Zolpidem (zolpidem tartrate)

Zolpidem is a sleep medicine and a GABA-A receptor positive modulator. The label we reviewed is for zolpidem tartrate tablets taken by mouth.

The label says it is for the short-term treatment of insomnia with difficulty falling asleep.

In controlled studies it shortened the time to fall asleep for up to 35 days. The trials lasted 4 to 5 weeks.

• Short-term treatment of insomnia with trouble starting sleep

The label says zolpidem is presumed to work by binding to the benzodiazepine site on GABA-A receptors that contain the alpha-1 subunit.

This increases the opening of chloride channels and so calms nerve cell activity.

This section covers the zolpidem tartrate tablet label for adults (5 mg and 10 mg tablets, oral route). Indian tablets and other forms can differ, and your prescriber decides.

The US label gives a usual starting dose of 5 mg for women and 5 or 10 mg for men, taken once a night immediately before bedtime with 7 to 8 hours left before waking. It says the dose should not exceed 10 mg once daily.

The label says elderly or debilitated people and those with mild to moderate liver impairment should have 5 mg. It says to avoid use in severe liver impairment.

The label says the tablet should not be taken again on the same night. It also says the effect may be slower if taken with or just after a meal.

The label says treatment should be as short as possible and that long-term use is not recommended, because abuse and dependence risk rises with duration.

• Once nightly, immediately before bed, with 7 to 8 hours left
• Daily limit of 10 mg on the US label
• 5 mg for elderly and mild to moderate liver impairment
• Do not repeat a dose the same night

The label has a boxed warning for complex sleep behaviours. These include sleep-walking, sleep-driving and other activities while not fully awake. Patients usually do not remember them, and some have led to serious injury or death.

The label says zolpidem must not be used by anyone who has had complex sleep behaviours with it, or with a known allergy to zolpidem.

It impairs alertness and coordination. Morning impairment, including impaired driving, is more likely with less than 7 to 8 hours of sleep left, with a higher dose, or with alcohol or other sedatives.

Worsening depression or suicidal thinking may occur. The label asks to reassess if insomnia lasts beyond 7 to 10 days.

Pregnancy: newborns exposed late in the third trimester have shown breathing depression and sedation. Breastfeeding: zolpidem passes into milk, and excess sedation in infants has been reported. Children: not recommended. Older adults: use 5 mg, because of falls and confusion.

• Stop if complex sleep behaviour occurs
• Do not use with alcohol or other sedatives
• Next-day driving impairment
• Pregnancy and breastfeeding: ask your doctor
• Not recommended for children

• Alcohol and CNS depressants: added sedation
• Opioids: breathing depression
• Rifampin, St. John's wort: lower levels
• Ketoconazole, sertraline: higher exposure
• Alcohol and other CNS depressants, such as benzodiazepines, opioids and tricyclic antidepressants, add to sedation and psychomotor impairment.
• Opioids may raise the risk of breathing depression.
• Imipramine and chlorpromazine reduce alertness when taken with it.
• Rifampin and St.
• John's wort can lower zolpidem levels and are not recommended.
• Ketoconazole can raise its effect.
• Sertraline increases zolpidem exposure.

No match in this label text. Ask your pharmacist about any medicine you take.

The label says overdose, alone or with other sedatives, has caused impaired consciousness from sleepiness to coma, heart and breathing problems, and deaths.

Care is supportive and given in hospital. The label notes flumazenil may reduce the sedative effect but can cause seizures. Treat any overdose as an emergency.

The US label says to store tablets at 20 to 25 degrees C, with excursions allowed from 15 to 30 degrees C.

Indian packs may carry their own storage line. Follow your pack, keep tablets out of reach of children, and do not share them.

Zolpidem is in Schedule H (serial 534) and also in Schedule H1 (serial 46), so it is sold only on a prescription.

The National List of Essential Medicines 2022 includes zolpidem as 5 mg and 10 mg tablets (page 103).

NPPA has ceiling prices for zolpidem tablets and a 5 mg capsule listing, shown below.

Banned combinations: the list we checked has no mentions of zolpidem. Use the checker for your exact combination.

NPPA ceiling prices set the most a seller can charge per unit before local taxes. Check the pack and the seller.

Jan Aushadhi lists zolpidem 5 mg and 10 mg tablets. We have not shown a brand price here.

• Zolpidem Tablets IP 10mg (pack 10's)
• Zolpidem Tablets IP 5mg (pack 10's)