Ambien Hair and Skin Changes: What Zolpidem Actually Does to Your Body

What zolpidem is, and where skin reactions sit in its label

Zolpidem tartrate is an oral prescription sedative-hypnotic for short-term insomnia, and the label classifies it as a Schedule IV controlled substance [1]. The immediate-release tablet (Ambien) was approved on 16 December 1992, the extended-release tablet (Ambien CR) on 2 September 2005, and the sublingual tablet (Edluar) on 13 March 2009 [3]. Intermezzo and Zolpimist are listed as discontinued in Drugs@FDA [3].

The boxed warning carried by the zolpidem labels is about complex sleep behaviors — sleep-walking, sleep-driving and other activities while not fully awake — not about skin [1]. Skin and allergic reactions sit in the Warnings and Precautions section and in the Contraindications section [1].

Angioedema and anaphylaxis: the serious end of the skin story

The Ambien label states that 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 [1]. Some patients had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis, and some required medical therapy in an emergency department [1]. If angioedema involves the throat, glottis or larynx, airway obstruction may occur and be fatal [1].

The label is direct about what follows a reaction: patients who develop angioedema after zolpidem should not be rechallenged with the drug [1]. Known hypersensitivity to zolpidem is a contraindication, and the reactions observed include anaphylaxis and angioedema [1]. The Ambien CR label carries the same angioedema, anaphylaxis and hypersensitivity language [2].

Rash and urticaria: what the trials actually counted

In the Ambien label, the table drawn from three placebo-controlled trials lasting 28 to 35 nights (zolpidem up to 10 mg, 152 patients; placebo, 161 patients) lists rash in 2% of zolpidem patients versus 1% on placebo, and allergy in 4% versus 1% [1]. The shorter table, from 11 placebo-controlled trials lasting up to 10 nights (685 patients on zolpidem, 473 on placebo), lists no skin reaction among the events reported in at least 1% of zolpidem patients and more often than with placebo; the events there are headache, drowsiness, dizziness and diarrhea [1].

The Ambien CR label reports a different set from its own studies. In the 3-week trial of the 12.5 mg dose in adults (102 patients on zolpidem, 110 on placebo), rash, urticaria and skin wrinkling each appeared in 1% of zolpidem patients and 0% of placebo patients [2].

Those percentages should not be read as a ranking of formulations. The label itself cautions that trial frequencies cannot be compared with figures from other trials involving related products because the conditions differ [1]. The two sets of numbers come from separate studies with different designs and durations.

Does zolpidem cause hair loss?

The trial tables list only reactions reported by at least 1% of zolpidem patients and more often than with placebo. Hair loss or alopecia is not among the reactions in the Ambien tables or the Ambien CR adult 12.5 mg table [1][2]. The skin-related entries there are rash, allergy, urticaria and skin wrinkling.

Does the dose or the formulation change the risk?

The label does not tie angioedema to a particular dose; it describes cases after the first or any later dose [1]. The Ambien CR label uses the same wording [2].

Reporting a suspected reaction

The label directs suspected adverse reactions to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch [1].