem. Some patients have had additional symptoms such as dyspnea, throat closing or nausea and vomiting that suggest anaphylaxis. Some patients have required medical therapy in the emergency department. If angioedema involves the throat, glottis or larynx, airway obstruction may occur and be fatal. Patients who develop angioedema after treatment with zolpidem should not be rechallenged with
the drug.
Abnormal Thinking and Behavioral Changes: Abnormal thinking and behavior changes have been reported in patients treated with sedative/hypnotics, including AMBIEN. Some of these changes included decreased inhibition (e.g., aggressiveness and extroversion that seemed out of character), bizarre behavior, agitation and depersonalization. Visual and auditory hallucinations have been reported. Complex behaviors such as “sleep-driving” (i.e., driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported in sedative-hypnotic-naive as well as in sedative-hypnotic-experienced persons. Although behaviors such as “sleep-driving” have occurred with AMBIEN alone at therapeutic doses, the co-administration of AMBIEN with alcohol and other CNS depressants increases the risk of such behaviors, as does the use of AMBIEN at doses exceeding the maximum recommended dose. Due to the risk to the patient and the community, discontinuation of AMBIEN should be strongly considered for patients who report a “sleep driving” episode. Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic. As with “sleep-driving”, patients usually do not remember these events. Amnesia, anxiety and other neuro-psychiatric symptoms may also occur. It can rarely be determined with certainty whether a particular instance of the abnormal behaviors listed above is drug induced, spontaneous in origin, or a result of an underlying psychiatric or physical disorder. Nonetheless, the emergence of any new behavioral sign or symptom of concern requires careful and immediate evaluation.
Use in Patients with Depression: In primarily depressed patients treated with sedative-hypnotics, worsening of depression, and suicidal thoughts and actions (including completed suicides), have been reported. Suicidal tendencies may be present in such patients and protective measures may be required. Intentional overdosage is more common in this group of patients; therefore, the lowest number of tablets that is feasible should be prescribed for the patient at any one time.
Respiratory Depression: Although studies with 10 mg zolpidem tartrate did not reveal respiratory depressant effects at hypnotic doses in healthy subjects or in patients with mild-to-moderate chronic obstructive pulmonary disease (COPD), a reduction in the Total Arousal Index, together with a reduction in lowest oxygen saturation and increase in the times of oxygen desaturation below 80% and 90%, was observed in patients with mild-to-moderate sleep apnea when treated with zolpidem compared to placebo. Since sedative-hypnotics have the capacity to depress respiratory drive, precautions should be taken if AMBIEN is prescribed to patients with compromised respiratory function. Post-marketing reports of respiratory insufficiency in patients receiving 10 mg of zolpidem tartrate, most of whom had pre-existing respiratory impairment, have been reported. The risk of respiratory depression should be considered prior to prescribing AMBIEN in patients with respiratory impairment including sleep apnea and myasthenia gravis.
Precipitation of Hepatic Encephalopathy: GABA agonists such as zolpidem tartrate have been associated with precipitation of hepatic encephalopathy in patients with hepatic insufficiency. In addition, patients with hepatic insufficiency do not clear zolpidem tartrate as rapidly as patients with normal hepatic function. Avoid AMBIEN use in patients with severe hepatic impairment as it may contribute to encephalopathy.
Withdrawal Effects: There have been reports of withdrawal signs and symptoms following the rapid dose decrease or abrupt discontinuation of zolpidem. Monitor patients for tolerance, abuse, and dependence.
Severe Injuries: Zolpidem can cause drowsiness and a decreased level of consciousness, which may lead to falls and consequently to severe injuries. Severe injuries such as hip fractures and intracranial hemorrhage have been reported.
Manufacturer-Listed Adverse Reactions
Per the CDC, adverse reactions are an undesirable medical condition that has been demonstrated to be caused by a vaccine. Evidence for the causal relation is usually obtained through randomized clinical trials, controlled epidemiologic studies, isolation of the vaccine strain from the pathogenic site, or recurrence of the condition with repeated vaccination (i.e., rechallenge); synonyms include side effect and adverse effect.
Angioedema involving the tongue, Glottis or larynx that may be fatal, Dyspnea, Throat closing, Nausea, Vomiting, Aggressiveness, Extroversion that seemed out of character, Bizarre behavior, Agitation, Depersonalization, Hallucinations, “Sleep-driving”, Other complex behaviors, Amnesia, Anxiety and other neuro-psychiatric symptoms, Worsening of depression including suicidal thoughts and actions (including completed suicides), Drowsiness, Dizziness, Headache, Vertigo, Falls, Diarrhea, Asthenia, Edema, Falling, Fatigue, Fever, Malaise, Trauma, Allergic reaction, Allergy aggravated, Anaphylactic Shock, Face edema, Hot flashes, Increased ESR, Pain, Restless legs, Rigors, Tolerance increased, Weight decrease, Cerebrovascular disorder, Hypertension, Tachycardia, Angina pectoris, Arrhythmia, Arteritis, Circulatory failure, Extrasystoles, Hypertension aggravated, Myocardial infarction, Phlebitis, Pulmonary embolism, Pulmonary edema, Varicose veins, Ventricular tachycardia, Ataxia, Confusion, Euphoria, Headache, Insomnia, Vertigo, Agitation, Decreased cognition, Detached, Difficulty concentrating, Dysarthria, Emotional lability, Hypoesthesia, Illusion, Leg cramps, Migraine, Nervousness, Paresthesia, Sleeping (after daytime dosing), Speech disorder, Stupor, Tremor, 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, Dyspepsia, Hiccup, Nausea, Anorexia, Constipation, Dysphagia, Flatulence, Gastroenteritis, Enteritis, Eructation, Esophagospasm, Gastritis, Hemorrhoids, Intestinal obstruction, Rectal hemorrhage, Tooth caries, Anemia, Hyperhemoglobinemia, Leukopenia, Lymphadenopathy, Macrocytic anemia, Purpura, Thrombosis, Infection, Abscess herpes simplex herpes zoster, Otitis externa, Otitis media, Abnormal hepatic function, Increased SGPT, Bilirubinemia, Increased SGOT, Hyperglycemia, Thirst, Gout, Hypercholesteremia, Hyperlipidemia, Increased alkaline phosphatase, Increased BUN, Periorbital edema, Arthralgia, Myalgia, Arthritis, Arthrosis, Muscle weakness, Sciatica, Tendinitis, Menstrual disorder, Vaginitis, Breast fibroadenosis, Breast neoplasm, Breast pain, Upper respiratory infection, Lower respiratory infection, Bronchitis, Coughing, Dyspnea, Rhinitis, Bronchospasm, Respiratory depression, Epistaxis, Hypoxia, Laryngitis, Pneumonia, Pruritus, Acne, Bullous eruption, Dermatitis, Furunculosis, Injection-site inflammation, Photosensitivity reaction, Urticaria (hives), Diplopia, Vision abnormal, Eye irritation, Eye pain, Scleritis, Taste perversion, Tinnitus, Conjunctivitis, Corneal ulceration, Lacrimation, Parosmia, Photopsia, Urinary tract infection, Cystitis, Urinary incontinence, Acute renal failure, Dysuria, Micturition frequency, Nocturia, Polyuria, Pyelonephritis, Renal pain, Urinary retention.
Specific Populations
Pregnancy
There are no adequate and well-controlled studies of AMBIEN in pregnant women.
Studies in children to assess the effects of prenatal exposure to zolpidem have not been
conducted; however, cases of severe neonatal respiratory depression have been reported when zolpidem was used at the end of pregnancy, especially when taken with other CNS-depressants. Children born to mothers taking sedative-hypnotic drugs may be at risk for withdrawal symptoms during the postnatal period. Neonatal flaccidity has also been reported in infants born to mothers who received sedative-hypnotic drugs during pregnancy. AMBIEN should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.
AMBIEN has no established use in labor and delivery.
Breastfeeding
Zolpidem is excreted in human milk. Caution should be exercised when AMBIEN is administered to a nursing woman.
Pediatric
AMBIEN is not recommended for use in children. Safety and effectiveness of zolpidem in pediatric patients below the age of 18 years have not been established.
Mechanism of Action
This is the specific biochemical interaction through which a drug or vaccine substance produces its pharmacological effect. This section also includes the minimum protective level designated for a certain disease.
Zolpidem, the active moiety of zolpidem tartrate, is a hypnotic agent with a chemical structure unrelated to benzodiazepines, barbiturates, or other drugs with known hypnotic properties. It interacts with a GABA-BZ receptor complex and shares some of the pharmacological properties of the benzodiazepines. In contrast to the benzodiazepines, which non-selectively bind to and activate all BZ receptor subtypes, zolpidem in vitro binds the BZ1 receptor preferentially with a high affinity ratio of the α1/α5 subunits. This selective binding of zolpidem on the BZ1 receptor is not absolute, but it may explain the relative absence of myorelaxant and anticonvulsant effects in animal studies as well as the preservation of deep sleep (stages 3 and 4) in human studies of zolpidem tartrate at hypnotic doses.
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