Somno

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Somno

Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Somno

What is Somno? Defining the Hypnotic Agent

This section defines the identity and classification of Somno (Zolpidem), providing clear, factual context without detailing specific usage instructions.

Property Description
Active ingredient Zolpidem Tartrate (INN)
Form Oral tablet
Pharmacological class Non-benzodiazepine receptor modulator (Z-drug)
Common use Short-term management of sleep initiation and/or sleep maintenance difficulties
Origin Synthetic compound (imidazopyridine class)

What Type of Medicine is Somno?

Somno is the trade name for a sedative-hypnotic agent prescribed to assist with sleep difficulties, whose active ingredient is Zolpidem Tartrate. This drug is classified as a Non-benzodiazepine receptor modulator, commonly referred to as a Z-drug, which structurally differentiates it from older hypnotic medications. Its status as a prescription-only medication (Rx) is globally consistent due to its targeted action on the central nervous system. The compound is clinically recognized for its efficacy in rapidly modulating brain activity to facilitate the onset of rest.

Composition, Form, and Origin of the Ingredient

The active component, Zolpidem, is a synthetic compound derived from the imidazopyridine chemical class, formulated as a single-ingredient product. The primary dosage form is the oral tablet, delivered via the oral route of administration. It is available in two key pharmaceutical preparations: the immediate-release formulation, designed for rapid action, and the extended-release formulation, which employs specialized technology to sustain its effect throughout the night. This availability allows for flexibility in addressing both the difficulty of falling asleep and the issue of waking too early.

General Purpose of Somno

The general purpose of Somno, based on its established classification as a Hypnotic, is the short-term pharmacological management of sleep cycle disturbances in adults. By selectively acting on the GABAA receptor, the drug effectively lowers the overall level of central nervous system arousal. This action provides the intended benefit of promoting the transition from wakefulness into a sleep state, thus aiding patients experiencing difficulties in initiating and/or sustaining restful periods, such as those with acute or transient insomnia.

What side effects are possible with Somno?

Possible Side Effects and Safety Information for Somno

The most significant safety consideration for Somno is the risk of complex sleep behaviors, which is highlighted by regulatory authorities in a Boxed Warning. These rare but serious events include sleepwalking, sleep driving, or engaging in other activities (such as preparing and eating food, making phone calls, or having sexual intercourse) while not being fully awake. These behaviors have resulted in documented cases of serious injuries and death, which can occur after the first dose and even at the lowest recommended dose. Somno is strictly contraindicated (should never be used) in patients who have previously experienced any complex sleep behavior while taking this or similar insomnia medications.

Commonly reported side effects involve the central nervous system and the gastrointestinal tract, and may include drowsiness, dizziness, diarrhea, and grogginess. These effects, particularly drowsiness and impaired coordination, increase with higher doses and when the drug is used with alcohol or other CNS depressants.

Safety Considerations and Restrictions:

  • Next-Morning Impairment: Due to the risk of reduced alertness and motor coordination lasting into the following day, patients should avoid driving and operating machinery until they are certain the medication has not caused residual impairment.
  • Behavioral Changes: The medication may cause abnormal thoughts and behavioral changes, including agitation, confusion, worsening of depression, and the emergence of suicidal thoughts or actions.
  • Severe Allergic Reactions: Rare but severe allergic reactions, including swelling of the tongue or throat, have been reported.
  • Population Specifics: A lower initial dose is typically recommended for women, who eliminate the drug more slowly than men, increasing their risk of morning impairment. The use of Somno must be avoided entirely in patients with severe hepatic impairment.

Patients who experience a complex sleep behavior or a severe allergic reaction must discontinue the medication immediately.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdose of Somno (melatonin) is generally associated with a low risk of life-threatening events, though serious symptoms can occur, especially with ingestion of very high doses or in combination with other sedating substances. Treatment is supportive as there is no specific antidote.

Overdose symptoms primarily affect the Central Nervous System (CNS) and Gastrointestinal systems. Common presentations include excessive daytime drowsiness, headache, dizziness, nausea, and irritability. Other potential effects are hypothermia, vomiting, and changes to blood pressure or heart rate.

Required Emergency Actions

When to seek immediate medical attention (Call 9-1-1 or go to the Emergency Room):

  • Difficulty breathing or shortness of breath.
  • Seizures.
  • Loss of consciousness or inability to be woken up.

For ingestions not presenting with these severe symptoms, but where overdose is suspected, contact a Poison Control Center (e.g., 1-800-222-1222 in the U.S.) for guidance. Overdose risk can be more significant in children, where more serious outcomes, including need for respiratory support, have been documented.

Therapeutic Uses of Somno

What Somno Treats: Main Uses and Benefits

Somno is commonly used for the short-term pharmacological management of insomnia in adults, and is applied across domains where additional symptomatic support is needed for sleep disturbances. The medication is indicated for managing symptoms of difficulty falling asleep (sleep onset insomnia) and difficulty staying asleep (sleep maintenance insomnia).

The use of Somno is generally considered relevant for easing symptoms that interfere with daily functioning, such as those associated with transient or chronic insomnia patterns. It is applied during phases when symptoms become more noticeable, offering supportive relief when short-term symptomatic assistance is needed.

“The short-term use of this medication helps address symptom clusters that may become intense or disruptive to the normal sleep cycle.”

This supportive role contributes to improved comfort during symptomatic periods, assisting with maintaining functional stability by easing the overall symptom load.


Quick Fact: Relief for Sleep Cycle Disturbances Somno may be part of symptomatic management in clinical settings that involve acute or unstable symptom patterns, and can assist in easing the time needed to transition into sleep and support sleep continuity by helping to address nocturnal awakenings.

Eligibility and Restrictions for Use

Who can and cannot use Somno?

Somno (Zolpidem) is officially approved for use only in adults 18 years and older for the short-term treatment of insomnia.

Use is strictly contraindicated and must be avoided in patients with a history of severe allergic reaction or angioedema to the drug, or those who have previously experienced a complex sleep behavior event (such as sleep-driving). It is also contraindicated for individuals with severe hepatic impairment (severe liver disease), Myasthenia Gravis, severe respiratory insufficiency, or Sleep Apnoea Syndrome.

Age-Related Eligibility

The drug is not recommended for use in children and adolescents under 18 years, as safety and effectiveness have not been established in this age group.

Conditional Use and Restrictions

Special restrictions apply to several populations. Elderly or debilitated patients and adult women are generally advised a lower starting dosage due to reduced drug clearance. Caution is advised in patients with compromised respiratory function, mild to moderate liver impairment, depression, or a history of alcohol or drug abuse.

During late-stage pregnancy, use may lead to neonatal sedation; lactating women are advised to discard breast milk for 23 hours after administration.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for Somno (Zolpidem) details specific interaction patterns across pharmacokinetic and pharmacodynamic domains.

Drug-Drug Interactions

Co-administration with other CNS depressants, including opioids, tricyclic antidepressants, and certain anti-psychotics, results in a risk of pharmacodynamic reinforcement. This effect leads to additive CNS depression, increased sedation, and impaired psychomotor performance. Use with opioids also carries an increased risk of respiratory depression.

The drug’s clearance involves metabolism by the CYP3A4 enzyme. Rifampin, a strong enzyme inducer, significantly decreases zolpidem exposure and can reduce its effect. Conversely, strong enzyme inhibitors, such as Ketoconazole and Itraconazole, increase zolpidem exposure and prolong its half-life, which may elevate next-day effects.

Product and Timing Constraints

Use is formally contraindicated in patients with a history of complex sleep behaviors (e.g., sleep-driving) after prior exposure to zolpidem. Use with Alcohol is not recommended due to severe additive psychomotor impairment.

To mitigate next-day impairment, Somno must be taken only when a patient can ensure a full 7 to 8 hours of sleep opportunity remains. Immediate-release formulations should not be taken with a meal to prevent a delay in the onset of effect. Furthermore, patients with mild to moderate hepatic impairment require dose consideration due to reduced clearance, and use is avoided in those with severe hepatic impairment.

Mechanism of Action

How Somno Works: The Mechanism of Action


Targeted Modulation of Primary Receptor Systems

Somno's action is defined by its ability to engage specific biological targets, primarily specialized receptor systems, where it initiates or blocks key signaling events. This direct interaction is the first step in altering the dynamics of neural or humoral pathways, which leads to alterations in pathway dynamics.


Dampening Overactive Signaling Cascades

The drug's activity extends into subsequent molecular cascades by dampening excessive or dysregulated signaling. By modifying these signal transduction sequences, Somno modifies the transmission patterns within pathways that are characterized by heightened activity or dominance by specific mediators.


Modulation of Core Physiological Responses

Ultimately, Somno's mechanism exerts a targeted effect on key regulatory systems. This results in the modulation of overactive physiological responses. This action alters the activity within targeted central and/or peripheral pathways, which shapes the resulting downstream physiological changes.

Dosage and Administration Information

How to Use Somno: Official Administration Guidelines

Somno (Zolpidem Tartrate) is administered strictly based on the official guidelines for hypnotic agents, focusing on a single nightly intake over the shortest possible duration, typically not exceeding four weeks. The administration protocol is precisely timed and dependent on the chosen formulation and patient profile.

Administration and Dosage Principles

The primary route of administration is oral, encompassing immediate-release (IR) and extended-release (ER) tablets, as well as specific sublingual forms. The lowest effective dose must always be used, and the dose should not be re-administered during the same night.

Formulation Initial Dosing Maximum Dose Key Instruction
IR Tablet (5 mg, 10 mg) 5 mg (women); 5 mg or 10 mg (men) 10 mg Swallow whole; requires at least 7 hours of sleep remaining.
ER Tablet (6.25 mg, 12.5 mg) 6.25 mg (women); 6.25 mg or 12.5 mg (men) 12.5 mg Swallow whole; requires at least 7 hours of sleep remaining.
Sublingual (1.75 mg, 3.5 mg) Dose adjusted based on gender/concurrent CNS use 3.5 mg Place under the tongue; for use when at least 4 hours of sleep remain.

Contextual Use and Adjustments

All doses must be taken immediately before or upon going to bed. Taking the medicine with or immediately following a meal may slow its effect. For older adults and individuals with mild-to-moderate hepatic impairment, the recommended starting dose is lower, at 5 mg for IR tablets and 6.25 mg for ER tablets. Use in individuals under 18 years of age is not recommended due to lack of established data.

Recent Clinical Evidence

Research evidence / Overview of studies for Somno

Evidence for Use in Difficulty Falling Asleep (Sleep Initiation Insomnia)

The primary research for Somno focused on the indications of difficulty falling asleep (sleep initiation insomnia). This evidence primarily comes from short-term, placebo-controlled clinical trials, as well as systematic reviews. These studies included adults who met diagnostic criteria for insomnia. The researchers examined sleep parameters related to the time required to transition into sleep, using both objective (Polysomnography or PSG) and subjective measurements.

Across numerous studies, studies examined measurements of sleep latency in comparison to placebo groups over the initial trial periods. This focus on sleep initiation research explored sleep parameters over defined time intervals, typically ranging up to five weeks. What remains uncertain is the persistence of these findings describe patterns observed in the studies over many months. The follow-up durations were limited in many core studies, and data for certain groups remain insufficient.


Evidence for Use in Difficulty Staying Asleep (Sleep Maintenance Insomnia)

Research was also studied for the indication of waking up during the night. This area studies explored the use of specialized, extended-release formulations. These trials included adults who experienced difficulty staying asleep and examined outcomes such as the total time participants spent awake after initially falling asleep (Wake Time After Sleep Onset or WASO).

Regulatory documentation references the consistency of the evidence submitted in support of the specific product formulation. Long-term effects are not fully established regarding the consistency of the sleep maintenance outcome over periods exceeding six months. The evidence quality varies across studies and formulations, and the degree to which the reported sleep parameters on WASO relate to next-day functional changes is not fully established across all studies.


Research Findings in Specific Populations

Research examined how this medication was evaluated in specific patient groups, particularly older adults. Studies describe patterns related to drug concentrations in the blood that are generally higher and persist longer in older individuals, which has been studied for observed differences in outcomes for this group. Due to these findings, the regulatory information notes differences in dose measured for this group.

Evidence is limited for use in children or adolescents, and subgroup findings are uncertain regarding many complex patient populations. For instance, comparative evidence is lacking for patients with specific psychiatric conditions or other chronic medical illnesses that might affect sleep.

Frequently Asked Questions (FAQ)

Common questions about Somno (FAQ)


Q: Does Somno cause weight gain, according to research?

A: Official information from clinical trials lists an adverse reaction called 'appetite disorder' in a small percentage of patients at a greater frequency than in the placebo group. Weight gain itself is not among the common adverse reactions listed in the primary regulatory information.


Q: Are there any common side effects people mention about Somno?

A: Regulatory documents, such as those detailing clinical trials, indicate that the most commonly reported side effects include drowsiness, dizziness, headache, grogginess, nausea, and diarrhea. These effects are generally associated with how the medicine acts on the central nervous system.


Q: Can Somno be taken with pain relief medicines like ibuprofen?

A: Official prescribing information advises caution when combining Somno with other medications that act as Central Nervous System (CNS) depressants, as this combination can lead to increased sedation and impaired coordination. Official guidance emphasizes that caution is advised when using it alongside any other medication that may depress the Central Nervous System.


Q: Is it okay to use Somno if I sometimes drink alcohol?

A: Regulatory information strongly advises against using Somno with alcohol. The official documentation states that taking the drug with alcohol is not recommended or is contraindicated. This is due to the severe risk of additive impairment, which can increase drowsiness and affect judgment and motor skills.


Q: Does Somno affect my ability to drive the next day?

A: Official warnings highlight the risk of residual effects that can last into the next morning, known as next-morning impairment. This can involve reduced alertness and impaired motor coordination. Official warnings state that patients should not drive or operate machinery until the risk of residual effects and impaired function has passed.


Q: Are there any specific food items that interact with Somno?

A: Official administration instructions state that the immediate-release formulation of Somno should not be taken with or immediately following a full meal. This is a condition of use to avoid delaying the expected onset of the drug's effect.


Q: Does taking Somno affect memory?

A: Reports from clinical trials list memory disorders as an adverse reaction. This can include memory impairment, as well as amnesia (loss of memory), particularly the inability to recall events that happened immediately after taking the dose.


Q: Is it normal to feel a bit groggy when waking up after taking Somno?

A: Official information from clinical studies confirms that drowsiness and grogginess are commonly reported side effects. These effects may sometimes persist into the following day, which is why regulatory warnings exist about potential next-morning impairment.


Q: Does Somno interact with common allergy medications?

A: The official product information warns about potential interactions with medications classified as Central Nervous System (CNS) depressants. Since some common allergy medications (antihistamines) can cause sleepiness, combining them with Somno may lead to increased sedation and dizziness.


Q: What does the official prescribing information say about stopping Somno?

A: The drug is officially indicated for short-term use, typically not exceeding four weeks. Regulatory warnings state that if the medication is stopped, particularly after long-term use, a patient may experience a temporary return or worsening of their sleep difficulties.


Q: Has Somno been studied in pregnant women or breastfeeding mothers?

A: Official regulatory documents contain information regarding use in these populations. Exposure to the medication late in the third trimester of pregnancy may cause sedation or respiratory issues in the newborn. For breastfeeding mothers, it is advised to discard breast milk for a specific period after administration.


Q: Can people with liver or kidney issues use Somno?

A: Regulatory documents state that use is contraindicated in patients with severe hepatic (liver) impairment. For those with mild-to-moderate liver or kidney issues, official guidance indicates that dose adjustments or monitoring may be required due to how the body processes the medication.


Q: Are there any known interactions between Somno and supplements like melatonin?

A: The official warning for Somno relates to Central Nervous System (CNS) depressants. Supplements, like melatonin, that can cause drowsiness may increase the side effects of Somno, such as dizziness and sedation, due to an additive CNS depressant effect.


Q: Does Somno affect blood pressure?

A: Adverse reaction reports from clinical trials indicate that an increase in blood pressure was reported by a small number of patients taking the drug. This effect was reported more frequently than in the placebo group.


Q: Is Somno okay for people with pre-existing heart conditions?

A: The official guidance does not list heart conditions among the primary contraindications. However, the presence of a medical history is relevant, especially given the documented side effects that can affect blood pressure.


Q: Does Somno interact with birth control pills?

A: The prescribing information does not typically list specific interaction warnings regarding oral contraceptives. However, the drug is known to be metabolized by certain liver enzymes (CYP3A4), which is relevant to how many medications, including some hormonal agents, are processed by the body.


Q: Does Somno interact with grapefruit juice?

A: The drug is metabolized by liver enzymes, specifically CYP3A4. Products like grapefruit juice are known to inhibit these enzymes. Consuming inhibitors of these enzymes may increase the concentration of the drug in the body.


Q: Is it common to experience strange dreams while taking Somno?

A: Official reports from clinical trials include adverse events that affect perception and mental status. For instance, reports of hallucinations were noted in the drug group more frequently than in the placebo group.


Q: Does Somno have a risk of dependence?

A: Official regulatory bodies classify Somno (Zolpidem) as a Schedule IV controlled substance. This classification is given because the drug carries a potential for abuse and the development of physical or psychological dependence.


Q: What are the most serious side effects listed in the regulatory documents for Somno?

A: The most significant risk highlighted by regulatory authorities is complex sleep behaviors. These include serious actions like sleep-driving, sleepwalking, or engaging in other activities while not fully awake. These risks are emphasized in a Boxed Warning and can result in serious injury.


Q: Can Somno cause rebound insomnia if stopped suddenly?

A: Official warnings note that rebound insomnia has been reported in studies. This refers to a temporary return or worsening of the initial sleep difficulties after the medication is discontinued, particularly when done abruptly after a longer period of use.


Q: Can I use Somno if I have asthma or breathing issues?

A: Official information states that use is contraindicated in patients with severe respiratory insufficiency. Caution is generally advised for individuals with other compromised respiratory function, such as severe bronchial asthma.


Q: Is Somno considered addictive or habit-forming?

A: Official regulatory bodies classify Somno (Zolpidem) as a Schedule IV controlled substance. This classification is given because the drug carries a potential for abuse and the development of physical or psychological dependence, making it potentially habit-forming.


Q: What are the long-term effects of taking Somno?

A: The drug is approved and primarily studied for short-term use in managing sleep difficulties. Regulatory documents indicate that the consistency of findings for efficacy and safety over periods exceeding six months is not fully established.


Q: Can Somno be used by people with a history of depression or anxiety?

A: Official warnings advise caution for patients with a history of depression or other psychiatric disorders. This is because the medication may cause abnormal thoughts and behavioral changes, including worsening of existing depression.


Q: How does the effectiveness of Somno compare to placebo in studies?

A: Clinical trials examined sleep parameters by comparing results with a placebo (inactive substance). The studies found that the drug improved measurements related to the time required to fall asleep and the amount of time spent awake after initially falling asleep.


Q: What are the typical withdrawal symptoms mentioned for Somno?

A: For individuals who have taken the drug at high doses or for long periods, abrupt discontinuation may result in reported withdrawal symptoms. These symptoms can include anxiety, restlessness, agitation, and nausea.


Q: Does Somno cause changes in appetite?

A: Official reports from clinical trials list the adverse reaction of 'appetite disorder.' This event was reported in a small number of patients taking the drug more frequently than in the group taking the inactive substance (placebo).


Q: Does Somno require lab monitoring or blood tests?

A: Monitoring of certain laboratory values may be recommended for patients who have pre-existing conditions that affect drug clearance, such as liver or kidney impairment.


Q: Can Somno be used by people with a history of alcohol or drug abuse?

A: Official regulatory information advises caution for patients with a history of drug or alcohol abuse or addiction. This warning exists because the medication has a potential for abuse and the development of dependence.


Q: Are generic versions of Somno available?

A: Regulatory bodies, such as the FDA and equivalent agencies in other countries, have approved and listed generic versions of the active ingredient, zolpidem tartrate, for use.


Q: Can Somno be taken alongside over-the-counter cold medicines?

A: The official product information warns about potential additive Central Nervous System (CNS) depressant effects when taken with other medicines that cause sleepiness. This includes some over-the-counter cold and flu medications.

How should Somno be stored and disposed of?

How to Store and Dispose of Somno (Zolpidem Tartrate)

The storage and disposal of this medication must adhere strictly to regulatory requirements.

Requirement Official Condition
Temperature Store at Controlled Room Temperature (20 C to 25 C / 68 F to 77 F).
Protection Keep in the original, tightly closed container and protect from moisture.
Child Safety Must be stored out of the sight and reach of children.

As a Schedule IV Controlled Substance, unused or expired tablets must be handled with care. Disposal should follow federal and local regulations. The primary method is utilizing a drug take-back program. If a take-back program is unavailable, the FDA recommends flushing the tablets down the toilet to prevent dangerous accidental ingestion.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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