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- What is zolpidem, and how does it work (mechanism of action)?
- What brand names are available for zolpidem?
- Is zolpidem available as a generic drug?
- Do I need a prescription for zolpidem?
- What are the uses for zolpidem?
- What are the side effects of zolpidem?
- What is the dosage for zolpidem?
- Which drugs or supplements interact with zolpidem?
- Is zolpidem safe to take if I'm pregnant or breastfeeding?
- What else should I know about zolpidem?
What is zolpidem, and how does it work (mechanism of action)?
- Zolpidem belongs to a class of drugs called sedatives or hypnotics. Zolpidem shares some characteristics of a family of sedatives called benzodiazepines. Benzodiazepines cause sedation, muscle relaxation, act as anti-convulsants (anti-seizure medications), and reduce anxiety. Zolpidem has selectivity in that it has little of the muscle relaxant and anti-seizure effects and more of the sedative effect. Therefore, it is used primarily as a medication for sleep. The oral spray form of zolpidem, Zolpimist, has more rapid absorption than the tablet form because it is absorbed through the lining of the mouth.
The FDA approved zolpidem in December 1992.
What are the uses for zolpidem?
- Zolpidem is used for treating insomnia.
- Conventional tablets are used for short-term treatment of insomnia associated with difficulty falling asleep.
- Long acting tablets are used for treating insomnia associated with difficulty falling asleep or staying asleep.
- Zolpidem improves initiation of sleep and keeps patients asleep longer.
What are the side effects of zolpidem?
The most common side effects of zolpidem are:
- A "drugged" feeling, which probably reflect the action of the drug
Other side effects include:
- Dry mouth
- Ataxia (balance problems), and
- Visual changes.
Zolpidem can cause withdrawal symptoms (muscle cramps, sweats, shaking, and seizures) when the drug is abruptly discontinued. Zolpidem can cause abnormal behavior with confusion, paradoxical insomnia or "complex sleep-related behaviors," which may include sleep-driving (driving with no memory of having done so). If these side effects occur, zolpidem should be discontinued.
What is the dosage for zolpidem?
- The recommended adult dose of zolpidem conventional tablets or spray is 5 mg for females, the elderly, or fragile individuals, and 5 to 10 mg for males.
- The maximum dose is 10 mg daily.
- For females and the elderly, give 6.25 mg of extended-release tablets; and males should receive 6.25 to 12.5 mg.
- The maximum dose of extended-release tablets is 12.5 mg daily.
- Elderly patients have decreased ability to eliminate zolpidem from the body, and accumulating zolpidem may cause side effects.
Which drugs or supplements interact with zolpidem?
- Alcohol has an additive effect with zolpidem and the two should not be combined. Zolpidem should not be combined with other sedative drugs because of the additive effects.
- Itraconazole (Sporanox) and ketoconazole (Nizoral, Extina, Xolegel, Kuric) may increase the blood concentration of zolpidem by reducing the activity of the enzymes that breakdown zolpidem in the liver. Conversely, rifampin may reduce the concentration of zolpidem by increasing the activity of the enzymes that breakdown zolpidem.
Is zolpidem safe to take if I'm pregnant or breastfeeding?
What else should I know about zolpidem?
What preparations of zolpidem are available?
- Tablets: 5 and 10 mg.
- Tablet (extended release): 6.25 mg and 12.5 mg.
- Oral spray: 5 mg/spray
How should I keep zolpidem stored?
Zolpidem should be stored at room temperature, 20-25 C (68-77 F), in an air-tight container.
Zolpidem (Ambien, Ambien CR, Zolpimist, Edluar, [Tovalt ODT has been discontinued]) is a sedative medication prescribed for the treatment of insomnia. Side effects, drug interactions, warnings and precautions, and pregnancy and breastfeeding safety information should be reviewed prior to taking any medication.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
FDA Prescribing Information for zolpidem
AHFS Drug Information for zolpidem
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Hypnotics Drug Class Side Effects
Hypnotics are sleep medications used to treat different types of insomnia. There are a variety of hypnotic drugs, and they are grouped into five types. Benzodiazepines, nonbenzodiazepines, selective melatonin agonists (these three drug types are classified as sedatives), antidepressants, and an orexin receptor agonist. Some hypnotics can be addictive and may cause withdrawal symptoms if discontinued abruptly.
The side effects of hypnotics depend upon the drug used, but they may include:
- Dry mouth
- Rebound insomnia
Other side effects may include:
- Hair loss
- Dry skin
- Upset stomach
- Abnormal dreams
Hypnotics may have serious side effects and adverse effects, for example:
- Abnormal thinking
- Suicidal thinking
- Sleep paralysis
- Sleep driving and other complex behavior
- Exfoliate dermatitis
Hypnotic drugs available over-the-counter (OTC) include diphenhydramine (Benadryl) and doxylamine (Unisom). Natural herbal supplements used for insomnia are melatonin and Valerian.
Do not drink alcohol while taking hypnotic drugs. Stimulants like caffeine or amphetamines reduce the effect of insomnia medications.
Your doctor or other health care professional will recommend the type of hypnotic drug for you depending upon the type of sleep problem you have, your current lifestyle habits, other medications you are taking, and any other medical problems you may have.
FDA. "Sleep Disorder (Sedative-Hypnotic) Drug Information." Updated: Jun 13, 2017.
Chawala, J, MD. "Insomnia Medication." Medscape. Updated: Aug 01, 2016.
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