Sleeping Pills: Types, Side Effects and What the Evidence Shows

Sleeping pills are medications taken to fall asleep or stay asleep. In 2024, 12.9% of U.S. adults used a sleep aid most days or every day in the past 30 days, according to the National Health Interview Survey^[1]. That total includes 5.2% who used prescription medication, 5.7% who used over-the-counter (OTC) medications or supplements, and 3.7% who used marijuana or CBD products^[1].

Most of this use targets insomnia, one of several sleep disorders whose prevalence is tracked on their own pages. This guide covers the drugs themselves: the classes, what trials found, what regulators have warned about, and how pills compare with non-drug treatment for sleeping problems.

The term covers unrelated drug groups. Prescription options include benzodiazepines such as temazepam and triazolam, the so-called Z-drugs eszopiclone, zaleplon and zolpidem, the orexin receptor antagonists suvorexant, lemborexant and daridorexant, the melatonin receptor agonist ramelteon, and low-dose doxepin^[3][4]. Some drugs without an FDA insomnia indication, trazodone among them, are also prescribed for sleep^[3].

Use rises with age. Prescription sleep medication use ranged from 2.2% of adults 18 to 34 to 8.8% of adults 65 and older in 2024, and women used it more often than men (6.4% vs. 3.9%)^[1].

The 2017 American Academy of Sleep Medicine (AASM) guideline graded individual drugs for chronic insomnia in adults rather than whole classes^[3]. It suggested eight drugs: suvorexant, eszopiclone, zaleplon, zolpidem, triazolam, temazepam, ramelteon and doxepin^[3].

It suggested against six: trazodone, tiagabine, diphenhydramine, melatonin, tryptophan and valerian^[3]. Each suggestion names the type of insomnia it covers: zaleplon, triazolam and ramelteon were suggested for falling asleep, and suvorexant and doxepin for staying asleep^[3].

Every recommendation in the guideline was graded weak. Under the GRADE method the AASM used, a weak rating reflects lower certainty in the evidence and is not a sign that a drug is ineffective^[3].

The largest comparison of sleeping pills is a 2022 network meta-analysis in The Lancet that pooled 154 double-blind randomized trials with 44,089 adults with insomnia disorder^[4]. It compared 30 treatments on sleep quality, dropouts and side effects, separately for acute and long-term treatment^[4].

For acute treatment, benzodiazepines, doxylamine, eszopiclone, lemborexant, seltorexant, zolpidem and zopiclone all improved sleep quality more than placebo^[4]. Benzodiazepines, eszopiclone, zolpidem and zopiclone also outperformed melatonin, ramelteon and zaleplon^[4].

The drugs that worked best short term also produced more side effects. Benzodiazepines, eszopiclone, zolpidem and zopiclone left more people with adverse events than placebo, doxepin, seltorexant or zaleplon^[4].

For long-term treatment, only eszopiclone and lemborexant beat placebo, and the certainty of that evidence was rated very low^[4]. The authors judged the two to have the most favorable overall profile, while cautioning that eszopiclone might cause substantial adverse events and that lemborexant's safety data were inconclusive^[4].

No single top three emerges from this evidence. Rankings shift depending on whether short-term sleep quality, tolerability or long-term data is weighted most^[4].

More adults use OTC medications or supplements to sleep than use prescription drugs: 5.7% did so most days or every day in 2024^[1]. Diphenhydramine, an antihistamine also used for allergy and cold symptoms, is used to treat insomnia in adults^[7].

The AASM suggested that clinicians not use diphenhydramine for either falling or staying asleep^[3]. Its listed side effects include dry mouth, drowsiness, dizziness and difficulty urinating^[7]. Doxylamine, another antihistamine, did outperform placebo in short-term trials in the 2022 Lancet analysis^[4].

Melatonin is sold in the U.S. as a dietary supplement, which the FDA regulates less strictly than prescription or OTC drugs; several other countries treat it as a prescription drug^[8]. Both the AASM (2017) and ACP (2016) guidelines found too little strong evidence to recommend melatonin for chronic insomnia^[8].

Melatonin has more support for other uses, including jet lag and delayed sleep-wake phase disorder, one of the circadian rhythm disorders^[8]. Short-term use appears safe for most people, but information on long-term safety is lacking^[8].

Product content adds uncertainty. A 2023 JAMA analysis of 25 melatonin gummy products found 22 (88%) were inaccurately labeled, with measured melatonin ranging from 74% to 347% of the labeled amount; one contained no detectable melatonin^[9].

In April 2019 the FDA added a boxed warning to eszopiclone (Lunesta), zaleplon (Sonata) and zolpidem (Ambien and other brands)^[6]. The warning covers complex sleep behaviors, such as sleepwalking and sleep driving, that have led to serious injuries and deaths^[6].

The FDA told clinicians not to prescribe these three drugs to anyone who has had a complex sleep behavior after taking one of them^[6]. It said these behaviors appear more common with the three Z-drugs than with other prescription sleep medicines^[6].

In September 2020 the FDA required an updated boxed warning, its most prominent warning, for all benzodiazepines, covering abuse, addiction, physical dependence and withdrawal^[10]. The agency stated that physical dependence can develop when benzodiazepines are taken steadily for several days to weeks, even as prescribed, and that stopping abruptly can cause withdrawal reactions including seizures^[10].

In trials, zolpidem caused more dropouts due to side effects than placebo in both short-term and long-term analyses^[4]. The ACP guideline notes that observational studies have associated hypnotic drugs with dementia and fractures, an association rather than proof of cause^[2].

FDA product labels also warn about driving impairment and recommend lower doses of benzodiazepine and non-benzodiazepine hypnotics for women and for older or debilitated adults, according to the ACP^[2].

Older adults are the heaviest users: 8.8% of adults 65 and older took prescription sleep medication most days or every day in 2024, four times the rate among adults 18 to 34^[1].

A 2005 BMJ meta-analysis of 24 trials with 2,417 participants aged 60 and older found sedative hypnotics increased total sleep time by about 25 minutes compared with placebo^[5]. Adverse cognitive events were 4.78 times as common and daytime fatigue 3.82 times as common with the drugs^[5].

The authors estimated a number needed to treat of 13 for improved sleep quality and a number needed to harm of 6 for any adverse event, so an adverse event was more than twice as likely as better sleep^[5]. They concluded that in people over 60 the benefits may not justify the increased risk^[5].

That 2005 analysis tested benzodiazepines, zopiclone, zolpidem, zaleplon and diphenhydramine, so it says nothing about the newer orexin receptor antagonists^[5].

Guidelines do not answer this with a simple yes or no. The ACP judged the evidence insufficient to weigh the benefits and harms of long-term use, and it describes FDA approval of these drugs as covering short-term use of 4 to 5 weeks^[2].

Long-term trial data are thin. In the 2022 Lancet analysis, eszopiclone and lemborexant were the only drugs that outperformed placebo over the long term, at very low certainty^[4].

Real-world use often runs longer than the trials. The FDA estimated that in 2018 half of patients dispensed oral benzodiazepines received them for two months or longer, and these drugs are prescribed for anxiety and seizures as well as insomnia^[10]. The anxiety medication guide covers that use.

The ACP's 2016 guideline gives a strong recommendation, based on moderate-quality evidence, that all adults with chronic insomnia receive cognitive behavioral therapy for insomnia (CBT-I) as the initial treatment^[2]. It recommends shared decision-making about adding short-term medication only when CBT-I alone has not worked^[2].

A 2015 meta-analysis of 20 trials with 1,162 participants found that after CBT-I, people fell asleep about 19 minutes faster and spent about 26 fewer minutes awake after first falling asleep^[11]. Sleep efficiency improved by 9.91 percentage points, the gains appeared to last at later follow-up, and no adverse outcomes were reported^[11].

The ACP found too little evidence to compare CBT-I and sleeping pills head to head. It reasoned that because CBT-I is noninvasive it is likely to carry fewer harms than drug treatment^[2].

Not every sleeping problem is insomnia. Conditions such as sleep apnea are assessed and treated differently; the sleep disorders overview covers each one.